Diazepam
- Product NDC
- 69339-137
- 11-digit product format
- 693390137
- Labeler code
- 69339
- Product ID
- 69339-137_2a224626-a982-4a57-9ff6-8b4f69e0c4c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DIAZEPAM
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Natco Pharma USA LLC
- Application
- ANDA211998
- Marketing category
- ANDA
- Marketing start
- 2020-07-01
- 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 |
|---|
| 69339-137-01 | Diazepam | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 7 |
| 69339-137-05 | Diazepam | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 7 |
| 69339-137-91 | Diazepam | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 2 |
| 69339-137-95 | Diazepam | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69339-137 | DIAZEPAM INJECTION, SOLUTION [NATCO PHARMA USA LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241225_19d0e3e5-f081-4574-9f0a-e7e97a88c7a9.zip |
| 69339-137 | DIAZEPAM INJECTION, SOLUTION [NATCO PHARMA USA LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20230902_5993cd06-7ce2-4c7c-9364-f7f66aafc718.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 |
|---|
| 69339-137-01 | 69339013701 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | | | | | Historical |
| 69339-137-05 | 69339013705 | 5 VIAL, MULTI-DOSE in 1 CARTON (69339-137-05) / 10 mL in 1 VIAL, MULTI-DOSE (69339-137-01) | | 2020-07-01 | 0000-00-00 | No | No | Current |
| 69339-137-10 | 69339013710 | 10 VIAL, MULTI-DOSE in 1 CARTON (69339-137-10) > 10 mL in 1 VIAL, MULTI-DOSE (69339-137-01) | | 2020-07-01 | 0000-00-00 | No | No | Current |
| 69339-137-91 | 69339013791 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | | | | | Historical |
| 69339-137-95 | 69339013795 | 5 VIAL, MULTI-DOSE in 1 CARTON (69339-137-95) > 10 mL in 1 VIAL, MULTI-DOSE (69339-137-91) | | 2022-10-20 | 0000-00-00 | No | No | Current |