FDA.reportPublic FDA data

NDC 67046-2080-03 - HydrALAZINE Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
67046-2080
Requested NDC
67046-2080-03
Package NDCs from labels
67046-2080-3, 67046-2080-03
Manufacturer
Coupler LLC | Strides Pharma Global Pte. Ltd.
Effective date
2026-08-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HydrALAZINE HYDROCHLORIDE TABLETS, USPCoupler LLC | Strides Pharma Global Pte. Ltd.2026-08-07HUMAN PRESCRIPTION DRUG LABEL

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 1 of 6 · 103 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.51c293c1-70e7-48c7-8af1-a8b74312ed562026-09-08Warnings, Adverse reactionsExact identifier
rxcui: 905222
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.6c40d818-77a9-492c-b9b6-d8a0fe8d67362026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 905225
unii: FD171B778Y
hydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.dca82025-a4cd-4856-aa19-bdf091bf89732026-08-14Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepackd2d98842-ff32-4a61-94e0-60e06919948f2026-08-14Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905222
unii: FD171B778Y
HydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDECoupler LLC58773e8c-b6bc-6bc6-e063-6294a90adc262026-08-07Warnings, Adverse reactionsExact identifier
application number: ANDA200770
ndc (package): 67046-2080-3
ndc (product): 67046-2080
ndc11 (package): 67046208003
rxcui: 905395
spl id: 58773dbd-7c36-7daa-e063-6394a90a6666
spl set id: 58773e8c-b6bc-6bc6-e063-6294a90adc26
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECardinal Health 107, LLCdb7500f3-f8a6-46b1-bb64-9727617a96432026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEMajor Pharmaceuticalsb6ccd35e-f69c-4eef-a456-905e030ae9112026-07-15Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
rxcui: 905222
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENorthwind Health Company, LLC1275dd50-d97f-2e8f-e063-6394a90a4a672026-06-22Warnings, Adverse reactionsExact identifier
rxcui: 905225
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECardinal Health 107, LLC8b7e88ef-5edd-40df-8e43-e3f29970be582026-06-19Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.d61ffa06-8138-4a1d-9530-095a80d9c9ce2026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.a70d20d6-23f0-477e-915c-678a867821752026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 905199
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.0d65e146-83e5-427f-ac06-04c0d8e72cea2026-06-09Warnings, Adverse reactionsExact identifier
rxcui: 905225
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECardinal Health 107, LLC43ce0ecb-6d62-44bf-8539-823ae03eb9f42026-06-03Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECardinal Health 107, LLCa1066707-2391-4918-8ded-600c017fde482026-05-18Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.438479d0-ff61-4008-a0fc-1ee44b97cf7f2026-05-07Warnings, Adverse reactionsExact identifier
rxcui: 905222
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.f0db9c3c-d841-46f9-8409-9ffca83d7a972026-05-06Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENavinta LLCae5d85df-11a3-4952-ade2-596d57cdd9872026-04-21Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.669532c9-ba15-4f4b-95a8-13782deb35212026-04-03Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
rxcui: 905222
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDESafecor Health, LLC66c5eaa4-a51a-464b-98ad-f094f32876dd2026-03-11Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.f3c806a4-b971-421c-bcb9-9979c6d7aaec2026-02-27Warnings, Adverse reactionsExact identifier
unii: FD171B778Y

Reported adverse events (FAERS/openFDA)#

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