temazepam
- Product NDC
- 55289-196
- 11-digit product format
- 552890196
- Labeler code
- 55289
- Product ID
- 55289-196_4199da42-51af-009d-e063-6394a90a906c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA071456
- Marketing category
- ANDA
- Marketing start
- 1987-04-21
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55289-196-01 | temazepam | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | | 26 |
| 55289-196-14 | temazepam | 14 in 1 BOTTLE, PLASTIC | CAPSULE | 14 | | 26 |
| 55289-196-30 | temazepam | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 26 |
| 55289-196-60 | temazepam | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | | 26 |
| 55289-196-82 | temazepam | 500 in 1 BOTTLE, PLASTIC | CAPSULE | 500 | | 26 |
| 55289-196-90 | temazepam | 90 in 1 BOTTLE, PLASTIC | CAPSULE | 90 | | 26 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55289-196 | TEMAZEPAM CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 25 | Current NDC, Legacy NDC, 6 package rows | 20241115_45ef5e9c-f381-48d3-895d-e1d29be856ac.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 |
|---|
| 55289-196-01 | 55289019601 | 100 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-01) | 100 capsule | 2016-02-05 | 0000-00-00 | No | No | Current |
| 55289-196-14 | 55289019614 | 14 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-14) | 14 capsule | 2016-02-05 | 0000-00-00 | No | No | Current |
| 55289-196-30 | 55289019630 | 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-30) | 30 capsule | 2016-02-05 | 0000-00-00 | No | No | Current |
| 55289-196-60 | 55289019660 | 60 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-60) | 60 capsule | 2016-02-05 | 0000-00-00 | No | No | Current |
| 55289-196-82 | 55289019682 | 500 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-82) | 500 capsule | 2020-04-20 | 0000-00-00 | No | No | Current |
| 55289-196-90 | 55289019690 | 90 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-90) | 90 capsule | 2018-12-13 | 0000-00-00 | No | No | Current |