OFLOXACIN
- Product NDC
- 69315-320
- 11-digit product format
- 693150320
- Labeler code
- 69315
- Product ID
- 69315-320_88154ff7-fd59-4fd3-a82e-e55d3b6192bd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OFLOXACIN
- Dosage form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Labeler
- Leading Pharma, LLC
- Application
- ANDA217903
- Marketing category
- ANDA
- Marketing start
- 2024-03-01
- 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
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 |
|---|
| 69315-320-05 | OFLOXACIN | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | | 4 |
| 69315-320-10 | OFLOXACIN | 10 mL in 1 BOTTLE, DROPPER | SOLUTION | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69315-320 | OFLOXACIN SOLUTION [LEADING PHARMA, LLC] | 4 | Current NDC, 2 package rows | 20240410_e43bf505-1030-49cd-a144-19b997fb5575.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 |
|---|
| 69315-320-05 | 69315032005 | 5 mL in 1 BOTTLE, DROPPER (69315-320-05) | 5 ml | 2024-03-01 | No | No | Historical |
| 69315-320-10 | 69315032010 | 10 mL in 1 BOTTLE, DROPPER (69315-320-10) | 10 ml | 2024-03-01 | No | No | Historical |