MIDAZOLAM
- Product NDC
- 52584-589
- 11-digit product format
- 525840589
- Labeler code
- 52584
- Product ID
- 52584-589_e3d72207-3f8a-41b7-8a76-17032a967e70
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- midazolam hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- General Injectables & Vaccines, Inc.
- Application
- ANDA090850
- Marketing category
- ANDA
- Marketing start
- 2018-12-24
- Marketing end
- 2023-05-31
- Substance
- MIDAZOLAM HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Benzodiazepine [EPC],Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52584-589-22 | 52584058922 | 1 VIAL, MULTI-DOSE in 1 BAG (52584-589-22) > 10 mL in 1 VIAL, MULTI-DOSE | 2018-12-24 | 2023-05-31 | No | No | Current |