Diazepam
- Product NDC
- 0641-6243
- 11-digit product format
- 006416243
- Labeler code
- 0641
- Product ID
- 0641-6243_19d85848-918f-4abb-b835-ff0679457d8a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diazepam
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA070311
- Marketing category
- ANDA
- Marketing start
- 1985-12-16
- 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
- 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 | 309845 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0641-6243-10 | Diazepam | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION | 10 | | 4 |
| 0641-6243-10 | Diazepam | 10 in 1 CARTON | INJECTION | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0641-6243 | DIAZEPAM INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 4 | Current NDC, 2 package rows | 20241121_f466f8a3-f31c-44f4-b0e8-444464f20f66.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0641-6243-10 | 00641624310 | 10 VIAL, MULTI-DOSE in 1 CARTON (0641-6243-10) / 10 mL in 1 VIAL, MULTI-DOSE | 1985-12-16 | No | No | Current |