Temazepam
- Product NDC
- 71610-986
- 11-digit product format
- 716100986
- Labeler code
- 71610
- Product ID
- 71610-986_4a66f24a-2f26-dd9a-e063-6394a90a0e4d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA211542
- Marketing category
- ANDA
- Marketing start
- 2018-11-23
- Substance
- TEMAZEPAM
- Active strength
- 30 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 | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CHB1QD2QSS |
| Rxcui | 198242 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-986-28 | Temazepam | 28 in 1 BOTTLE | CAPSULE | 28 | | 2 |
| 71610-986-30 | Temazepam | 30 in 1 BOTTLE | CAPSULE | 30 | | 2 |
| 71610-986-60 | Temazepam | 90 in 1 BOTTLE | CAPSULE | 90 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-986-28 | 71610098628 | 28 CAPSULE in 1 BOTTLE (71610-986-28) | 28 capsule | 2026-02-09 | No | No | Current |
| 71610-986-30 | 71610098630 | 30 CAPSULE in 1 BOTTLE (71610-986-30) | 30 capsule | 2026-02-09 | No | No | Current |
| 71610-986-60 | 71610098660 | 90 CAPSULE in 1 BOTTLE (71610-986-60) | 90 capsule | 2026-02-09 | No | No | Current |