FDA.reportPublic FDA data

NDC 68071-2055-06 - 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
68071-2055
Requested NDC
68071-2055-06
Package NDCs from labels
68071-2055-3, 68071-2055-6, 68071-2055-9, 68071-2055-06
Manufacturer
NuCare Pharmaceuticals, Inc.
Effective date
2024-07-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HYDRALAZINE HYDROCHLORIDE TABLETS, USPNuCare Pharmaceuticals, Inc.2024-07-16HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-2055-32023-09-22HYDRALAZINE HYDROCHLORIDE TABLETS, USP
68071-2055-62023-09-22HYDRALAZINE HYDROCHLORIDE TABLETS, USP
68071-2055-92023-09-22HYDRALAZINE HYDROCHLORIDE TABLETS, USP
68071-2055-32023-01-30HYDRALAZINE HYDROCHLORIDE TABLETS, USP
68071-2055-62023-01-30HYDRALAZINE HYDROCHLORIDE TABLETS, USP
68071-2055-92023-01-30HYDRALAZINE HYDROCHLORIDE TABLETS, USP
68071-2055-32021-02-23HYDRALAZINE HYDROCHLORIDE TABLETS, USP
68071-2055-62021-02-23HYDRALAZINE HYDROCHLORIDE TABLETS, USP
68071-2055-92021-02-23HYDRALAZINE HYDROCHLORIDE TABLETS, USP
68071-2055-32021-01-29HYDRALAZINE HYDROCHLORIDE TABLETS, USP
68071-2055-62021-01-29HYDRALAZINE HYDROCHLORIDE TABLETS, USP
68071-2055-92021-01-29HYDRALAZINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2055-3Hydralazine Hydrochloride30 in 1 BOTTLETABLET304
68071-2055-6Hydralazine Hydrochloride60 in 1 BOTTLETABLET604
68071-2055-9Hydralazine Hydrochloride90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2055HYDRALAZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 3 package rows20240717_3b61d1b0-c699-67a8-e054-00144ff88e88.zip

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
application number: ANDA040901
rxcui: 905225
rxcui: 905222
unii: FD171B778Y
HydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDECoupler LLC58773e8c-b6bc-6bc6-e063-6294a90adc262026-08-07Warnings, Adverse reactionsExact identifier
rxcui: 905395
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
application number: ANDA040901
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.