temazepam
- Product NDC
- 50268-780
- 11-digit product format
- 502680780
- Labeler code
- 50268
- Product ID
- 50268-780_2b4d448a-1ee3-fe11-e063-6394a90a2537
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA071457
- Marketing category
- ANDA
- Marketing start
- 2023-10-19
- 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 | 198241, 198242 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-780-11 | temazepam | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 3 |
| 50268-780-13 | temazepam | 30 in 1 BOX | CAPSULE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50268-780 | TEMAZEPAM CAPSULE [AVPAK] | 3 | Current NDC, 2 package rows | 20250112_08183adb-af12-fcb2-e063-6394a90afea4.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 |
|---|
| 50268-780-11 | 50268078011 | 1 in 1 BLISTER PACK | | | | | Historical |
| 50268-780-13 | 50268078013 | 30 BLISTER PACK in 1 BOX (50268-780-13) / 1 CAPSULE in 1 BLISTER PACK (50268-780-11) | 30 blister pack | 2023-10-19 | No | No | Current |