FDA.reportPublic FDA data

Application 086243

Type
ANDA
Sponsor
HERITAGE PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDETABLET; ORAL25MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECoupler LLC4aa1b3e8-9389-fe2c-e063-6294a90a7fb92026-02-12Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.89afc8ef-27c4-489a-81de-3f8f65f6bbb82026-02-09Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
HydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEStrides Pharma Science Limitedb3d1786d-c3ff-42f1-a09f-37a9c9021e5a2026-02-02Warnings, Adverse reactionsName fallback
brand name: HydrALAZINE Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.a04eefaf-ba3c-448d-8ece-4aa9ab2e35082026-01-09Warnings, Adverse reactionsName fallback
brand name: HYDRALAZINE HYDROCHLORIDE
generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.e9450e82-329f-4fd8-a0b3-3e8e227159652026-01-07Warnings, Adverse reactionsName fallback
brand name: HYDRALAZINE HYDROCHLORIDE
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEFresenius Kabi USA, LLCbf1b7c2f-535c-45bb-928a-65606d87685e2025-12-16Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEChartwell RX, LLC0c7f9bd0-6c0a-4521-b77a-3582faa968742025-12-10Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEA-S Medication Solutions7253aaa0-e272-499f-9bfa-304e9556a8fb2025-12-05Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEA-S Medication Solutionsf16f1d87-f9e6-4555-9baf-26ff17cb1d282025-12-05Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEFresenius Kabi USA, LLCf34904dc-c945-4de4-8594-34e4f4ac19832025-11-28Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEEugia US LLCe08d8b6c-a184-4dd5-84ef-bac90e4b1c332025-11-11Warnings, Adverse reactionsName fallback
brand name: HYDRALAZINE HYDROCHLORIDE
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECardinal Health 107, LLC336b11da-e592-4386-921f-3c136d754f2a2025-11-06Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECoupler LLC41c019e3-7b07-5f12-e063-6294a90a53652025-10-22Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEMedical Purchasing Solutions, LLC3f8fb1fc-ffef-4f94-e063-6294a90a2b822025-09-24Warnings, Adverse reactionsName fallback
brand name: HYDRALAZINE HYDROCHLORIDE
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEMylan Institutional Inc.493a8b7e-5bb1-4db2-91a7-77ed878641312025-07-22Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
hydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEProPharma Distribution3855c3da-ff25-8301-e063-6294a90a22b32025-07-18Warnings, Adverse reactionsName fallback
brand name: hydrALAZINE Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEProficient Rx LP024ac6b8-5ce0-4435-9b11-b1806c511d7b2025-07-01Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEHenry Schein, Inc.4d1f55aa-e924-4540-ae9f-bd7362a82f332025-05-20Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepacka79ddc89-546b-4808-879d-c0f5921416362025-03-31Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack90c18c55-3045-4a10-a2bb-012e4a5e15642025-03-25Warnings, Adverse reactionsName fallback
brand name: Hydralazine Hydrochloride
generic name: HYDRALAZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.