Diazepam
- Product NDC
- 0641-6244
- 11-digit product format
- 006416244
- Labeler code
- 0641
- Product ID
- 0641-6244_273ae796-6561-4aaf-a38b-ea61be408347
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diazepam
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA070313
- Marketing category
- ANDA
- Marketing start
- 2021-05-18
- 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 | 2120550 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0641-6244-10 | Diazepam | 10 in 1 CARTON | INJECTION | 10 | | 5 |
| 0641-6244-10 | Diazepam | 2 mL in 1 SYRINGE | INJECTION | 2 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0641-6244 | DIAZEPAM INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240410_2719720b-4918-4f08-b1de-b267f404505f.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 |
|---|
| 0641-6244-10 | 00641624410 | 10 SYRINGE in 1 CARTON (0641-6244-10) / 2 mL in 1 SYRINGE | 10 syringe | 2021-05-18 | 0000-00-00 | No | No | Current |