NDC 67787-309 - 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
- 67787-309
- Package NDCs from labels
- 67787-309-01, 67787-309-10
- Manufacturer
- InvaGen Pharmaceuticals, Inc.,
- Effective date
- 2008-12-22
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| HydrALAZINE Hydrochloride - InvaGen Pharmaceuticals, Inc., | InvaGen Pharmaceuticals, Inc., | 2008-12-22 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67787-309-01 | HydrALAZINE Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 67787-309-10 | HydrALAZINE Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Hydralazine Hydrochloride | ACTIVE INGREDIENT | FD171B778Y | HYDRALAZINE HYDROCHLORIDE TABLET [INVAGEN PHARMACEUTICALS, INC.,] | 1 | |
| Hydralazine | ACTIVE MOIETY | 26NAK24LS8 | HYDRALAZINE HYDROCHLORIDE TABLET [INVAGEN PHARMACEUTICALS, INC.,] | 1 | |
| FD&C Yellow # 6 | INACTIVE INGREDIENT | HYDRALAZINE HYDROCHLORIDE TABLET [INVAGEN PHARMACEUTICALS, INC.,] | 1 | ||
| Lactose anhydrous | INACTIVE INGREDIENT | HYDRALAZINE HYDROCHLORIDE TABLET [INVAGEN PHARMACEUTICALS, INC.,] | 1 | ||
| Microcrystalline cellulose | INACTIVE INGREDIENT | OP1R32D61U | HYDRALAZINE HYDROCHLORIDE TABLET [INVAGEN PHARMACEUTICALS, INC.,] | 1 | |
| Sodium starch glycolate | INACTIVE INGREDIENT | HYDRALAZINE HYDROCHLORIDE TABLET [INVAGEN PHARMACEUTICALS, INC.,] | 1 | ||
| Stearic acid | INACTIVE INGREDIENT | 4ELV7Z65AP | HYDRALAZINE HYDROCHLORIDE TABLET [INVAGEN PHARMACEUTICALS, INC.,] | 1 |
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 | A-S Medication Solutions | f16f1d87-f9e6-4555-9baf-26ff17cb1d28 | 2025-12-05 | Warnings, Adverse reactions | 905225 905395 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Cardinal Health 107, LLC | 336b11da-e592-4386-921f-3c136d754f2a | 2025-11-06 | Warnings, Adverse reactions | 905225 905395 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Coupler LLC | 41c019e3-7b07-5f12-e063-6294a90a5365 | 2025-10-22 | Warnings, Adverse reactions | 905199 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Mylan Institutional Inc. | 493a8b7e-5bb1-4db2-91a7-77ed87864131 | 2025-07-22 | Warnings, Adverse reactions | 905225 905199 905395 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Proficient Rx LP | 024ac6b8-5ce0-4435-9b11-b1806c511d7b | 2025-07-01 | Warnings, Adverse reactions | 905225 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | a79ddc89-546b-4808-879d-c0f592141636 | 2025-03-31 | Warnings, Adverse reactions | 905199 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 90c18c55-3045-4a10-a2bb-012e4a5e1564 | 2025-03-25 | Warnings, Adverse reactions | 905395 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | 5da36930-d3da-4b5c-9e22-2b141bc01a9c | 2025-03-13 | Warnings, Adverse reactions | 905225 905199 905395 905222 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Coupler LLC | 2e9688ef-781c-aead-e063-6294a90a7bca | 2025-02-20 | Warnings, Adverse reactions | 905199 |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | Coupler LLC | 2df51a19-a39a-0ec8-e063-6394a90a147c | 2025-02-12 | Warnings, Adverse reactions | 905395 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Proficient Rx LP | 775e99c4-e18d-4648-a0e3-8709950249ff | 2025-02-01 | Warnings, Adverse reactions | 905222 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 7ae650f7-a481-4637-a9a2-9bda43a5a288 | 2024-12-24 | Warnings, Adverse reactions | 905225 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | a862321d-ebc1-7676-e053-2995a90a5861 | 2024-12-17 | Warnings, Adverse reactions | 905222 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | ff2c4d1e-33ee-40d7-955b-d736f0559f39 | 2024-12-03 | Warnings, Adverse reactions | 905225 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 10f3e76e-9bba-4151-89fb-90d823a0a68c | 2024-11-08 | Warnings, Adverse reactions | 905225 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | American Health Packaging | 2e82655e-8435-46fa-b734-8e7c6e803453 | 2024-09-23 | Warnings, Adverse reactions | 905225 905199 905395 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Macleods Pharmaceuticals Limited | f9f56326-6d72-47d3-89ac-3625b8a6d713 | 2024-09-06 | Warnings, Adverse reactions | 905225 905199 905395 905222 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | f07abdec-6d94-45b6-be1b-10a898ea28c2 | 2024-08-12 | Warnings, Adverse reactions | 905222 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | A-S Medication Solutions | 8ade1ffe-3738-4aa1-b9c7-59f7290600b9 | 2024-08-07 | Warnings, Adverse reactions | 905395 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | A-S Medication Solutions | a8194ac4-02d5-4aa1-b4e4-a3759f6f64b5 | 2024-08-07 | Warnings, Adverse reactions | 905395 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.