Gatifloxacin Ophthalmic Solution 0.5%
- Product NDC
- 65145-207
- 11-digit product format
- 651450207
- Labeler code
- 65145
- Product ID
- 65145-207_2dc44fc5-b7fc-40ec-8e9b-d86fae1fc523
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gatifloxacin Ophthalmic Solution 0.5%
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Caplin Steriles Limited
- 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 Ophthalmic Solution 0.5%
- 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 |
|---|
| 65145-207-01 | Gatifloxacin Ophthalmic Solution 0.5% | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
| 65145-207-01 | Gatifloxacin Ophthalmic Solution 0.5% | 2.5 mL in 1 BOTTLE | SOLUTION | 2.5 | | 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 |
|---|
| 65145-207-01 | 65145020701 | 1 BOTTLE in 1 CARTON (65145-207-01) / 2.5 mL in 1 BOTTLE | 1 bottle | 2025-10-06 | No | No | Current |