Ofloxacin
- Product NDC
- 68788-4086
- 11-digit product format
- 687884086
- Labeler code
- 68788
- Product ID
- 68788-4086_5f4213e4-de32-4c03-8800-e254b98538ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ofloxacin
- Dosage form
- SOLUTION/ DROPS
- Route
- AURICULAR (OTIC)
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA216328
- Marketing category
- ANDA
- Marketing start
- 2026-03-17
- Substance
- OFLOXACIN
- Active strength
- 3 mg/mL
- Pharmacologic classes
- Quinolone Antimicrobial [EPC], Quinolones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ofloxacin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OFLOXACIN | 3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A4P49JAZ9H |
| Rxcui | 242446 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-4086-1 | Ofloxacin | 10 mL in 1 BOTTLE | SOLUTION/ DROPS | 10 | | 1 |
| 68788-4086-1 | Ofloxacin | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-4086-1 | 68788408601 | 1 BOTTLE in 1 CARTON (68788-4086-1) / 10 mL in 1 BOTTLE | 1 bottle | 2026-03-17 | No | No | Historical |