Diazepam
- Product NDC
- 53002-3340
- 11-digit product format
- 530023340
- Labeler code
- 53002
- Product ID
- 53002-3340_f6381509-38b0-46e5-a0cc-24556bf705b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diazepam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA071321
- Marketing category
- ANDA
- Marketing start
- 1986-12-10
- Marketing end
- 0000-00-00
- Substance
- DIAZEPAM
- Active strength
- 5 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC],Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-3340-1 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-c739-f424-e053-dadaa90a57ce | Diazepam Tablets, USP, CIV Rx only |
| 53002-3340-2 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-c739-f424-e053-dadaa90a57ce | Diazepam Tablets, USP, CIV Rx only |
| 53002-3340-3 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-c739-f424-e053-dadaa90a57ce | Diazepam Tablets, USP, CIV Rx only |
| 53002-3340-1 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-c739-f424-e053-dadaa90a57ce | Diazepam Tablets, USP, CIV Rx only |
| 53002-3340-2 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-c739-f424-e053-dadaa90a57ce | Diazepam Tablets, USP, CIV Rx only |
| 53002-3340-3 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-c739-f424-e053-dadaa90a57ce | Diazepam Tablets, USP, CIV Rx only |
| 53002-3340-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-c739-f424-e053-dadaa90a57ce | Diazepam Tablets, USP, CIV Rx only |
| 53002-3340-2 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-c739-f424-e053-dadaa90a57ce | Diazepam Tablets, USP, CIV Rx only |
| 53002-3340-3 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-c739-f424-e053-dadaa90a57ce | Diazepam Tablets, USP, CIV Rx only |
| 53002-3340-1 | 2020-02-19 | C162847 | 48780-1 | 9d75b9d0-c739-f424-e053-dadaa90a57ce | Diazepam Tablets, USP, CIV Rx only |
| 53002-3340-2 | 2020-02-19 | C162847 | 48780-1 | 9d75b9d0-c739-f424-e053-dadaa90a57ce | Diazepam Tablets, USP, CIV Rx only |
| 53002-3340-3 | 2020-02-19 | C162847 | 48780-1 | 9d75b9d0-c739-f424-e053-dadaa90a57ce | Diazepam Tablets, USP, CIV Rx only |
| 53002-3340-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c739-f424-e053-dadaa90a57ce | Diazepam Tablets, USP, CIV Rx only |
| 53002-3340-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c739-f424-e053-dadaa90a57ce | Diazepam Tablets, USP, CIV Rx only |
| 53002-3340-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c739-f424-e053-dadaa90a57ce | Diazepam Tablets, USP, CIV Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-3340-1 | Diazepam | 10 in 1 BOTTLE | TABLET | 10 | | 7 |
| 53002-3340-2 | Diazepam | 20 in 1 BOTTLE | TABLET | 20 | | 7 |
| 53002-3340-3 | Diazepam | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-3340 | DIAZEPAM TABLET [RPK PHARMACEUTICALS, INC.] | 7 | Legacy NDC, 3 package rows | 20230609_7582f82f-67b8-4176-9f8c-369a0d0c993b.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 |
|---|
| 53002-3340-1 | 53002334001 | 10 TABLET in 1 BOTTLE (53002-3340-1) | 10 tablet | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-3340-2 | 53002334002 | 20 TABLET in 1 BOTTLE (53002-3340-2) | 20 tablet | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-3340-3 | 53002334003 | 30 TABLET in 1 BOTTLE (53002-3340-3) | 30 tablet | 2017-10-01 | 0000-00-00 | No | No | Current |