DIAZEPAM
- Product NDC
- 11534-199
- 11-digit product format
- 115340199
- Labeler code
- 11534
- Product ID
- 11534-199_e95b8ea6-9d51-4621-bb87-a365121b08bb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diazepam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sunrise Pharmaceutical, Inc.
- Application
- ANDA070464
- Marketing category
- ANDA
- Marketing start
- 2024-12-09
- Substance
- DIAZEPAM
- Active strength
- 10 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
- DIAZEPAM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIAZEPAM | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q3JTX2Q7TU |
| Rxcui | 197589, 197590, 197591 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 11534-199-01 | DIAZEPAM | 100 in 1 BOTTLE | TABLET | 100 | | 7 |
| 11534-199-03 | DIAZEPAM | 1000 in 1 BOTTLE | TABLET | 1000 | | 7 |
| 11534-199-04 | DIAZEPAM | 500 in 1 BOTTLE | TABLET | 500 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11534-199 | DIAZEPAM TABLET [SUNRISE PHARMACEUTICAL, INC.] | 7 | Current NDC, 3 package rows | 20241211_34ac0b9d-d4ad-4aaa-8bee-902365f4e9a8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 11534-199-01 | 11534019901 | 100 TABLET in 1 BOTTLE (11534-199-01) | 100 tablet | 2024-12-10 | No | No | Current |
| 11534-199-03 | 11534019903 | 1000 TABLET in 1 BOTTLE (11534-199-03) | 1000 tablet | 2024-12-10 | No | No | Current |
| 11534-199-04 | 11534019904 | 500 TABLET in 1 BOTTLE (11534-199-04) | 500 tablet | 2024-12-10 | No | No | Current |