ofloxacin
- Product NDC
- 68071-3604
- 11-digit product format
- 680713604
- Labeler code
- 68071
- Product ID
- 68071-3604_1e91730c-0a19-c6d7-e063-6394a90a8395
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ofloxacin otic
- Dosage form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA216130
- Marketing category
- ANDA
- Marketing start
- 2023-12-01
- 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 |
|---|
| 68071-3604-3 | 68071360403 | 10 mL in 1 BOTTLE, DROPPER (68071-3604-3) | 10 ml | 2024-07-31 | No | No | Historical |