ofloxacin
- Product NDC
- 76420-749
- 11-digit product format
- 764200749
- Labeler code
- 76420
- Product ID
- 76420-749_1aaaf971-7d69-9422-e063-6394a90a2a69
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ofloxacin otic
- Dosage form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA216130
- Marketing category
- ANDA
- Marketing start
- 2022-07-15
- Substance
- OFLOXACIN
- Active strength
- 3 mg/mL
- Pharmacologic classes
- Quinolone Antimicrobial [EPC], Quinolones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| A4P49JAZ9H | OFLOXACIN | 82419-36-1 | OFLOXACIN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-749-10 | 76420074910 | 10 mL in 1 BOTTLE, DROPPER (76420-749-10) | 10 ml | 2024-06-12 | No | No | Historical |