Temazepam
- Product NDC
- 46708-381
- 11-digit product format
- 467080381
- Labeler code
- 46708
- Product ID
- 46708-381_387adad5-eb5e-429f-bc8a-b9ace387bc3f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA211542
- Marketing category
- ANDA
- Marketing start
- 2018-11-27
- Substance
- TEMAZEPAM
- Active strength
- 22.5 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 | 22.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CHB1QD2QSS |
| Rxcui | 198241, 198242, 198243, 485489 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-381-30 | Temazepam | 30 in 1 BOTTLE | CAPSULE | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-381 | TEMAZEPAM CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED] | 4 | Current NDC, Legacy NDC, 1 package rows | 20230129_db839409-8e95-41d3-804e-dcd5d11f4934.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 46708-381-30 | 46708038130 | 30 CAPSULE in 1 BOTTLE (46708-381-30) | 30 capsule | 2018-11-27 | 0000-00-00 | No | No | Current |