Temazepam
- Product NDC
- 68788-8493
- 11-digit product format
- 687888493
- Labeler code
- 68788
- Product ID
- 68788-8493_b38abef7-ba46-4b82-9712-9fe348e517d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA211542
- Marketing category
- ANDA
- Marketing start
- 2023-07-24
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8493-3 | Temazepam | 30 in 1 BOTTLE | CAPSULE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8493 | TEMAZEPAM CAPSULE [PREFERRED PHARMACEUTICALS INC.] | 2 | Current NDC, 1 package rows | 20240820_cbe5bd6a-f36a-4557-82d8-ef4e49d310e9.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 |
|---|
| 68788-8493-3 | 68788849303 | 30 CAPSULE in 1 BOTTLE (68788-8493-3) | 30 capsule | 2023-07-24 | No | No | Historical |