NDC 68071-5285-01 - 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
- 68071-5285
- Requested NDC
- 68071-5285-01
- Package NDCs from labels
- 68071-5285-1, 68071-5285-01
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2024-12-17
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| HYDRALAZINE HYDROCHLORIDE TABLETS, USP | NuCare Pharmaceuticals,Inc. | 2024-12-17 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-5285-1 | Hydralazine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-5285 | HYDRALAZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20241219_a862321d-ebc1-7676-e053-2995a90a5861.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 90c18c55-3045-4a10-a2bb-012e4a5e1564 | 2025-03-25 | Warnings, Adverse reactions | ANDA040901 905395 FD171B778Y |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | 5da36930-d3da-4b5c-9e22-2b141bc01a9c | 2025-03-13 | Warnings, Adverse reactions | ANDA040901 31722-522 905225 905199 905395 905222 30381b85-deb3-bc70-e063-6294a90ad921 5da36930-d3da-4b5c-9e22-2b141bc01a9c FD171B778Y |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | Baxter Healthcare Corporation | f1a10203-f027-4f9c-8dd6-907c6db24d47 | 2025-03-10 | Warnings, Adverse reactions | FD171B778Y |
| YVTYVT MICRODERMABRASION FACIAL SCRUB | YVTYVT MICRODERMABRASION FACIAL SCRUB | Beijing JUNGE Technology Co., Ltd. | 2f30fc45-42e2-c766-e063-6394a90a8d68 | 2025-02-28 | Warnings | OP1R32D61U |
| isosorbide dinitrate and hydralazine hydrochloride | ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE | A2A Integrated Pharmaceuticals | ae757a78-89e8-4f79-81de-d558db3f72a4 | 2025-02-28 | Warnings, Adverse reactions | FD171B778Y |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Coupler LLC | 2e9688ef-781c-aead-e063-6294a90a7bca | 2025-02-20 | Warnings, Adverse reactions | 905199 FD171B778Y |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | Coupler LLC | 2df51a19-a39a-0ec8-e063-6394a90a147c | 2025-02-12 | Warnings, Adverse reactions | 905395 FD171B778Y |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Proficient Rx LP | 775e99c4-e18d-4648-a0e3-8709950249ff | 2025-02-01 | Warnings, Adverse reactions | ANDA040901 905222 FD171B778Y |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 94530e4d-b1c0-6171-e053-2a95a90a05fa | 2025-01-08 | Warnings, Adverse reactions | FD171B778Y |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 7ae650f7-a481-4637-a9a2-9bda43a5a288 | 2024-12-24 | Warnings, Adverse reactions | 905225 FD171B778Y |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | a862321d-ebc1-7676-e053-2995a90a5861 | 2024-12-17 | Warnings, Adverse reactions | ANDA040901 68071-5285-1 68071-5285 68071528501 905222 297a3678-170d-5f0f-e063-6394a90aec48 a862321d-ebc1-7676-e053-2995a90a5861 FD171B778Y |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | ff2c4d1e-33ee-40d7-955b-d736f0559f39 | 2024-12-03 | Warnings, Adverse reactions | 905225 FD171B778Y |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 10f3e76e-9bba-4151-89fb-90d823a0a68c | 2024-11-08 | Warnings, Adverse reactions | 905225 FD171B778Y |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | American Health Packaging | 2e82655e-8435-46fa-b734-8e7c6e803453 | 2024-09-23 | Warnings, Adverse reactions | 905225 905199 905395 FD171B778Y |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Macleods Pharmaceuticals Limited | f9f56326-6d72-47d3-89ac-3625b8a6d713 | 2024-09-06 | Warnings, Adverse reactions | 905225 905199 905395 905222 FD171B778Y |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | f07abdec-6d94-45b6-be1b-10a898ea28c2 | 2024-08-12 | Warnings, Adverse reactions | ANDA040901 905222 FD171B778Y |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | A-S Medication Solutions | 8ade1ffe-3738-4aa1-b9c7-59f7290600b9 | 2024-08-07 | Warnings, Adverse reactions | 905395 FD171B778Y |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | A-S Medication Solutions | a8194ac4-02d5-4aa1-b4e4-a3759f6f64b5 | 2024-08-07 | Warnings, Adverse reactions | 905395 FD171B778Y |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 3b61d1b0-c699-67a8-e054-00144ff88e88 | 2024-07-16 | Warnings, Adverse reactions | ANDA040901 905199 FD171B778Y |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 4b7d3378-86f8-0a5f-e054-00144ff8d46c | 2024-07-15 | Warnings, Adverse reactions | ANDA040901 905395 FD171B778Y |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.