Midazolam
- Product NDC
- 0641-6190
- 11-digit product format
- 006416190
- Labeler code
- 0641
- Product ID
- 0641-6190_9ed8a0bb-bfd0-4f63-aa40-9813dd4a8f4e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Midazolam
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA075243
- Marketing category
- ANDA
- Marketing start
- 2000-06-20
- 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, 1666798 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0641-6190-01 | Midazolam | 10 mL in 1 VIAL | INJECTION | 10 | | 8 |
| 0641-6190-10 | Midazolam | 10 in 1 CARTON | INJECTION | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0641-6190 | MIDAZOLAM INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20241219_f8bb3427-c887-47b6-8042-8a21dc161c79.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 |
|---|
| 0641-6190-01 | 00641619001 | 10 mL in 1 VIAL | 10 ml | | | | | Historical |
| 0641-6190-10 | 00641619010 | 10 VIAL in 1 CARTON (0641-6190-10) / 10 mL in 1 VIAL (0641-6190-01) | 10 vial | 2000-06-20 | 0000-00-00 | No | No | Current |