FDA.reportPublic FDA data

Application 213352

Type
ANDA
Sponsor
AREVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDESOLUTION;INTRAVENOUS10MG/4ML (2.5MG/ML)NoNo
002VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDESOLUTION;INTRAVENOUS5MG/2ML (2.5MG/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213352-001VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-17
A213352-002VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A213352-001AP
A213352-002AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A213352-001VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-17a50c72e98297…
2026-08-01 22:54:322026-06A213352-002VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-09-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A213352-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A213352-002AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstdf79ee3a-f0ed-1cc7-e053-2995a90af97f2026-07-23Warnings, Adverse reactionsName fallback
brand name: VERAPAMIL HYDROCHLORIDE
generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDELifestar Pharma LLCdf77b8d1-1d2b-4fea-a1e9-153bd25008a62026-07-10Warnings, Adverse reactionsName fallback
brand name: verapamil hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEHospira, Inc.1c993365-1b62-4524-e781-d307f28f63bc2026-07-09Warnings, Adverse reactionsName fallback
brand name: Verapamil Hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEREMEDYREPACK INC.ce9ab27a-e03b-4e40-a0e0-b586cd75dead2026-06-29Warnings, Adverse reactionsName fallback
brand name: verapamil hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDESomerset Therapeutics, LLC50131bbc-ad43-4708-946f-e4000828137c2026-06-24Warnings, Adverse reactionsName fallback
brand name: Verapamil Hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDESafecor Health LLCbf7b5037-7355-4788-b17b-323c18a5aee72026-06-23Warnings, Adverse reactionsName fallback
brand name: Verapamil Hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEHenry Schein, Inc.4f6ae43f-c28a-4eac-9b19-8b5d0c12dfaa2026-06-19Warnings, Adverse reactionsName fallback
brand name: Verapamil Hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEREMEDYREPACK INC.5dc5f087-c8da-4ed0-b532-ae44508958aa2026-06-01Warnings, Adverse reactionsName fallback
brand name: verapamil hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDENivagen Pharmaceuticals, Inc.e36e485f-fbed-4e30-9a63-984931f2e54e2026-05-13Warnings, Adverse reactionsName fallback
brand name: VERAPAMIL HYDROCHLORIDE
generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst4dcc46d8-76b0-fbd4-e063-6294a90ad9e62026-05-05Warnings, Adverse reactionsName fallback
brand name: VERAPAMIL HYDROCHLORIDE
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEHospira, Inc.70057a53-ca29-4848-ab3d-5e691e2a14a32026-04-29Warnings, Adverse reactionsName fallback
brand name: Verapamil Hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEZydus Lifesciences Limited051392d3-8ec1-450c-8c38-791d4ef1a2db2026-04-09Name fallback
brand name: Verapamil hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
Verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.e19ab8d8-dae5-489d-9805-7e7407bea06d2026-04-06Warnings, Adverse reactionsName fallback
brand name: Verapamil hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst4dcb137e-b01a-eb3a-e063-6294a90aaecc2026-03-24Warnings, Adverse reactionsName fallback
brand name: VERAPAMIL HYDROCHLORIDE
generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEBryant Ranch Prepack1de6ad5c-942e-4381-b01f-e5e63bbf72ef2026-03-10Warnings, Adverse reactionsName fallback
brand name: VERAPAMIL HYDROCHLORIDE
generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEA-S Medication Solutionse07b3574-9259-4f64-a9ae-f4e0e64800b62026-03-07Warnings, Adverse reactionsName fallback
brand name: verapamil hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDECadila Pharmaceuticals Limited5501208c-aa2b-47aa-89f7-87f4d4a73fd02026-02-09Warnings, Adverse reactionsName fallback
brand name: VERAPAMIL HYDROCHLORIDE
generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDEAvKAREa32f346e-71cf-cc11-e053-2a95a90ae88c2026-01-15Warnings, Adverse reactionsName fallback
brand name: VERAPAMIL HYDROCHLORIDE
generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3c215e6c-d85a-4102-a1c2-f00fa3169a552026-01-08Warnings, Adverse reactionsName fallback
brand name: verapamil hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.9d529fe3-7b5c-4dde-9a8c-440a969df3592026-01-05Warnings, Adverse reactionsName fallback
brand name: verapamil hydrochloride
generic name: VERAPAMIL HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59923-605Verapamil HydrochlorideVerapamil HydrochlorideAreva PharmaceuticalsANDACurrent
59923-605Verapamil HydrochlorideVerapamil HydrochlorideAreva PharmaceuticalsANDACurrent
59923-605Verapamil HydrochlorideVerapamil HydrochlorideAreva PharmaceuticalsANDACurrent