Temazepam
- Product NDC
- 65162-556
- 11-digit product format
- 651620556
- Labeler code
- 65162
- Product ID
- 65162-556_20d2675f-af6d-480c-9152-6f722fb1ea22
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA203482
- Marketing category
- ANDA
- Marketing start
- 2016-05-23
- Substance
- TEMAZEPAM
- Active strength
- 15 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Temazepam
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TEMAZEPAM | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CHB1QD2QSS |
| Rxcui | 198241, 198242, 198243, 485489 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-556-03 | Temazepam | 30 in 1 BOTTLE | CAPSULE | 30 | | 23 |
| 65162-556-10 | Temazepam | 100 in 1 BOTTLE | CAPSULE | 100 | | 23 |
| 65162-556-11 | Temazepam | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 23 |
| 65162-556-50 | Temazepam | 500 in 1 BOTTLE | CAPSULE | 500 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-556 | TEMAZEPAM CAPSULE [AMNEAL PHARMACEUTICALS LLC] | 20 | Current NDC, Legacy NDC, 4 package rows | 20241031_be68c6e0-17ad-40fe-9bc1-58abe24b53f6.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 |
|---|
| 65162-556-03 | 65162055603 | 30 CAPSULE in 1 BOTTLE (65162-556-03) | 30 capsule | 2016-05-23 | 0000-00-00 | No | No | Current |
| 65162-556-10 | 65162055610 | 100 CAPSULE in 1 BOTTLE (65162-556-10) | 100 capsule | 2016-05-23 | 0000-00-00 | No | No | Current |
| 65162-556-11 | 65162055611 | 1000 CAPSULE in 1 BOTTLE (65162-556-11) | 1000 capsule | 2016-05-23 | 0000-00-00 | No | No | Current |
| 65162-556-50 | 65162055650 | 500 CAPSULE in 1 BOTTLE (65162-556-50) | 500 capsule | 2016-05-23 | 0000-00-00 | No | No | Current |