GATIFLOXACIN
- Product NDC
- 69315-331
- 11-digit product format
- 693150331
- Labeler code
- 69315
- Product ID
- 69315-331_14b4bf1f-07ed-4578-96ac-47fc9c7c058b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GATIFLOXACIN
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Leading Pharma, LLC
- Application
- ANDA213542
- Marketing category
- ANDA
- Marketing start
- 2025-10-06
- Substance
- GATIFLOXACIN ANHYDROUS
- Active strength
- 5 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
- GATIFLOXACIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GATIFLOXACIN ANHYDROUS | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 81485Y3A9A |
| Rxcui | 992395 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69315-331-02 | GATIFLOXACIN | 2.5 mL in 1 BOTTLE | SOLUTION | 2.5 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69315-331-02 | 69315033102 | 2.5 mL in 1 BOTTLE (69315-331-02) | 2.5 ml | 2025-10-06 | No | No | Historical |