Diazepam
- Product NDC
- 0054-3188
- 11-digit product format
- 000543188
- Labeler code
- 0054
- Product ID
- 0054-3188_d1ff8e50-faf9-4475-9fa0-314a620f8869
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diazepam
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA070928
- Marketing category
- ANDA
- Marketing start
- 1987-04-03
- Substance
- DIAZEPAM
- Active strength
- 5 mg/5mL
- 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/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q3JTX2Q7TU |
| Rxcui | 309843 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-3188-63 | Diazepam | 500 mL in 1 BOTTLE, PLASTIC | SOLUTION | 500 | | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-3188 | DIAZEPAM SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 8 | Current NDC, Legacy NDC, 1 package rows | 20241206_9e85abed-1a8b-4762-a31f-f2c7f196b8af.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 |
|---|
| 0054-3188-63 | 00054318863 | 500 mL in 1 BOTTLE, PLASTIC (0054-3188-63) | 500 ml | 1987-04-03 | 0000-00-00 | No | No | Current |