HYDRALAZINE HYDROCHLORIDE
- Product NDC
- 52584-112
- 11-digit product format
- 525840112
- Labeler code
- 52584
- Product ID
- 52584-112_69b6aad8-5ee1-4959-9678-c5358adece76
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydralazine hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- General Injectables and Vaccines, Inc.
- Application
- ANDA040730
- Marketing category
- ANDA
- Marketing start
- 2021-02-15
- Marketing end
- 2023-02-28
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52584-112-01 | 52584011201 | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-112-01) > 1 mL in 1 VIAL, SINGLE-DOSE | 2021-02-15 | 2023-02-28 | No | No | Current |