Hydralazine Hydrochloride
- Product NDC
- 63187-901
- 11-digit product format
- 631870901
- Labeler code
- 63187
- Product ID
- 63187-901_8abc5903-cbd2-436d-b229-4e76d3726e09
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA086242
- Marketing category
- ANDA
- Marketing start
- 2007-04-06
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 25 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FD171B778Y |
| Rxcui | 905225 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-901-30 | Hydralazine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 63187-901-60 | Hydralazine Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
| 63187-901-90 | Hydralazine Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-901 | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] | 4 | Current NDC, Legacy NDC, 3 package rows | 20200923_63f388e0-9f3d-4902-990c-9a105aa098ad.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 |
|---|
| 63187-901-30 | 63187090130 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-901-30) | 2017-09-01 | 0000-00-00 | No | No | Current |
| 63187-901-60 | 63187090160 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-901-60) | 2017-09-01 | 0000-00-00 | No | No | Current |
| 63187-901-90 | 63187090190 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-901-90) | 2017-09-01 | 0000-00-00 | No | No | Current |