OFLOXACIN
- Product NDC
- 69315-327
- 11-digit product format
- 693150327
- Labeler code
- 69315
- Product ID
- 69315-327_f468adb2-e4c3-4c2d-ba1d-af8e9319d035
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OFLOXACIN
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Leading Pharma, LLC
- Application
- ANDA217904
- Marketing category
- ANDA
- Marketing start
- 2024-07-15
- 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
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 | 312075 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69315-327-05 | OFLOXACIN | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | | 1 |
| 69315-327-10 | OFLOXACIN | 10 mL in 1 BOTTLE, DROPPER | SOLUTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69315-327 | OFLOXACIN SOLUTION [LEADING PHARMA, LLC] | 1 | Current NDC, 2 package rows | 20240715_7552729e-a41e-4eb1-8b37-b48a86112790.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 |
|---|
| 69315-327-05 | 69315032705 | 5 mL in 1 BOTTLE, DROPPER (69315-327-05) | 5 ml | 2024-07-15 | No | No | Historical |
| 69315-327-10 | 69315032710 | 10 mL in 1 BOTTLE, DROPPER (69315-327-10) | 10 ml | 2024-07-15 | No | No | Historical |