Temazepam
- Product NDC
- 62332-379
- 11-digit product format
- 623320379
- Labeler code
- 62332
- Product ID
- 62332-379_f6347a33-09dd-4938-92eb-4bcc48a31cfa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA211542
- Marketing category
- ANDA
- Marketing start
- 2018-11-27
- 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 |
|---|
| 62332-379-30 | Temazepam | 30 in 1 BOTTLE | CAPSULE | 30 | | 10 |
| 62332-379-31 | Temazepam | 100 in 1 BOTTLE | CAPSULE | 100 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-379 | TEMAZEPAM CAPSULE [ALEMBIC PHARMACEUTICALS INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20230428_93b1be7f-ec41-46bb-a258-56cb459e2c92.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 |
|---|
| 62332-379-30 | 62332037930 | 30 CAPSULE in 1 BOTTLE (62332-379-30) | 30 capsule | 2018-11-27 | 0000-00-00 | No | No | Current |
| 62332-379-31 | 62332037931 | 100 CAPSULE in 1 BOTTLE (62332-379-31) | 100 capsule | 2018-11-27 | 0000-00-00 | No | No | Current |