Diazepam
- Product NDC
- 50436-3592
- 11-digit product format
- 504363592
- Labeler code
- 50436
- Product ID
- 50436-3592_a8b57ca8-723d-4637-b004-08802486356b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diazepam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unit Dose Services
- 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
- 2020-12-31
- 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 |
|---|---|---|---|---|---|
| 50436-3592-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1889-a910-e053-dadaa90a0b85 | Diazepam Tablets USP CIV Rx only |
| 50436-3592-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1889-a910-e053-dadaa90a0b85 | Diazepam Tablets USP CIV Rx only |
| 50436-3592-4 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1889-a910-e053-dadaa90a0b85 | Diazepam Tablets USP CIV Rx only |
| 50436-3592-5 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1889-a910-e053-dadaa90a0b85 | Diazepam Tablets USP CIV Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-3592-1 | Diazepam | 60 in 1 BOTTLE | TABLET | 60 | 12 | |
| 50436-3592-2 | Diazepam | 30 in 1 BOTTLE | TABLET | 30 | 12 | |
| 50436-3592-4 | Diazepam | 2 in 1 BOTTLE | TABLET | 2 | 12 | |
| 50436-3592-5 | Diazepam | 6 in 1 BOTTLE | TABLET | 6 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-3592-1 | EA - Each | 50436-3592 | 2fefdbcf-a99c-4541-9171-ffa498b8ea95 | 1 | 2012-07-24 |
| 50436-3592-2 | EA - Each | 50436-3592 | a8b45139-9c9b-492b-bf18-0c12310bd671 | 1 | 2012-07-24 |
| 50436-3592-4 | EA - Each | 50436-3592 | 82684ee0-dcb4-4923-8e82-2a10c3818dfa | 1 | 2014-12-01 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| DIAZEPAM | ACTIVE INGREDIENT | Q3JTX2Q7TU | DIAZEPAM TABLET [UNIT DOSE SERVICES] | 4 | |
| DIAZEPAM | ACTIVE MOIETY | Q3JTX2Q7TU | DIAZEPAM TABLET [UNIT DOSE SERVICES] | 4 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | DIAZEPAM TABLET [UNIT DOSE SERVICES] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DIAZEPAM TABLET [UNIT DOSE SERVICES] | 4 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | DIAZEPAM TABLET [UNIT DOSE SERVICES] | 4 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | DIAZEPAM TABLET [UNIT DOSE SERVICES] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DIAZEPAM TABLET [UNIT DOSE SERVICES] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DIAZEPAM TABLET [UNIT DOSE SERVICES] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | DIAZEPAM TABLET [UNIT DOSE SERVICES] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DIAZEPAM TABLET [UNIT DOSE SERVICES] | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-3592 | DIAZEPAM TABLET [UNIT DOSE SERVICES] | 12 | Legacy NDC, 4 package rows | 20171003_484acfc4-6f1a-4abe-9eaa-b1b8ea7f90e6.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197591 | diazePAM 5 MG Oral Tablet | PSN | 484acfc4-6f1a-4abe-9eaa-b1b8ea7f90e6 | 12 |
| 197591 | diazepam 5 MG Oral Tablet | SCD | 484acfc4-6f1a-4abe-9eaa-b1b8ea7f90e6 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-3592-1 | 50436359201 | 60 in 1 BOTTLE | Historical |
| 50436-3592-2 | 50436359202 | 30 in 1 BOTTLE | Historical |
| 50436-3592-4 | 50436359204 | 2 in 1 BOTTLE | Historical |
| 50436-3592-5 | 50436359205 | 6 in 1 BOTTLE | Historical |