temazepam
- Product NDC
- 63187-497
- 11-digit product format
- 631870497
- Labeler code
- 63187
- Product ID
- 63187-497_f2a9b002-a1ee-49e1-8477-0eb89fdbf1de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- 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 | 198242 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-497-00 | temazepam | 100 in 1 BOTTLE | CAPSULE | 100 | | 3 |
| 63187-497-30 | temazepam | 30 in 1 BOTTLE | CAPSULE | 30 | | 3 |
| 63187-497-60 | temazepam | 60 in 1 BOTTLE | CAPSULE | 60 | | 3 |
| 63187-497-90 | temazepam | 90 in 1 BOTTLE | CAPSULE | 90 | | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-497 | TEMAZEPAM CAPSULE [PROFICIENT RX LP] | 3 | Current NDC, Legacy NDC, 4 package rows | 20210114_5aaf8c99-cd58-47fc-8bf5-1039a6315ca5.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 |
|---|
| 63187-497-00 | 63187049700 | 100 CAPSULE in 1 BOTTLE (63187-497-00) | 100 capsule | 2019-01-01 | 0000-00-00 | No | No | Current |
| 63187-497-30 | 63187049730 | 30 CAPSULE in 1 BOTTLE (63187-497-30) | 30 capsule | 2019-01-01 | 0000-00-00 | No | No | Current |
| 63187-497-60 | 63187049760 | 60 CAPSULE in 1 BOTTLE (63187-497-60) | 60 capsule | 2019-01-01 | 0000-00-00 | No | No | Current |
| 63187-497-90 | 63187049790 | 90 CAPSULE in 1 BOTTLE (63187-497-90) | 90 capsule | 2019-01-01 | 0000-00-00 | No | No | Current |