Ofloxacin
- Product NDC
- 65145-142
- 11-digit product format
- 651450142
- Labeler code
- 65145
- Product ID
- 65145-142_b7001e6b-0d32-4256-8352-058bc49b9782
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ofloxacin Ophthalmic Solution USP, 0.3%
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Caplin Steriles Limited
- Application
- ANDA217904
- Marketing category
- ANDA
- Marketing start
- 2025-02-05
- 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 |
|---|
| 65145-142-01 | Ofloxacin | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65145-142 | OFLOXACIN (OFLOXACIN OPHTHALMIC SOLUTION USP, 0.3%) SOLUTION/ DROPS [CAPLIN STERILES LIMITED] | 2 | Current NDC, 1 package rows | 20250207_53f7ec2e-5b4c-4f8c-b8ba-7f8844e0c01b.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 |
|---|
| 65145-142-01 | 65145014201 | 10 mL in 1 BOTTLE, DROPPER (65145-142-01) | 10 ml | 2025-02-05 | No | No | Current |