Gatifloxacin
- Product NDC
- 0378-5431
- 11-digit product format
- 003785431
- Labeler code
- 0378
- Product ID
- 0378-5431_6e7c741c-1750-4d2a-ba6c-f710be10a53b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gatifloxacin
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA206446
- Marketing category
- ANDA
- Marketing start
- 2019-03-08
- Marketing end
- 0000-00-00
- Substance
- GATIFLOXACIN
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Quinolone Antimicrobial [EPC],Quinolones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-5431-35 | 00378543135 | 1 BOTTLE in 1 CARTON (0378-5431-35) > 2.5 mL in 1 BOTTLE | 1 bottle | 2019-03-08 | 0000-00-00 | No | No | Current |