ofloxacin
- Product NDC
- 68788-8551
- 11-digit product format
- 687888551
- Labeler code
- 68788
- Product ID
- 68788-8551_2eccb4ad-20f4-4c07-a3e9-77c1f8bc77b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ofloxacin otic
- Dosage form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA216130
- Marketing category
- ANDA
- Marketing start
- 2023-11-15
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ofloxacin
- Listing expiration
- 2026-12-31
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 |
|---|
| 68788-8551-1 | ofloxacin | 10 mL in 1 BOTTLE, DROPPER | SOLUTION | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8551 | OFLOXACIN (OFLOXACIN OTIC) SOLUTION [PREFERRED PHARMACEUTICALS INC.] | 2 | Current NDC, 1 package rows | 20240726_adad0c8f-f591-4bac-a1bd-4e2a451f4f35.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8551-1 | 68788855101 | 10 mL in 1 BOTTLE, DROPPER (68788-8551-1) | 10 ml | 2023-11-15 | No | No | Historical |