Temazepam
- Product NDC
- 68071-4083
- 11-digit product format
- 680714083
- Labeler code
- 68071
- Product ID
- 68071-4083_1d8e1fca-6862-7c08-e063-6394a90a08b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temazepam CIV
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA071620
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- Substance
- TEMAZEPAM
- Active strength
- 30 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 | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CHB1QD2QSS |
| Rxcui | 198242 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-4083-3 | 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 |
|---|
| 68071-4083 | TEMAZEPAM (TEMAZEPAM CIV) CAPSULE [NUCARE PHARMACEUTICALS,INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240727_617d1957-c414-7f34-e053-2a91aa0a3fe0.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 |
|---|
| 68071-4083-3 | 68071408303 | 30 CAPSULE in 1 BOTTLE (68071-4083-3) | 30 capsule | 2017-12-29 | 0000-00-00 | No | No | Current |