Diazepam
- Product NDC
- 0378-0345
- 11-digit product format
- 003780345
- Labeler code
- 0378
- Product ID
- 0378-0345_983a3fdc-04ca-4621-a57c-56ad36015d36
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diazepam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA070325
- Marketing category
- ANDA
- Marketing start
- 1985-09-04
- Substance
- DIAZEPAM
- Active strength
- 5 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 | 5 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 |
|---|
| 0378-0345-01 | Diazepam | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 15 |
| 0378-0345-05 | Diazepam | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 15 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-0345 | DIAZEPAM TABLET [MYLAN PHARMACEUTICALS INC.] | 14 | Current NDC, Legacy NDC, 2 package rows | 20240328_c397a9da-862f-4f3f-8109-7d21691de53a.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 |
|---|
| 0378-0345-01 | 00378034501 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0345-01) | 100 tablet | 1985-09-04 | 0000-00-00 | No | No | Current |
| 0378-0345-05 | 00378034505 | 500 TABLET in 1 BOTTLE, PLASTIC (0378-0345-05) | 500 tablet | 1985-09-04 | 0000-00-00 | No | No | Current |