Diazepam
- Product NDC
- 62135-768
- 11-digit product format
- 621350768
- Labeler code
- 62135
- Product ID
- 62135-768_4517b811-0a91-89f5-e063-6294a90a9a30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diazepam Oral Solution (Concentrate)
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA204433
- Marketing category
- ANDA
- Marketing start
- 2014-04-14
- 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 | 309843, 309844 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-768-43 | Diazepam | 30 mL in 1 BOTTLE | SOLUTION | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-768 | DIAZEPAM (DIAZEPAM ORAL SOLUTION (CONCENTRATE)) SOLUTION DIAZEPAM (DIAZEPAM ORAL) SOLUTION [CHARTWELL RX, LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20241024_cdb839fb-27e5-4a11-aed6-da0a7ab6e996.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 |
|---|
| 62135-768-43 | 62135076843 | 30 mL in 1 BOTTLE (62135-768-43) | 30 ml | 2022-08-17 | 0000-00-00 | No | No | Current |