Temazepam
- Product NDC
- 43547-611
- 11-digit product format
- 435470611
- Labeler code
- 43547
- Product ID
- 43547-611_5f04458d-b81c-47f8-ab06-3c47dffc5e4d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Solco Healthcare U.S., LLC
- Application
- ANDA201781
- Marketing category
- ANDA
- Marketing start
- 2023-01-05
- Substance
- TEMAZEPAM
- Active strength
- 7.5 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 | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CHB1QD2QSS |
| Rxcui | 198241, 198242, 198243, 485489 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43547-611-10 | Temazepam | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43547-611 | TEMAZEPAM CAPSULE [SOLCO HEALTHCARE U.S., LLC] | 6 | Current NDC, Legacy NDC, 1 package rows | 20240929_3ce42f0e-821e-4c9a-8f6b-60621628fd4b.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 |
|---|
| 43547-611-10 | 43547061110 | 100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10) | 100 capsule | 2023-01-05 | 0000-00-00 | No | No | Current |