NDC 67787-312 - 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
- 67787-312
- Package NDCs from labels
- 67787-312-01, 67787-312-05
- 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 |
|---|---|---|---|---|---|---|
| 67787-312-01 | HydrALAZINE Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 67787-312-05 | HydrALAZINE Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | 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 | REMEDYREPACK INC. | 51c293c1-70e7-48c7-8af1-a8b74312ed56 | 2026-09-08 | Warnings, Adverse reactions | 905222 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | REMEDYREPACK INC. | 6c40d818-77a9-492c-b9b6-d8a0fe8d6736 | 2026-08-27 | Warnings, Adverse reactions | 905225 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | d2d98842-ff32-4a61-94e0-60e06919948f | 2026-08-14 | Warnings, Adverse reactions | 905225 905222 |
| HydrALAZINE Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Coupler LLC | 58773e8c-b6bc-6bc6-e063-6294a90adc26 | 2026-08-07 | Warnings, Adverse reactions | 905395 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Cardinal Health 107, LLC | db7500f3-f8a6-46b1-bb64-9727617a9643 | 2026-07-30 | Warnings, Adverse reactions | 905225 905395 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Major Pharmaceuticals | b6ccd35e-f69c-4eef-a456-905e030ae911 | 2026-07-15 | Warnings, Adverse reactions | 905225 905199 905395 905222 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Northwind Health Company, LLC | 1275dd50-d97f-2e8f-e063-6394a90a4a67 | 2026-06-22 | Warnings, Adverse reactions | 905225 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | REMEDYREPACK INC. | d61ffa06-8138-4a1d-9530-095a80d9c9ce | 2026-06-12 | Warnings, Adverse reactions | 905395 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | REMEDYREPACK INC. | a70d20d6-23f0-477e-915c-678a86782175 | 2026-06-12 | Warnings, Adverse reactions | 905199 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | REMEDYREPACK INC. | 0d65e146-83e5-427f-ac06-04c0d8e72cea | 2026-06-09 | Warnings, Adverse reactions | 905225 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Cardinal Health 107, LLC | a1066707-2391-4918-8ded-600c017fde48 | 2026-05-18 | Warnings, Adverse reactions | 905225 905395 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | 438479d0-ff61-4008-a0fc-1ee44b97cf7f | 2026-05-07 | Warnings, Adverse reactions | 905222 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 669532c9-ba15-4f4b-95a8-13782deb3521 | 2026-04-03 | Warnings, Adverse reactions | 905225 905199 905395 905222 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Safecor Health, LLC | 66c5eaa4-a51a-464b-98ad-f094f32876dd | 2026-03-11 | Warnings, Adverse reactions | 905225 905199 905395 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Coupler LLC | 4aa1b3e8-9389-fe2c-e063-6294a90a7fb9 | 2026-02-12 | Warnings, Adverse reactions | 905225 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | REMEDYREPACK INC. | 89afc8ef-27c4-489a-81de-3f8f65f6bbb8 | 2026-02-09 | Warnings, Adverse reactions | 905225 |
| HydrALAZINE Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Strides Pharma Science Limited | b3d1786d-c3ff-42f1-a09f-37a9c9021e5a | 2026-02-02 | Warnings, Adverse reactions | 905225 905199 905395 905222 |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | e9450e82-329f-4fd8-a0b3-3e8e22715965 | 2026-01-07 | Warnings, Adverse reactions | 905395 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Chartwell RX, LLC | 0c7f9bd0-6c0a-4521-b77a-3582faa96874 | 2025-12-10 | Warnings, Adverse reactions | 905225 905199 905395 905222 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | A-S Medication Solutions | 7253aaa0-e272-499f-9bfa-304e9556a8fb | 2025-12-05 | Warnings, Adverse reactions | 905395 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.