Temazepam
- Product NDC
- 0904-6436
- 11-digit product format
- 009046436
- Labeler code
- 0904
- Product ID
- 0904-6436_03705b1b-d68d-44b6-9ac4-5bacb01dacf7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA071457
- Marketing category
- ANDA
- Marketing start
- 2015-03-25
- Substance
- TEMAZEPAM
- Active strength
- 7.5 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 | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CHB1QD2QSS |
| Rxcui | 198243 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-6436-04 | Temazepam | 30 in 1 CARTON | CAPSULE | 30 | | 9 |
| 0904-6436-04 | Temazepam | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 9 |
| 0904-6436-60 | Temazepam | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | | 9 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6436 | TEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS] | 9 | Current NDC, Legacy NDC, 3 package rows | 20250316_2c4f564d-d349-4f9b-b3f4-f3f0d9706a4d.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 |
|---|
| 0904-6436-04 | 00904643604 | 30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK | 30 blister pack | 2015-03-25 | 0000-00-00 | No | No | Current |
| 0904-6436-60 | 00904643660 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0904-6436-60) | 100 capsule | 2015-03-25 | 0000-00-00 | No | No | Current |