Midazolam
- Product NDC
- 0409-0001
- 11-digit product format
- 004090001
- Labeler code
- 0409
- Product ID
- 0409-0001_74093865-864a-49e8-99b9-c985fe72afb2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MIDAZOLAM HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA075857
- Marketing category
- ANDA
- Marketing start
- 2025-01-27
- Substance
- MIDAZOLAM HYDROCHLORIDE
- Active strength
- 1 mg/mL
- 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
- Midazolam
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MIDAZOLAM HYDROCHLORIDE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W7TTW573JJ |
| Rxcui | 1666798, 1666800, 1666814, 1666823 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0409-0001-01 | Midazolam | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 2 | | 34 |
| 0409-0001-25 | Midazolam | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 34 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MIDAZOLAM HYDROCHLORIDE | ACTIVE INGREDIENT | W7TTW573JJ | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| MIDAZOLAM | ACTIVE MOIETY | R60L0SM5BC | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 13 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-0001 | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 31 | Current NDC, 2 package rows | 20250129_1abda8b8-48a8-4995-af86-39220d1aa240.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 |
|---|
| 0409-0001-01 | 00409000101 | 2 mL in 1 VIAL, SINGLE-DOSE | 2 ml | | | | Historical |
| 0409-0001-25 | 00409000125 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0409-0001-25) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-0001-01) | | 2025-01-27 | No | No | Current |