DIAZEPAM
- Product NDC
- 68071-3682
- 11-digit product format
- 680713682
- Labeler code
- 68071
- Product ID
- 68071-3682_2a3162ec-9701-d87d-e063-6394a90adbd3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DIAZEPAM
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA217843
- Marketing category
- ANDA
- Marketing start
- 2023-12-14
- Substance
- DIAZEPAM
- Active strength
- 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
- DIAZEPAM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIAZEPAM | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q3JTX2Q7TU |
| Rxcui | 197591 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3682-1 | DIAZEPAM | 10 in 1 BOTTLE | TABLET | 10 | | 3 |
| 68071-3682-6 | DIAZEPAM | 6 in 1 BOTTLE | TABLET | 6 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3682 | DIAZEPAM TABLET [NUCARE PHARMACEUTICALS, INC.] | 3 | Current NDC, 2 package rows | 20241228_21785bb2-cc96-7973-e063-6294a90ab1b8.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 |
|---|
| 68071-3682-1 | 68071368201 | 10 TABLET in 1 BOTTLE (68071-3682-1) | 10 tablet | 2024-09-06 | No | No | Historical |
| 68071-3682-6 | 68071368206 | 6 TABLET in 1 BOTTLE (68071-3682-6) | 6 tablet | 2024-09-06 | No | No | Historical |