Diazepam
- Product NDC
- 46708-811
- 11-digit product format
- 467080811
- Labeler code
- 46708
- Product ID
- 46708-811_5d20d4f6-965c-49b5-b1d1-1a778d565bef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diazepam
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA218450
- Marketing category
- ANDA
- Marketing start
- 2024-04-25
- Substance
- DIAZEPAM
- Active strength
- 10 mg/2mL
- 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 | 10 mg/2mL |
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 |
|---|
| 46708-811-02 | Diazepam | 2 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 2 | | 1 |
| 46708-811-20 | Diazepam | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-811 | DIAZEPAM INJECTION, SOLUTION [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 2 package rows | 20240501_1632f040-3b2c-43da-a42f-f2baf5ec778a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-811-02 | 46708081102 | 2 mL in 1 SYRINGE, GLASS | 2 ml | | | | Historical |
| 46708-811-20 | 46708081120 | 10 SYRINGE, GLASS in 1 CARTON (46708-811-20) / 2 mL in 1 SYRINGE, GLASS (46708-811-02) | | 2024-04-25 | No | No | Current |