PROMETHAZINE HYDROCHLORIDE
- Product NDC
- 52584-078
- 11-digit product format
- 525840078
- Labeler code
- 52584
- Product ID
- 52584-078_362f4f7d-94de-488a-bd55-339812f1f107
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PROMETHAZINE HYDROCHLORIDE
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- General Injectables and Vaccines, Inc.
- Application
- ANDA083312
- Marketing category
- ANDA
- Marketing start
- 2018-07-03
- Marketing end
- 2024-04-30
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 mg/mL
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS]
- 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 |
|---|
| 52584-078-21 | 52584007821 | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-078-21) > 1 mL in 1 VIAL, SINGLE-DOSE | 2018-07-03 | 2024-04-30 | No | No | Current |