Promethazine Hydrochloride
- Product NDC
- 76420-692
- 11-digit product format
- 764200692
- Labeler code
- 76420
- Product ID
- 76420-692_1244caf6-4af2-dd22-e063-6294a90a81bd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA040596
- Marketing category
- ANDA
- Marketing start
- 2005-12-14
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 50 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 |
|---|
| 76420-692-01 | 76420069201 | 100 TABLET in 1 BOTTLE (76420-692-01) | 100 tablet | 2024-02-26 | No | No | Historical |
| 76420-692-30 | 76420069230 | 30 TABLET in 1 BOTTLE (76420-692-30) | 30 tablet | 2024-02-26 | No | No | Historical |
| 76420-692-60 | 76420069260 | 60 TABLET in 1 BOTTLE (76420-692-60) | 60 tablet | 2024-02-26 | No | No | Historical |
| 76420-692-90 | 76420069290 | 90 TABLET in 1 BOTTLE (76420-692-90) | 90 tablet | 2024-02-26 | No | No | Historical |