Hydralazine Hydrochloride
- Product NDC
- 62135-579
- 11-digit product format
- 621350579
- Labeler code
- 62135
- Product ID
- 62135-579_459c0193-3a85-878d-e063-6294a90afc31
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA086242
- Marketing category
- ANDA
- Marketing start
- 2007-04-06
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 10 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 Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDRALAZINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FD171B778Y |
| Rxcui | 905199, 905222, 905225, 905395 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-579-12 | Hydralazine Hydrochloride | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-579 | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [CHARTWELL RX, LLC] | 1 | Current NDC, 1 package rows | 20230517_0c7f9bd0-6c0a-4521-b77a-3582faa96874.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-579-12 | 62135057912 | 120 TABLET, FILM COATED in 1 BOTTLE (62135-579-12) | 2023-05-09 | No | No | Current |