Diazepam
- Product NDC
- 70710-2078
- 11-digit product format
- 707102078
- Labeler code
- 70710
- Product ID
- 70710-2078_ef34ecf3-de17-4493-82ef-857565ac4340
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diazepam
- Dosage form
- GEL
- Route
- RECTAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA217468
- Marketing category
- ANDA
- Marketing start
- 2025-12-15
- Substance
- DIAZEPAM
- Active strength
- 2.5 mg/.5mL
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diazepam
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIAZEPAM | 2.5 mg/.5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | Q3JTX2Q7TU |
| Rxcui | 801957, 801961, 801966 |
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 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 2c487d7e-cbfc-4699-9c83-5c1c7521cde9 | Product name | 1 | 20200610 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 02ac201d-7ee6-00c9-f963-81bb5a506b68 | Product name | 3 | 20160816 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70710-2078-2 | Diazepam | 2 in 1 PACKAGE | GEL | 2 | 2 | |
| 70710-2078-2 | Diazepam | 0.5 mL in 1 SYRINGE, PLASTIC | GEL | 0.5 | 2 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 801961 | diazePAM 10 MG in 2 ML Rectal Gel | PSN | 652714c7-25c4-4d05-979d-8eee3b6f2f4d | 2 |
| 801957 | diazePAM 2.5 MG in 0.5 ML Rectal Gel | PSN | 652714c7-25c4-4d05-979d-8eee3b6f2f4d | 2 |
| 801966 | diazePAM 20 MG in 4 ML Rectal Gel | PSN | 652714c7-25c4-4d05-979d-8eee3b6f2f4d | 2 |
| 801957 | 0.5 ML diazepam 5 MG/ML Rectal Gel | SCD | 652714c7-25c4-4d05-979d-8eee3b6f2f4d | 2 |
| 801961 | 2 ML diazepam 5 MG/ML Rectal Gel | SCD | 652714c7-25c4-4d05-979d-8eee3b6f2f4d | 2 |
| 801966 | 4 ML diazepam 5 MG/ML Rectal Gel | SCD | 652714c7-25c4-4d05-979d-8eee3b6f2f4d | 2 |
| 801961 | diazepam 10 MG per 2 ML Rectal Gel | SY | 652714c7-25c4-4d05-979d-8eee3b6f2f4d | 2 |
| 801957 | diazepam 2.5 MG per 0.5 ML Rectal Gel | SY | 652714c7-25c4-4d05-979d-8eee3b6f2f4d | 2 |
| 801966 | diazepam 20 mg per 4 ML Rectal Gel | SY | 652714c7-25c4-4d05-979d-8eee3b6f2f4d | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 70710-2078-2 | 70710207802 | 2 SYRINGE, PLASTIC in 1 PACKAGE (70710-2078-2) / .5 mL in 1 SYRINGE, PLASTIC | 2025-12-15 | No | No | Current |