Midazolam In Sodium Chloride
- Product NDC
- 68083-619
- 11-digit product format
- 680830619
- Labeler code
- 68083
- Product ID
- 68083-619_fda891ec-dee1-4978-a550-8c10c1cf3d8c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Midazolam In Sodium Chloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA218993
- Marketing category
- ANDA
- Marketing start
- 2024-08-12
- 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 |
|---|
| 68083-619-10 | Midazolam In Sodium Chloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 5 |
| 68083-619-10 | Midazolam In Sodium Chloride | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-619 | MIDAZOLAM IN SODIUM CHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 5 | Current NDC, 2 package rows | 20240817_9ba78a7c-5b05-42a3-89cd-ca51ad9b2e6d.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 |
|---|
| 68083-619-10 | 68083061910 | 10 POUCH in 1 CARTON (68083-619-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG | 10 pouch | 2024-08-12 | No | No | Current |