Midazolam Hydrochloride
- Product NDC
- 0404-9916
- 11-digit product format
- 004049916
- Labeler code
- 0404
- Product ID
- 0404-9916_cf4854ec-c2d6-486d-9712-ffe9dac99926
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Midazolam Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA075857
- Marketing category
- ANDA
- Marketing start
- 2022-01-17
- 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 Hydrochloride
- 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 | 1666814, 1666823 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9916-01 | Midazolam Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 6 |
| 0404-9916-01 | Midazolam Hydrochloride | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 6 |
| 0404-9916-02 | Midazolam Hydrochloride | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 6 |
| 0404-9916-02 | Midazolam Hydrochloride | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 2 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9916 | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HENRY SCHEIN, INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20250326_9e3bd5d3-36b3-471c-b8cc-ef48645700c2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0404-9916-01 | 00404991601 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9916-01) / 1 mL in 1 VIAL, SINGLE-DOSE | 2022-01-17 | 0000-00-00 | No | No | Current |
| 0404-9916-02 | 00404991602 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9916-02) / 2 mL in 1 VIAL, SINGLE-DOSE | 2022-01-17 | 0000-00-00 | No | No | Current |