{"answer":{"query":"Valacyclovir","resolved_as":"applications","packages":226,"applications":["ANDA076588","ANDA201506","ANDA203047","ANDA209553"],"identity":{"application_numbers":["ANDA076588","ANDA201506","ANDA203047","ANDA209553"],"marketing_categories":["ANDA"],"labelers":[{"text":"JUBILANT CADISTA PHARMACEUTICALS, INC.","untrusted":true}],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true},{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2012-04-05","latest":"2026-10-20","packages_with_a_start_date":226}},"label_history":{"events_total":19,"non_cmc_events":18,"counts_by_class":{"LABELING":18},"cmc_events":1,"recent_non_cmc_events":[{"application":"ANDA203047","submission_no":20,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-06-10","documents":[],"fact_id":"5a2616080d273f43e2fcc8d0"},{"application":"ANDA201506","submission_no":26,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-01-30","documents":[],"fact_id":"f0ce356e659e1e8f315eb9ae"},{"application":"ANDA201506","submission_no":25,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-01-30","documents":[],"fact_id":"3caf80523fa4d632a4ea30ce"},{"application":"ANDA201506","submission_no":24,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-01-30","documents":[],"fact_id":"b2f1e345963c5e2129327762"},{"application":"ANDA201506","submission_no":22,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-04-17","documents":[],"fact_id":"0b4192f152fa4667d0bfe55c"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":8,"te_code_counts":{"AB":8},"marketing_status_counts":{"Prescription":8},"meaning":"raw FDA codes; the therapeutic equivalence code says whether FDA rates a generic as substitutable, and what that means for a given prescription is for a pharmacist or prescriber","products":[{"application":"ANDA076588","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"VALACYCLOVIR HYDROCHLORIDE","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 500MG BASE","untrusted":true}},{"application":"ANDA076588","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"VALACYCLOVIR HYDROCHLORIDE","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 1GM BASE","untrusted":true}},{"application":"ANDA201506","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"VALACYCLOVIR HYDROCHLORIDE","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 1GM BASE","untrusted":true}},{"application":"ANDA201506","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"VALACYCLOVIR HYDROCHLORIDE","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 500MG BASE","untrusted":true}},{"application":"ANDA203047","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"VALACYCLOVIR HYDROCHLORIDE","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 1GM BASE","untrusted":true}},{"application":"ANDA203047","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"VALACYCLOVIR HYDROCHLORIDE","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 500MG BASE","untrusted":true}},{"application":"ANDA209553","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"VALACYCLOVIR HYDROCHLORIDE","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 1GM BASE","untrusted":true}},{"application":"ANDA209553","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"VALACYCLOVIR HYDROCHLORIDE","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 500MG BASE","untrusted":true}}]},"recalls":{"recalls_total":1,"counts_by_class":{"Class II":1},"packages_of_these_applications":226,"most_recent":[{"recall_number":"D-0602-2018","classification":"Class II","status":"Terminated","report_date":"2018-03-21","recall_initiated":"2018-02-13","recalling_firm":{"text":"Hetero Labs Limited Unit V","untrusted":true},"reason":{"text":"Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).","untrusted":true},"packages_named":12,"fact_id":"f787482318e55f03c63bd9f6"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"supply":{"fda_shortage_status_counts":{},"packages_with_a_termination_date":1,"next_package_termination_dates":[],"packages_with_future_termination_date":0,"termination_meaning":"manufacturer-reported last-lot expiry or withdrawal date of one package; other packages and generics can remain"},"spending":{"reported_under":{"generic":{"text":"Valacyclovir HCl","untrusted":true},"brand":{"text":"Valacyclovir","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":106636703.57,"claims":2437055,"beneficiaries":1104303,"average_spending_per_claim_usd":43.756379552,"fact_id":"09050ba5af9661f755fc174b"},{"year":2021,"gross_spending_usd":112289691.49,"claims":2539328,"beneficiaries":1185594,"average_spending_per_claim_usd":44.22023917,"fact_id":"3e894472001dafaa35625b81"},{"year":2022,"gross_spending_usd":124083317.35,"claims":2716955,"beneficiaries":1270210,"average_spending_per_claim_usd":45.669993559,"fact_id":"732ed6607f9b2039b7681c67"},{"year":2023,"gross_spending_usd":121564499.19,"claims":2950159,"beneficiaries":1382297,"average_spending_per_claim_usd":41.206083872,"fact_id":"bd75e74e324675b807218548"},{"year":2024,"gross_spending_usd":106800449.21,"claims":3299119,"beneficiaries":1534398,"average_spending_per_claim_usd":32.372414942,"fact_id":"f74d706d7971bcfb8dfecbc0"}],"rebate_caveat":"CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions.","not_a_patient_price":"Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.","meaning":"a drug-level