Midazolam
- Product NDC
- 0404-9801
- 11-digit product format
- 004049801
- Labeler code
- 0404
- Product ID
- 0404-9801_425d6ca2-4545-4cf1-9c27-221d4f3e98c2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Midazolam
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA075243
- Marketing category
- ANDA
- Marketing start
- 2024-12-03
- 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 | 311702 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9801-10 | Midazolam | 10 mL in 1 VIAL | INJECTION | 10 | | 2 |
| 0404-9801-10 | Midazolam | 1 in 1 BAG | INJECTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9801 | MIDAZOLAM INJECTION [HENRY SCHEIN, INC.] | 1 | Current NDC, 2 package rows | 20241225_78e28b13-414e-4c34-a42c-caf1c3ba1f54.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 |
|---|
| 0404-9801-10 | 00404980110 | 1 VIAL in 1 BAG (0404-9801-10) / 10 mL in 1 VIAL | 1 vial | 2024-12-03 | No | No | Current |