Midazolam
- Product NDC
- 42571-415
- 11-digit product format
- 425710415
- Labeler code
- 42571
- Product ID
- 42571-415_03a665f9-f328-83d4-e063-6294a90a756a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Midazolam
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Micro Labs Limited
- Application
- ANDA217504
- Marketing category
- ANDA
- Marketing start
- 2024-01-01
- Substance
- MIDAZOLAM HYDROCHLORIDE
- Active strength
- 5 mg/mL
- 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/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W7TTW573JJ |
| Rxcui | 1666798, 1666814, 1666823 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42571-415-54 | Midazolam | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 1 |
| 42571-415-72 | Midazolam | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 1 |
| 42571-415-75 | Midazolam | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | | 1 |
| 42571-415-91 | 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 |
|---|
| 42571-415 | MIDAZOLAM (MIDAZOLAM) INJECTION, SOLUTION [MICRO LABS LIMITED] | 1 | Current NDC, 4 package rows | 20240101_9221894f-d840-46f2-a11c-6b71358d3b5b.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 |
|---|
| 42571-415-54 | 42571041554 | 1 mL in 1 VIAL | 1 ml | | | | Historical |
| 42571-415-72 | 42571041572 | 10 VIAL in 1 CARTON (42571-415-72) / 1 mL in 1 VIAL (42571-415-54) | 10 vial | 2024-01-01 | No | No | Current |
| 42571-415-75 | 42571041575 | 2 mL in 1 VIAL | 2 ml | | | | Historical |
| 42571-415-91 | 42571041591 | 10 VIAL in 1 CARTON (42571-415-91) / 2 mL in 1 VIAL (42571-415-75) | 10 vial | 2024-01-01 | No | No | Current |