Midazolam in Sodium Chloride
- Product NDC
- 0143-9379
- 11-digit product format
- 001439379
- Labeler code
- 0143
- Product ID
- 0143-9379_a6be32fe-dc3d-4ce0-b780-8ba6b4261acc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Midazolam in Sodium Chloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA216159
- Marketing category
- ANDA
- Marketing start
- 2023-05-19
- Substance
- MIDAZOLAM HYDROCHLORIDE
- Active strength
- 1 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 in Sodium Chloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MIDAZOLAM HYDROCHLORIDE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W7TTW573JJ |
| Rxcui | 2541170, 2541171 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-9379-01 | Midazolam in Sodium Chloride | 50 mL in 1 BAG | INJECTION | 50 | | 2 |
| 0143-9379-01 | Midazolam in Sodium Chloride | 1 in 1 POUCH | INJECTION | 1 | | 2 |
| 0143-9379-10 | Midazolam in Sodium Chloride | 10 in 1 CARTON | INJECTION | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9379 | MIDAZOLAM IN SODIUM CHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 2 | Current NDC, 3 package rows | 20230519_4155a60a-b023-4f4a-acae-7bb8fe9dc0c1.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 |
|---|
| 0143-9379-01 | 00143937901 | 50 mL in 1 BAG | 50 ml | | | | Historical |
| 0143-9379-10 | 00143937910 | 10 POUCH in 1 CARTON (0143-9379-10) / 1 BAG in 1 POUCH (0143-9379-01) / 50 mL in 1 BAG | 10 pouch | 2023-05-19 | No | No | Current |