aggregate of Medicare Part D claims for all manufacturers combined; not a formulary, not coverage","source":{"dataset":{"text":"data-year-2024, modified 2026-06-25","untrusted":true},"link":{"text":"https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-d-spending-by-drug","untrusted":true}}},"medicaid_state_utilization":{"year":2025,"states_with_data":23,"all_states_medicaid_reimbursed_usd":214957.83,"all_states_medicaid_paid_prescriptions":12577,"top_states":[{"state":"ME","medicaid_paid_prescriptions":1963,"medicaid_reimbursed_usd":43743.07,"total_reimbursed_usd":44078,"packages":2,"covers":"all_record_types","fact_id":"926f6d3c410bf71adeadecb0"},{"state":"MO","medicaid_paid_prescriptions":1699,"medicaid_reimbursed_usd":37656.02,"total_reimbursed_usd":37949.76,"packages":2,"covers":"all_record_types","fact_id":"3612caf3b0a66a83f1530f9d"},{"state":"MA","medicaid_paid_prescriptions":1409,"medicaid_reimbursed_usd":28457.95,"total_reimbursed_usd":28502.42,"packages":3,"covers":"fee_for_service_only","fact_id":"72827c916af0e6397385cc02"},{"state":"CT","medicaid_paid_prescriptions":764,"medicaid_reimbursed_usd":17389.13,"total_reimbursed_usd":17395.66,"packages":2,"covers":"all_record_types","fact_id":"2f3e1af56ab68e84e9d300cf"},{"state":"MD","medicaid_paid_prescriptions":1591,"medicaid_reimbursed_usd":14146.16,"total_reimbursed_usd":15703.41,"packages":1,"covers":"fee_for_service_only","fact_id":"beb728fad09940128ed68a13"},{"state":"TX","medicaid_paid_prescriptions":966,"medicaid_reimbursed_usd":12722.7,"total_reimbursed_usd":12785.39,"packages":2,"covers":"fee_for_service_only","fact_id":"25bb4c51251277e063ce36ef"},{"state":"PR","medicaid_paid_prescriptions":964,"medicaid_reimbursed_usd":12550.01,"total_reimbursed_usd":12555.62,"packages":3,"covers":"all_record_types","fact_id":"9fb740a17f77bea5e7bd006d"},{"state":"VT","medicaid_paid_prescriptions":566,"medicaid_reimbursed_usd":10349.55,"total_reimbursed_usd":10400.28,"packages":2,"covers":"all_record_types","fact_id":"662222c907e25d297c63a980"},{"state":"NH","medicaid_paid_prescriptions":608,"medicaid_reimbursed_usd":7405.19,"total_reimbursed_usd":7405.19,"packages":2,"covers":"all_record_types","fact_id":"cdd042859ad36e4b4e6615ae"},{"state":"DC","medicaid_paid_prescriptions":369,"medicaid_reimbursed_usd":5054.02,"total_reimbursed_usd":6147.54,"packages":2,"covers":"fee_for_service_only","fact_id":"139ce688d26dc4e3daae6f49"}],"unlabelled_state_code_xx":null,"built_from_facts":36,"facts_fee_for_service_only":14,"older_year_facts_not_used":327,"dataset":"State Drug Utilization Data 2025","read_on":"2026-11-07T22:41:44.201Z","reading":"Medicaid prescriptions and reimbursement by state (CMS State Drug Utilization Data). 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See the provenance tool for each fact's licence label."},"unknown":[{"code":"NO_DATA","field":"price","reason":"no NADAC price, negotiated price or federal upper limit for these packages"},{"code":"NO_DATA","field":"generic_entry:ANDA076588","reason":"no generic-entry fact for this application: no patent or exclusivity is listed for it in the Orange Book edition read, so no date is stated"},{"code":"NO_DATA","field":"generic_entry:ANDA201506","reason":"no generic-entry fact for this application: no patent or exclusivity is listed for it in the Orange Book edition read, so no date is stated"},{"code":"NO_DATA","field":"generic_entry:ANDA203047","reason":"no generic-entry fact for this application: no patent or exclusivity is listed for it in the Orange Book edition read, so no date is stated"},{"code":"NO_DATA","field":"generic_entry:ANDA209553","reason":"no generic-entry fact for this application: no patent or exclusivity is listed for it in the Orange Book edition read, so no date is stated"},{"code":"NO_DATA","field":"generic_entry","reason":"no application of this drug has a generic-entry fact; no date is stated"},{"code":"NO_DATA","field":"trials","reason":"no ClinicalTrials.gov record set for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"assistance_and_offers","reason":"no assistance program lists this drug and no manufacturer offer naming it is recorded; that does not mean none exists"},{"code":"NO_DATA","field":"policy","reason":"no Federal Register event in the edition names this drug or its programs"},{"code":"NO_DATA","field":"biologic_status","reason":"no biologic application of this drug has a Purple Book status in the edition (a drug that is not a biologic has none)"},{"code":"NO_DATA","field":"payment_limit","reason":"no HCPCS code whose NDC crosswalk names a package of these applications has a Part B payment limit in the edition"},{"code":"NO_DATA","field":"rems","reason":"no REMS@FDA program is tied to these applications in the edition (most drugs have none)"},{"code":"NO_DATA","field":"controlled_schedule","reason":"no DEA schedule entry matched this drug's ingredient in the edition"},{"code":"NO_DATA","field":"orphan_designation","reason":"no FDA orphan designation for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"safety_communication","reason":"no FDA Drug Safety Communication names this drug's ingredient in the edition"}],"disclaimer":"OmniRx is a reference layer of dated public facts, not clinical advice and not a guarantee of price, coverage or eligibility. Each answer lists the facts it rests on."}