Diazepam
- Product NDC
- 21695-889
- 11-digit product format
- 216950889
- Labeler code
- 21695
- Product ID
- 21695-889_d1b5762f-307c-4c99-977d-d91d7dd22141
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diazepam
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Rebel Distributors Corp
- Application
- ANDA071583
- Marketing category
- ANDA
- Marketing start
- 1987-10-13
- Marketing end
- 0000-00-00
- Substance
- DIAZEPAM
- Active strength
- 5 mg/mL
- 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 |
|---|---|---|---|---|---|
| 21695-889-10 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4a3d-48b1-e053-8cdaa90a720a | DIAZEPAM Injection, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-889-10 | Diazepam | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 5 | 1 | |
| 21695-889-10 | Diazepam | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-889-10 | ML - Milliliter | 21695-889 | 8e8bdf59-afa1-453e-b6da-040cd7f21843 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Diazepam | ACTIVE INGREDIENT | Q3JTX2Q7TU | DIAZEPAM INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| Diazepam | ACTIVE MOIETY | Q3JTX2Q7TU | DIAZEPAM INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| Alcohol | INACTIVE INGREDIENT | 3K9958V90M | DIAZEPAM INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| Benzyl Alcohol | INACTIVE INGREDIENT | LKG8494WBH | DIAZEPAM INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | DIAZEPAM INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | DIAZEPAM INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309845 | diazePAM 5 MG/ML Injectable Solution | PSN | d1b5762f-307c-4c99-977d-d91d7dd22141 | 1 |
| 309845 | diazepam 5 MG/ML Injectable Solution | SCD | d1b5762f-307c-4c99-977d-d91d7dd22141 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 21695-889-10 | 21695088910 | 5 mL in 1 VIAL, MULTI-DOSE | 5 ml | Historical |