Temazepam
- Product NDC
- 80425-0191
- 11-digit product format
- 804250191
- Labeler code
- 80425
- Product ID
- 80425-0191_2a99a670-af37-299d-e063-6294a90a05d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA071456
- Marketing category
- ANDA
- Marketing start
- 2022-06-14
- Substance
- TEMAZEPAM
- Active strength
- 15 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| CHB1QD2QSS | TEMAZEPAM | 846-50-4 | TEMAZEPAM |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0191-1 | 80425019101 | 20 CAPSULE in 1 BOTTLE (80425-0191-1) | 20 capsule | 2024-02-17 | No | No | Historical |
| 80425-0191-2 | 80425019102 | 30 CAPSULE in 1 BOTTLE (80425-0191-2) | 30 capsule | 2023-03-30 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Temazepam Capsules | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 5 |