Ofloxacin
- Product NDC
- 65145-143
- 11-digit product format
- 651450143
- Labeler code
- 65145
- Product ID
- 65145-143_47f838f6-cc86-41f5-924a-f6f5c4ddc43e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ofloxacin Otic
- Dosage form
- SOLUTION/ DROPS
- Route
- AURICULAR (OTIC)
- Labeler
- Caplin Steriles Limited
- Application
- ANDA217903
- Marketing category
- ANDA
- Marketing start
- 2024-12-16
- 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 |
|---|
| 65145-143-01 | Ofloxacin | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 3 |
| 65145-143-01 | Ofloxacin | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65145-143 | OFLOXACIN (OFLOXACIN OTIC) SOLUTION/ DROPS OFLOXACIN (OFLOXACIN OTIC SOLUTION) SOLUTION/ DROPS [CAPLIN STERILES LIMITED] | 3 | Current NDC, 2 package rows | 20241218_2bb61a24-87a6-4e74-a319-fc5e7c483bbb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 65145-143-01 | 65145014301 | 1 BOTTLE, DROPPER in 1 CARTON (65145-143-01) / 5 mL in 1 BOTTLE, DROPPER | 2024-12-16 | No | No | Historical |