Diazepam
- Product NDC
- 68071-4922
- 11-digit product format
- 680714922
- Labeler code
- 68071
- Product ID
- 68071-4922_1ae25c30-4082-3b15-e063-6394a90af42f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diazepam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA071321
- Marketing category
- ANDA
- Marketing start
- 1986-12-10
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-4922-1 | Diazepam | 10 in 1 BOTTLE | TABLET | 10 | | 5 |
| 68071-4922-4 | Diazepam | 8 in 1 BOTTLE | TABLET | 8 | | 5 |
| 68071-4922-6 | Diazepam | 6 in 1 BOTTLE | TABLET | 6 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4922 | DIAZEPAM TABLET [NUCARE PHARMACEUTICALS,INC.] | 5 | Current NDC, Legacy NDC, 3 package rows | 20240616_8b3cc5c9-91bd-7467-e053-2a95a90a44b8.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 |
|---|
| 68071-4922-1 | 68071492201 | 10 TABLET in 1 BOTTLE (68071-4922-1) | 10 tablet | 2019-06-13 | 0000-00-00 | No | No | Current |
| 68071-4922-4 | 68071492204 | 8 TABLET in 1 BOTTLE (68071-4922-4) | 8 tablet | 2019-06-13 | | No | No | Current |
| 68071-4922-6 | 68071492206 | 6 TABLET in 1 BOTTLE (68071-4922-6) | 6 tablet | 2019-06-13 | 0000-00-00 | No | No | Current |