Promethazine Hydrochloride
- Product NDC
- 52584-495
- 11-digit product format
- 525840495
- Labeler code
- 52584
- Product ID
- 52584-495_6e36766a-ff5b-4135-9e9d-c01c3962c1d0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- General Injectables & Vaccines, Inc
- Application
- ANDA083312
- Marketing category
- ANDA
- Marketing start
- 2010-08-01
- Marketing end
- 2024-06-30
- 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52584-495-31 | 52584049531 | 1 AMPULE in 1 BAG (52584-495-31) > 1 mL in 1 AMPULE | 1 ampule | 2010-08-01 | 0000-00-00 | No | No | Current |