Diazepam
- Product NDC
- 68475-802
- 11-digit product format
- 684750802
- Labeler code
- 68475
- Product ID
- 68475-802_a3cf4952-5564-4a2b-81f3-148d441c30ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diazepam
- Dosage form
- GEL
- Route
- RECTAL
- Labeler
- Navinta LLC
- Application
- ANDA217468
- Marketing category
- ANDA
- Marketing start
- 2026-02-06
- Substance
- DIAZEPAM
- Active strength
- 2.5 mg/.5mL
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diazepam
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIAZEPAM | 2.5 mg/.5mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68475-802-02 | Diazepam | 0.5 mL in 1 SYRINGE, PLASTIC | GEL | 0.5 | | 2 |
| 68475-802-02 | Diazepam | 2 in 1 PACKAGE | GEL | 2 | | 2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68475-802-02 | 68475080202 | 2 SYRINGE, PLASTIC in 1 PACKAGE (68475-802-02) / .5 mL in 1 SYRINGE, PLASTIC | 2026-02-06 | No | No | Current |