Diazepam
- Product NDC
- 68788-8462
- 11-digit product format
- 687888462
- Labeler code
- 68788
- Product ID
- 68788-8462_66b8a3e7-24fc-4d11-8855-b9ad94e677c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diazepam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA070325
- Marketing category
- ANDA
- Marketing start
- 2023-06-21
- Substance
- DIAZEPAM
- Active strength
- 10 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
- Diazepam
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIAZEPAM | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q3JTX2Q7TU |
| Rxcui | 197589 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8462-2 | Diazepam | 20 in 1 BOTTLE, PLASTIC | TABLET | 20 | | 4 |
| 68788-8462-3 | Diazepam | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8462 | DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS INC.] | 3 | Current NDC, 2 package rows | 20250316_6dcbb5e9-1e8f-4069-9244-adb46356714d.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 |
|---|
| 68788-8462-2 | 68788846202 | 20 TABLET in 1 BOTTLE, PLASTIC (68788-8462-2) | 20 tablet | 2023-06-21 | No | No | Historical |
| 68788-8462-3 | 68788846203 | 30 TABLET in 1 BOTTLE, PLASTIC (68788-8462-3) | 30 tablet | 2023-06-21 | No | No | Historical |