Ofloxacin
- Product NDC
- 70069-411
- 11-digit product format
- 700690411
- Labeler code
- 70069
- Product ID
- 70069-411_d83e31c5-0a6d-49d6-afd8-34d0c406a401
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ofloxacin
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA213597
- Marketing category
- ANDA
- Marketing start
- 2024-10-10
- 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 |
|---|
| 70069-411-01 | Ofloxacin | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 4 |
| 70069-411-01 | Ofloxacin | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-411 | OFLOXACIN SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC] | 4 | Current NDC, 2 package rows | 20241015_4b2b893d-c19b-4c4a-85de-ff901325080b.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 |
|---|
| 70069-411-01 | 70069041101 | 1 BOTTLE in 1 CARTON (70069-411-01) / 5 mL in 1 BOTTLE | 1 bottle | 2024-10-10 | No | No | Current |