temazepam
- Product NDC
- 70518-0647
- 11-digit product format
- 705180647
- Labeler code
- 70518
- Product ID
- 70518-0647_4d7512dc-aa35-33ea-e063-6394a90a28f7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA071456
- Marketing category
- ANDA
- Marketing start
- 2017-07-28
- Substance
- TEMAZEPAM
- Active strength
- 15 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 | 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 |
|---|
| 70518-0647-0 | temazepam | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 16 |
| 70518-0647-1 | temazepam | 100 in 1 BOX | CAPSULE | 100 | | 16 |
| 70518-0647-2 | temazepam | 1 in 1 POUCH | CAPSULE | 1 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-0647 | TEMAZEPAM CAPSULE [REMEDYREPACK INC.] | 13 | Current NDC, Legacy NDC, 3 package rows | 20250429_65857a9b-a225-4887-b0dc-58ab6d60f9d0.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 |
|---|
| 70518-0647-0 | 70518064700 | 30 CAPSULE in 1 BLISTER PACK (70518-0647-0) | 30 capsule | 2017-07-28 | No | No | Current |
| 70518-0647-1 | 70518064701 | 100 in 1 BOX | | | | | Historical |
| 70518-0647-2 | 70518064702 | 1 in 1 POUCH | | | | | Historical |