TEMAZEPAM
- Product NDC
- 72789-449
- 11-digit product format
- 727890449
- Labeler code
- 72789
- Product ID
- 72789-449_4124bd2d-cd9e-a9dc-e063-6294a90a25d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- NDA018163
- Marketing category
- NDA
- Marketing start
- 2010-02-23
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-449-30 | TEMAZEPAM | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-449 | TEMAZEPAM CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 16 | Current NDC, 1 package rows | 20241108_97afda58-4daf-4192-bd87-3ccbb000ee52.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 |
|---|
| 72789-449-30 | 72789044930 | 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-449-30) | 30 capsule | 2024-11-06 | No | No | Current |