temazepam
- Product NDC
- 68788-8081
- 11-digit product format
- 687888081
- Labeler code
- 68788
- Product ID
- 68788-8081_8641609a-63b2-4fca-9f15-3334e97729f8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA071457
- Marketing category
- ANDA
- Marketing start
- 2021-10-05
- Substance
- TEMAZEPAM
- Active strength
- 30 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- temazepam
- Listing expiration
- 2027-12-31
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 |
|---|
| 68788-8081-3 | 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 |
|---|
| 68788-8081 | TEMAZEPAM CAPSULE [PREFERRED PHARMACEUTICALS INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240820_7e3fd8fe-fb8a-4577-b540-0e3fefe63627.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 |
|---|
| 68788-8081-3 | 68788808103 | 30 CAPSULE in 1 BOTTLE (68788-8081-3) | 30 capsule | 2021-10-05 | 0000-00-00 | No | No | Current |