Promethazine Hydrochloride
- Product NDC
- 80425-0265
- 11-digit product format
- 804250265
- Labeler code
- 80425
- Product ID
- 80425-0265_2a9bad62-b2fe-697c-e063-6294a90aa395
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA040596
- Marketing category
- ANDA
- Marketing start
- 2023-02-15
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| R61ZEH7I1I | PROMETHAZINE HYDROCHLORIDE | 58-33-3 | PROMETHAZINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0265-1 | 80425026501 | 20 TABLET in 1 BOTTLE (80425-0265-1) | 20 tablet | 2023-02-15 | No | No | Historical |