Midazolam Hydrochloride
- Product NDC
- 68083-108
- 11-digit product format
- 680830108
- Labeler code
- 68083
- Product ID
- 68083-108_3b7a93cb-a43a-46d0-ad52-6fba91da232d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Midazolam Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA090850
- Marketing category
- ANDA
- Marketing start
- 2012-06-01
- 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 Hydrochloride
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-108-01 | Midazolam Hydrochloride | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 5 | | 13 |
| 68083-108-01 | Midazolam Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 13 |
| 68083-108-02 | Midazolam Hydrochloride | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 13 |
| 68083-108-02 | Midazolam Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-108 | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 13 | Current NDC, Legacy NDC, 4 package rows | 20231017_81b2f48d-a05c-4301-8fee-761af220d44f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68083-108-01 | 68083010801 | 10 VIAL, MULTI-DOSE in 1 CARTON (68083-108-01) / 5 mL in 1 VIAL, MULTI-DOSE | 2012-06-01 | 0000-00-00 | No | No | Current |
| 68083-108-02 | 68083010802 | 10 VIAL, MULTI-DOSE in 1 CARTON (68083-108-02) / 10 mL in 1 VIAL, MULTI-DOSE | 2012-06-01 | 0000-00-00 | No | No | Current |