ofloxacin
- Product NDC
- 70518-3984
- 11-digit product format
- 705183984
- Labeler code
- 70518
- Product ID
- 70518-3984_3f8f78f1-534a-08e7-e063-6294a90a6718
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ofloxacin otic
- Dosage form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA216130
- Marketing category
- ANDA
- Marketing start
- 2024-01-14
- 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 |
|---|
| 70518-3984-0 | ofloxacin | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3984 | OFLOXACIN (OFLOXACIN OTIC) SOLUTION [REMEDYREPACK INC.] | 1 | Current NDC, 1 package rows | 20240117_fe619d50-49bf-4fcc-9428-6108c45580eb.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 |
|---|
| 70518-3984-0 | 70518398400 | 5 mL in 1 BOTTLE, DROPPER (70518-3984-0) | 5 ml | 2024-01-14 | No | No | Historical |