Midazolam
- Product NDC
- 82449-203
- 11-digit product format
- 824490203
- Labeler code
- 82449
- Product ID
- 82449-203_0c63b5cb-696a-9c6c-e063-6394a90a8fd9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- midazolam hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Steriscience Specialties Private Limited
- Application
- ANDA090315
- Marketing category
- ANDA
- Marketing start
- 2023-07-31
- 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
- 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, 1666800, 1666814, 1666823 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82449-203-02 | Midazolam | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 3 |
| 82449-203-02 | Midazolam | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82449-203 | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [STERISCIENCE SPECIALTIES PRIVATE LIMITED] | 3 | Current NDC, 2 package rows | 20231214_793416e3-25c6-4637-a025-b6c1465665c7.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 |
|---|
| 82449-203-02 | 82449020302 | 10 VIAL in 1 CARTON (82449-203-02) / 2 mL in 1 VIAL | 10 vial | 2023-07-31 | No | No | Historical |