temazepam
- Product NDC
- 43353-260
- 11-digit product format
- 433530260
- Labeler code
- 43353
- Product ID
- 43353-260_ec1b0a54-5f93-45ed-bbbf-0bf3cd42ba73
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA071457
- Marketing category
- ANDA
- Marketing start
- 1987-04-21
- 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#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-260 | TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 4 | Current NDC, Legacy NDC, 6 package rows | 20240124_b2422ca0-2f06-419f-aa0e-88c556b62399.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 |
|---|
| 43353-260-15 | 43353026015 | 15 CAPSULE in 1 BOTTLE (43353-260-15) | 15 capsule | 2016-11-18 | 0000-00-00 | No | No | Current |
| 43353-260-20 | 43353026020 | 20 CAPSULE in 1 BOTTLE (43353-260-20) | 20 capsule | 2018-12-28 | | No | No | Current |
| 43353-260-28 | 43353026028 | 28 CAPSULE in 1 BOTTLE (43353-260-28) | 28 capsule | 2018-07-18 | | No | No | Current |
| 43353-260-30 | 43353026030 | 30 CAPSULE in 1 BOTTLE (43353-260-30) | 30 capsule | 2017-05-01 | 0000-00-00 | No | No | Current |
| 43353-260-53 | 43353026053 | 60 CAPSULE in 1 BOTTLE (43353-260-53) | 60 capsule | 2016-11-18 | 0000-00-00 | No | No | Current |
| 43353-260-60 | 43353026060 | 90 CAPSULE in 1 BOTTLE (43353-260-60) | 90 capsule | 2017-10-25 | | No | No | Current |