NDC 67787-311 - 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
- 67787-311
- Package NDCs from labels
- 67787-311-01, 67787-311-10
- 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 |
|---|---|---|---|---|---|---|
| 67787-311-01 | HydrALAZINE Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 67787-311-10 | 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 | NuCare Pharmaceuticals, Inc. | 3b61d1b0-c699-67a8-e054-00144ff88e88 | 2024-07-16 | Warnings, Adverse reactions | 905199 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 4b7d3378-86f8-0a5f-e054-00144ff8d46c | 2024-07-15 | Warnings, Adverse reactions | 905395 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Glenmark Pharmaceuticals Inc., USA | 37ba0233-ed75-498a-a067-6220da573653 | 2024-05-24 | Warnings, Adverse reactions | 905225 905199 905395 905222 |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | Modavar Pharmaceuticals LLC | a456bc34-0c79-44f4-9119-50028a978f5f | 2024-05-14 | Warnings, Adverse reactions | 905225 905395 905222 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | c2638ae6-a210-490f-8389-bbed6a3229c5 | 2024-04-03 | Warnings, Adverse reactions | 905225 905395 905222 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 8224aa3d-b1b9-40df-93fd-a91c6a158898 | 2024-02-20 | Warnings, Adverse reactions | 905225 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | bc37cf50-b18d-467e-bf67-3270faa8332e | 2024-02-05 | Warnings, Adverse reactions | 905222 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | d5b0165e-9823-470a-8ed0-5c4c8722369d | 2024-02-05 | Warnings, Adverse reactions | 905395 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 4d1594dc-376b-44bd-8c0e-5de731dfb7f9 | 2024-02-02 | Warnings, Adverse reactions | 905199 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 18dd864f-1e27-4c98-8f21-eaded77a3ed6 | 2024-01-11 | Warnings, Adverse reactions | 905395 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | e6d4b15e-1407-4783-94e4-9971dea68221 | 2024-01-11 | Warnings, Adverse reactions | 905199 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 36499d4b-bcaf-4b49-aa2a-10c3e34550d0 | 2024-01-11 | Warnings, Adverse reactions | 905225 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 4985994c-23ab-4409-bab6-5a17db767f13 | 2024-01-11 | Warnings, Adverse reactions | 905199 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 162a0c00-4db8-4f8d-9686-be2f8449abd8 | 2024-01-11 | Warnings, Adverse reactions | 905222 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 914d5b62-6f9b-4665-8562-689367c36230 | 2023-12-14 | Warnings, Adverse reactions | 905199 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | d4509f69-e60e-4440-957b-5c2714480335 | 2023-11-27 | Warnings, Adverse reactions | 905222 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | A-S Medication Solutions | e617023e-b060-4db9-a97e-e2b11a37901e | 2023-08-28 | Warnings, Adverse reactions | 905395 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 62475f78-5410-43c2-a11d-54a8363c3ae1 | 2023-07-25 | Warnings, Adverse reactions | 905395 |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | Cadila Pharmaceuticals Limited | 3a7562a8-2f67-4411-ac4a-ab7924193e82 | 2022-12-29 | Warnings, Adverse reactions | 905225 905395 905222 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Radha Pharmaceuticals, Inc. | 149fa857-30ad-451d-b6e2-0000483ccc97 | 2021-03-12 | Warnings, Adverse reactions | 905225 905199 905395 905222 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.