Hydralazine
- Product NDC
- 75834-128
- 11-digit product format
- 758340128
- Labeler code
- 75834
- Product ID
- 75834-128_379fe677-a8e7-4bfe-abcf-85283768c27b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDRALAZINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Nivagen Pharmaceuticals, Inc.
- Application
- ANDA203845
- Marketing category
- ANDA
- Marketing start
- 2017-02-15
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydralazine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDRALAZINE HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FD171B778Y |
| Rxcui | 905222, 905225, 905395 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 75834-128-00 | 2022-02-15 | C162847 | 48780-1 | 9d75b9cf-fe24-f424-e053-dadaa90a57ce | HYDRALAZINE HYDROCHLORIDE TABLETS, USP |
| 75834-128-01 | 2022-02-15 | C162847 | 48780-1 | 9d75b9cf-fe24-f424-e053-dadaa90a57ce | HYDRALAZINE HYDROCHLORIDE TABLETS, USP |
| 75834-128-00 | 2022-01-28 | C162847 | 48780-1 | 9d75b9cf-fe24-f424-e053-dadaa90a57ce | HYDRALAZINE HYDROCHLORIDE TABLETS, USP |
| 75834-128-01 | 2022-01-28 | C162847 | 48780-1 | 9d75b9cf-fe24-f424-e053-dadaa90a57ce | HYDRALAZINE HYDROCHLORIDE TABLETS, USP |
| 75834-128-00 | 2020-05-06 | C162847 | 48780-1 | 9d75b9cf-fe24-f424-e053-dadaa90a57ce | HYDRALAZINE HYDROCHLORIDE TABLETS, USP |
| 75834-128-01 | 2020-05-06 | C162847 | 48780-1 | 9d75b9cf-fe24-f424-e053-dadaa90a57ce | HYDRALAZINE HYDROCHLORIDE TABLETS, USP |
| 75834-128-00 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-fe24-f424-e053-dadaa90a57ce | HYDRALAZINE HYDROCHLORIDE TABLETS, USP |
| 75834-128-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-fe24-f424-e053-dadaa90a57ce | HYDRALAZINE HYDROCHLORIDE TABLETS, USP |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75834-128-00 | Hydralazine | 1000 in 1 BOTTLE | TABLET | 1000 | | 3 |
| 75834-128-01 | Hydralazine | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75834-128 | HYDRALAZINE (HYDRALAZINE HYDROCHLORIDE) TABLET [NIVAGEN PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20220216_1fd8cf42-66ae-4af5-a5ae-7c9679a0e532.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 |
|---|
| 75834-128-00 | 75834012800 | 1000 TABLET in 1 BOTTLE (75834-128-00) | 1000 tablet | 2017-02-15 | 0000-00-00 | No | No | Current |
| 75834-128-01 | 75834012801 | 100 TABLET in 1 BOTTLE (75834-128-01) | 100 tablet | 2017-02-15 | 0000-00-00 | No | No | Current |