HYDRALAZINE HYDROCHLORIDE
- Product NDC
- 23155-004
- 11-digit product format
- 231550004
- Labeler code
- 23155
- Product ID
- 23155-004_4b54be21-f54e-41f0-b799-0561c30e8d51
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydralazine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Application
- ANDA086242
- Marketing category
- ANDA
- Marketing start
- 2007-04-06
- Marketing end
- 0000-00-00
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 23155-004-01 | HYDRALAZINE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 17 |
| 23155-004-10 | HYDRALAZINE HYDROCHLORIDE | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDRALAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | FD171B778Y | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC] | 8 | |
| HYDRALAZINE | ACTIVE MOIETY | 26NAK24LS8 | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC] | 8 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC] | 8 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC] | 8 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC] | 8 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC] | 8 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC] | 8 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC] | 8 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC] | 8 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC] | 8 | |
| HYDRALAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | FD171B778Y | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| HYDRALAZINE | ACTIVE MOIETY | 26NAK24LS8 | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| HYDRALAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | FD171B778Y | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| HYDRALAZINE | ACTIVE MOIETY | 26NAK24LS8 | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 23155-004 | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] | 15 | Legacy NDC, 2 package rows | 20231130_a04eefaf-ba3c-448d-8ece-4aa9ab2e3508.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 23155-004-01 | 23155000401 | 100 TABLET, FILM COATED in 1 BOTTLE (23155-004-01) | 2007-04-06 | 0000-00-00 | No | No | Current |
| 23155-004-10 | 23155000410 | 1000 TABLET, FILM COATED in 1 BOTTLE (23155-004-10) | 2007-04-06 | 0000-00-00 | No | No | Current |