Promethazine Hydrochloride
- Product NDC
- 71205-658
- 11-digit product format
- 712050658
- Labeler code
- 71205
- Product ID
- 71205-658_f274f5be-72ff-42e5-a4ba-8d1d957375b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA040596
- Marketing category
- ANDA
- Marketing start
- 2014-01-13
- 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 |
|---|
| 71205-658-10 | 71205065810 | 10 TABLET in 1 BOTTLE (71205-658-10) | 10 tablet | 2022-05-05 | No | No | Historical |
| 71205-658-12 | 71205065812 | 12 TABLET in 1 BOTTLE (71205-658-12) | 12 tablet | 2023-01-04 | No | No | Historical |
| 71205-658-20 | 71205065820 | 20 TABLET in 1 BOTTLE (71205-658-20) | 20 tablet | 2022-09-27 | No | No | Historical |
| 71205-658-30 | 71205065830 | 30 TABLET in 1 BOTTLE (71205-658-30) | 30 tablet | 2022-05-05 | No | No | Historical |
| 71205-658-60 | 71205065860 | 60 TABLET in 1 BOTTLE (71205-658-60) | 60 tablet | 2022-05-05 | No | No | Historical |
| 71205-658-90 | 71205065890 | 90 TABLET in 1 BOTTLE (71205-658-90) | 90 tablet | 2022-05-05 | No | No | Historical |