Midazolam
- Product NDC
- 76045-001
- 11-digit product format
- 760450001
- Labeler code
- 76045
- Product ID
- 76045-001_ec9c9aee-b95f-4645-bf17-df7f1e3967d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Midazolam Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA203460
- Marketing category
- ANDA
- Marketing start
- 2014-10-03
- Substance
- MIDAZOLAM HYDROCHLORIDE
- Active strength
- 2 mg/2mL
- 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 | 2 mg/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W7TTW573JJ |
| Rxcui | 998211, 1551393, 1551395 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76045-001-00 | Midazolam | 1 in 1 BLISTER PACK | INJECTION, SOLUTION | 1 | | 16 |
| 76045-001-00 | Midazolam | 2 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 2 | | 16 |
| 76045-001-20 | Midazolam | 24 in 1 CARTON | INJECTION, SOLUTION | 24 | | 16 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76045-001 | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] | 16 | Current NDC, Legacy NDC, 3 package rows | 20240119_1cc9ba6e-fa1b-405e-9de8-720c567b2a73.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76045-001-00 | 76045000100 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 76045-001-20 | 76045000120 | 24 BLISTER PACK in 1 CARTON (76045-001-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-001-00) / 2 mL in 1 SYRINGE, GLASS | 24 blister pack | 2014-10-03 | 0000-00-00 | No | No | Current |