temazepam
- Product NDC
- 55289-660
- 11-digit product format
- 552890660
- Labeler code
- 55289
- Product ID
- 55289-660_419b1d3a-0d95-2e95-e063-6294a90a2123
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- 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 |
|---|
| 55289-660-01 | temazepam | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | | 23 |
| 55289-660-30 | temazepam | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 23 |
| 55289-660-60 | temazepam | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | | 23 |
| 55289-660-82 | temazepam | 500 in 1 BOTTLE, PLASTIC | CAPSULE | 500 | | 23 |
| 55289-660-90 | temazepam | 90 in 1 BOTTLE, PLASTIC | CAPSULE | 90 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55289-660 | TEMAZEPAM CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 22 | Current NDC, Legacy NDC, 5 package rows | 20241012_62379cd5-a314-43eb-a1ee-33997623bfa3.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 |
|---|
| 55289-660-01 | 55289066001 | 100 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-01) | 100 capsule | 2016-01-21 | 0000-00-00 | No | No | Current |
| 55289-660-30 | 55289066030 | 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-30) | 30 capsule | 2016-01-21 | 0000-00-00 | No | No | Current |
| 55289-660-60 | 55289066060 | 60 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-60) | 60 capsule | 2016-01-21 | 0000-00-00 | No | No | Current |
| 55289-660-82 | 55289066082 | 500 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-82) | 500 capsule | 2020-04-20 | 0000-00-00 | No | No | Current |
| 55289-660-90 | 55289066090 | 90 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-90) | 90 capsule | 2016-01-21 | 0000-00-00 | No | No | Current |