Midazolam
- Product NDC
- 70069-817
- 11-digit product format
- 700690817
- Labeler code
- 70069
- Product ID
- 70069-817_0bbe4e90-4c26-cbbb-e063-6294a90aad1b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- midazolam hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- SOMERSET THERAPEUTICS, LLC
- Application
- ANDA090315
- Marketing category
- ANDA
- Marketing start
- 2023-12-05
- Substance
- MIDAZOLAM HYDROCHLORIDE
- Active strength
- 5 mg/5mL
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Midazolam
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MIDAZOLAM HYDROCHLORIDE | 5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W7TTW573JJ |
| Rxcui | 1666798, 1666800 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70069-817-10 | Midazolam | 5 mL in 1 VIAL | INJECTION, SOLUTION | 5 | | 1 |
| 70069-817-10 | Midazolam | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-817 | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC] | 1 | Current NDC, 2 package rows | 20231205_74666098-1ca8-4c06-8fc4-5de870b1b514.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70069-817-10 | 70069081710 | 10 VIAL in 1 CARTON (70069-817-10) / 5 mL in 1 VIAL | 10 vial | 2023-12-05 | No | No | Current |