Diazepam Intensol
- Product NDC
- 0054-3185
- 11-digit product format
- 000543185
- Labeler code
- 0054
- Product ID
- 0054-3185_ab533d6f-4e34-4675-9da6-b93484134aca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diazepam Intensol
- Dosage form
- SOLUTION, CONCENTRATE
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA071415
- Marketing category
- ANDA
- Marketing start
- 1987-04-03
- Substance
- DIAZEPAM
- Active strength
- 5 mg/mL
- 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 Intensol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIAZEPAM | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q3JTX2Q7TU |
| Rxcui | 309844 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-3185-44 | Diazepam Intensol | 1 in 1 CARTON | SOLUTION, CONCENTRATE | 1 | | 13 |
| 0054-3185-44 | Diazepam Intensol | 30 mL in 1 BOTTLE | SOLUTION, CONCENTRATE | 30 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-3185 | DIAZEPAM INTENSOL SOLUTION, CONCENTRATE [HIKMA PHARMACEUTICALS USA INC.] | 13 | Current NDC, Legacy NDC, 2 package rows | 20241212_1aaf9375-ae3d-4fed-9cd1-24102e00be1a.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 |
|---|
| 0054-3185-44 | 00054318544 | 1 BOTTLE in 1 CARTON (0054-3185-44) / 30 mL in 1 BOTTLE | 1 bottle | 1987-04-03 | 0000-00-00 | No | No | Current |