Hydralazine Hydrochloride
- Product NDC
- 0904-6440
- 11-digit product format
- 009046440
- Labeler code
- 0904
- Product ID
- 0904-6440_512fa4b6-6ff4-4eb6-a4e5-8a7d55fda758
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA086242
- Marketing category
- ANDA
- Marketing start
- 2015-05-14
- Marketing end
- 0000-00-00
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 10 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 Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDRALAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | FD171B778Y | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | |
| HYDRALAZINE | ACTIVE MOIETY | 26NAK24LS8 | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6440 | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 9 | Legacy NDC | 20240629_7dc7c11b-ac51-4db3-ac6a-708c676a8859.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-6440-61 | 00904644061 | 100 BLISTER PACK in 1 CARTON (0904-6440-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2015-05-14 | 0000-00-00 | No | No | Current |