Diazepam
- Product NDC
- 43386-281
- 11-digit product format
- 433860281
- Labeler code
- 43386
- Product ID
- 43386-281_91b10d2a-111a-4f2b-8b9a-d9c5d4a783f5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diazepam
- Dosage form
- GEL
- Route
- RECTAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA091076
- Marketing category
- ANDA
- Marketing start
- 2023-10-30
- Substance
- DIAZEPAM
- Active strength
- 20 mg/4g
- 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 | 20 mg/4g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q3JTX2Q7TU |
| Rxcui | 801961, 801966 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43386-281-01 | Diazepam | 2 in 1 PACKAGE | GEL | 2 | | 8 |
| 43386-281-02 | Diazepam | 1 in 1 CARTON | GEL | 1 | | 8 |
| 43386-281-03 | Diazepam | 4 g in 1 SYRINGE | GEL | 4 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-281 | DIAZEPAM GEL [LUPIN PHARMACEUTICALS,INC.] | 7 | Current NDC, 3 package rows | 20231216_d99b68aa-b3dc-49c8-8894-3da255cd26b0.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 |
|---|
| 43386-281-01 | 43386028101 | 2 in 1 PACKAGE | | | | | Historical |
| 43386-281-02 | 43386028102 | 1 PACKAGE in 1 CARTON (43386-281-02) / 2 SYRINGE in 1 PACKAGE (43386-281-01) / 4 g in 1 SYRINGE (43386-281-03) | 1 package | 2023-10-30 | Yes | No | Current |
| 43386-281-03 | 43386028103 | 4 g in 1 SYRINGE | 4 g | | | | Historical |