Midazolam hydrochloride
- Product NDC
- 68083-106
- 11-digit product format
- 680830106
- Labeler code
- 68083
- Product ID
- 68083-106_7cdbef99-3a3a-4612-ab9f-eeb13fbd7066
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Midazolam hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA090696
- Marketing category
- ANDA
- Marketing start
- 2012-06-01
- 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 hydrochloride
- 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 | 1666798 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-106-01 | Midazolam hydrochloride | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 2 | | 12 |
| 68083-106-01 | Midazolam hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-106 | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 12 | Current NDC, Legacy NDC, 2 package rows | 20221117_23f4df96-1151-4815-8f01-4d79e5aa2145.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 |
|---|
| 68083-106-01 | 68083010601 | 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-106-01) / 2 mL in 1 VIAL, SINGLE-DOSE | 2012-06-01 | 0000-00-00 | No | No | Current |