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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Temazepam
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TEMAZEPAM | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CHB1QD2QSS |
| Rxcui | 198241 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0191-1 | Temazepam | 20 in 1 BOTTLE | CAPSULE | 20 | | 5 |
| 80425-0191-2 | Temazepam | 30 in 1 BOTTLE | CAPSULE | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0191 | TEMAZEPAM CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250101_d83e14ae-9823-e57b-e053-2a95a90a8524.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |
| 80425-0191-2 | 80425019102 | 30 CAPSULE in 1 BOTTLE (80425-0191-2) | 30 capsule | 2023-03-30 | No | No | Current |