Hydralazine Hydrochloride
- Product NDC
- 68788-8087
- 11-digit product format
- 687888087
- Labeler code
- 68788
- Product ID
- 68788-8087_4dea31eb-3662-41d5-aa2a-292b5a0ae9dd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA040901
- Marketing category
- ANDA
- Marketing start
- 2021-10-05
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydralazine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDRALAZINE HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FD171B778Y |
| Rxcui | 905222 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8087-1 | Hydralazine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8087 | HYDRALAZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240517_438479d0-ff61-4008-a0fc-1ee44b97cf7f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-8087-1 | 68788808701 | 100 TABLET in 1 BOTTLE (68788-8087-1) | 100 tablet | 2021-10-05 | 0000-00-00 | No | No | Current |