Diazepam
- Product NDC
- 67296-0506
- 11-digit product format
- 672960506
- Labeler code
- 67296
- Product ID
- 67296-0506_0f905f40-eed8-47a7-bd55-0fdacc5fcc55
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diazepam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RedPharm Drug Inc.
- Application
- ANDA071135
- Marketing category
- ANDA
- Marketing start
- 2006-05-01
- Marketing end
- 0000-00-00
- Substance
- DIAZEPAM
- Active strength
- 5 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC],Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 69057c52-36b0-21c0-02d6-d697be15c03c | Product name | 4 | 20260305 |
| da74e203-d183-4c62-8511-c3ef56b5964e | Product name | 1 | 20250213 |
| 2792dd44-ff30-4712-8b05-1850c2b4d307 | Product name | 3 | 20250211 |
| 2fd3ebb9-86c1-64e3-e9b6-3c2ba01c6876 | Product name | 2 | 20250102 |
| 0f898f8b-23f1-b816-6bfe-c7f8aac7e42b | Product name | 2 | 20240529 |
| 2c487d7e-cbfc-4699-9c83-5c1c7521cde9 | Product name | 1 | 20200610 |
| 02ac201d-7ee6-00c9-f963-81bb5a506b68 | Product name | 3 | 20160816 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67296-0506-1 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d766-8e05-e053-dbdaa90a074a | Drug label sections C16H13ClN2O M.W. 284.74 Diazepam Tablets USP 2 mg, 5 mg and 10 mg, for oral administration, contain the following inactive ingredients: anhydrous lactose, magnesium stearate and microcrystalline cellulose. Diazepam Tablets USP 5 mg also contain D&C Yellow No. 10. Diazepam Tablets USP 10 mg also contain FD&C Blue No. 1. |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67296-0506-1 | Diazepam | 15 in 1 BOTTLE | TABLET | 15 | 3 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| diazepam | ACTIVE INGREDIENT | Q3JTX2Q7TU | DIAZEPAM TABLET [REDPHARM DRUG INC.] | 3 | |
| diazepam | ACTIVE MOIETY | Q3JTX2Q7TU | DIAZEPAM TABLET [REDPHARM DRUG INC.] | 3 | |
| anhydrous lactose | INACTIVE INGREDIENT | 3SY5LH9PMK | DIAZEPAM TABLET [REDPHARM DRUG INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DIAZEPAM TABLET [REDPHARM DRUG INC.] | 3 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | DIAZEPAM TABLET [REDPHARM DRUG INC.] | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67296-0506 | DIAZEPAM TABLET [REDPHARM DRUG INC.] | 3 | Legacy NDC, 1 package rows | 20101210_0fab9e5b-395c-4b32-bbad-3e23b4059d2b.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197591 | diazePAM 5 MG Oral Tablet | PSN | 0fab9e5b-395c-4b32-bbad-3e23b4059d2b | 3 |
| 197591 | diazepam 5 MG Oral Tablet | SCD | 0fab9e5b-395c-4b32-bbad-3e23b4059d2b | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 67296-0506-1 | 67296050601 | 15 in 1 BOTTLE | Historical |