Temazepam
- Product NDC
- 67544-136
- 11-digit product format
- 675440136
- Labeler code
- 67544
- Product ID
- 67544-136_6d75ac66-4a65-487b-a938-7414907c2632
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA071638
- Marketing category
- ANDA
- Marketing start
- 1987-08-03
- Substance
- TEMAZEPAM
- Active strength
- 15 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 | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CHB1QD2QSS |
| Rxcui | 198241, 198242 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67544-136-10 | Temazepam | 10 in 1 BOTTLE, PLASTIC | CAPSULE | 10 | | 2 |
| 67544-136-14 | Temazepam | 14 in 1 BOTTLE, PLASTIC | CAPSULE | 14 | | 2 |
| 67544-136-15 | Temazepam | 15 in 1 BOTTLE, PLASTIC | CAPSULE | 15 | | 2 |
| 67544-136-20 | Temazepam | 20 in 1 BOTTLE, PLASTIC | CAPSULE | 20 | | 2 |
| 67544-136-28 | Temazepam | 28 in 1 BOTTLE, PLASTIC | CAPSULE | 28 | | 2 |
| 67544-136-30 | Temazepam | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 2 |
| 67544-136-45 | Temazepam | 45 in 1 BOTTLE, PLASTIC | CAPSULE | 45 | | 2 |
| 67544-136-53 | Temazepam | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | | 2 |
| 67544-136-60 | Temazepam | 90 in 1 BOTTLE, PLASTIC | CAPSULE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67544-136 | TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Current NDC, Legacy NDC, 9 package rows | 20190531_2461dfbd-5704-42f4-bde7-d1461811d898.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 |
|---|
| 67544-136-10 | 67544013610 | 10 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-10) | 10 capsule | 2004-08-26 | 0000-00-00 | No | No | Current |
| 67544-136-14 | 67544013614 | 14 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-14) | 14 capsule | 2004-08-26 | 0000-00-00 | No | No | Current |
| 67544-136-15 | 67544013615 | 15 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-15) | 15 capsule | 2004-09-16 | 0000-00-00 | No | No | Current |
| 67544-136-20 | 67544013620 | 20 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-20) | 20 capsule | 2004-09-01 | 0000-00-00 | No | No | Current |
| 67544-136-28 | 67544013628 | 28 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-28) | 28 capsule | 2009-08-30 | 0000-00-00 | No | No | Current |
| 67544-136-30 | 67544013630 | 30 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-30) | 30 capsule | 2004-10-16 | 0000-00-00 | No | No | Current |
| 67544-136-45 | 67544013645 | 45 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-45) | 45 capsule | 2004-09-01 | 0000-00-00 | No | No | Current |
| 67544-136-53 | 67544013653 | 60 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-53) | 60 capsule | 2004-10-16 | 0000-00-00 | No | No | Current |
| 67544-136-60 | 67544013660 | 90 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-60) | 90 capsule | 2004-12-08 | 0000-00-00 | No | No | Current |