Temazepam
- Product NDC
- 53746-556
- 11-digit product format
- 537460556
- Labeler code
- 53746
- Product ID
- 53746-556_18d70b19-ff94-443e-8169-cb7e87895146
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA203482
- Marketing category
- ANDA
- Marketing start
- 2024-02-19
- 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, 198242 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53746-556-01 | Temazepam | 100 in 1 BOTTLE | CAPSULE | 100 | | 1 |
| 53746-556-05 | Temazepam | 500 in 1 BOTTLE | CAPSULE | 500 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-556 | TEMAZEPAM CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 1 | Current NDC, 2 package rows | 20240220_6248295e-8176-48f8-8e9d-bba6deacaf0d.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 |
|---|
| 53746-556-01 | 53746055601 | 100 CAPSULE in 1 BOTTLE (53746-556-01) | 100 capsule | 2024-02-19 | No | No | Current |
| 53746-556-05 | 53746055605 | 500 CAPSULE in 1 BOTTLE (53746-556-05) | 500 capsule | 2024-02-19 | No | No | Current |