TEMAZEPAM
- Product NDC
- 71610-004
- 11-digit product format
- 716100004
- Labeler code
- 71610
- Product ID
- 71610-004_a14e308f-61dd-47d4-bb0f-c69f9704c46b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- NDA018163
- Marketing category
- NDA
- Marketing start
- 2010-02-23
- 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 | 198243 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-004-30 | TEMAZEPAM | 30 in 1 BOTTLE | CAPSULE | 30 | | 3 |
| 71610-004-53 | TEMAZEPAM | 60 in 1 BOTTLE | CAPSULE | 60 | | 3 |
| 71610-004-60 | TEMAZEPAM | 90 in 1 BOTTLE | CAPSULE | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-004 | TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | Current NDC, Legacy NDC, 3 package rows | 20190409_405b1ee2-777b-4fd3-b4ee-bd2aacbe1dc1.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 |
|---|
| 71610-004-30 | 71610000430 | 30 CAPSULE in 1 BOTTLE (71610-004-30) | 30 capsule | 2017-08-14 | 0000-00-00 | No | No | Current |
| 71610-004-53 | 71610000453 | 60 CAPSULE in 1 BOTTLE (71610-004-53) | 60 capsule | 2017-11-22 | 0000-00-00 | No | No | Current |
| 71610-004-60 | 71610000460 | 90 CAPSULE in 1 BOTTLE (71610-004-60) | 90 capsule | 2017-11-22 | 0000-00-00 | No | No | Current |