Midazolam In Sodium Chloride
- Product NDC
- 65219-650
- 11-digit product format
- 652190650
- Labeler code
- 65219
- Product ID
- 65219-650_a43f63a4-8a7f-4a1b-b9a0-4198486cfef6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Midazolam In Sodium Chloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- FRESENIUS KABI USA, LLC
- Application
- ANDA218993
- Marketing category
- ANDA
- Marketing start
- 2025-01-15
- 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 |
|---|
| 65219-650-10 | Midazolam In Sodium Chloride | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 2 |
| 65219-650-10 | Midazolam In Sodium Chloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 2 |
| 65219-650-50 | Midazolam In Sodium Chloride | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 2 |
| 65219-650-50 | Midazolam In Sodium Chloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-650 | MIDAZOLAM IN SODIUM CHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | Current NDC, 4 package rows | 20250206_c8f51630-e776-4bc6-ba4d-b714e8c3b8f2.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 |
|---|
| 65219-650-10 | 65219065010 | 10 POUCH in 1 CARTON (65219-650-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG | 10 pouch | 2025-01-15 | No | No | Current |
| 65219-650-50 | 65219065050 | 10 POUCH in 1 CARTON (65219-650-50) / 1 BAG in 1 POUCH / 50 mL in 1 BAG | 10 pouch | 2025-01-15 | No | No | Current |