Gentamicin
- Product NDC
- 52584-010
- 11-digit product format
- 525840010
- Labeler code
- 52584
- Product ID
- 52584-010_7bc0efa2-f433-4e0f-bbae-f9282456b746
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gentamicin Sulfate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- General Injectables & Vaccines, Inc
- Application
- ANDA062366
- Marketing category
- ANDA
- Marketing start
- 2010-09-01
- Marketing end
- 2023-02-28
- Substance
- GENTAMICIN SULFATE
- Active strength
- 40 mg/mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
- 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 |
|---|
| 52584-010-20 | 52584001020 | 1 VIAL, MULTI-DOSE in 1 BAG (52584-010-20) > 20 mL in 1 VIAL, MULTI-DOSE | 2010-09-01 | 0000-00-00 | No | No | Current |