ofloxacin
- Product NDC
- 68788-8449
- 11-digit product format
- 687888449
- Labeler code
- 68788
- Product ID
- 68788-8449_58078c0a-8299-42fb-9e63-5d479a021aad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ofloxacin
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA215886
- Marketing category
- ANDA
- Marketing start
- 2023-05-25
- 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 |
|---|
| 68788-8449-5 | ofloxacin | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 3 |
| 68788-8449-5 | 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 |
|---|
| 68788-8449 | OFLOXACIN SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS INC.] | 2 | Current NDC, 2 package rows | 20240726_306ed758-3c43-4f42-bd44-562ec65891dc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8449-5 | 68788844905 | 1 BOTTLE, DROPPER in 1 CARTON (68788-8449-5) / 5 mL in 1 BOTTLE, DROPPER | 2023-05-25 | No | No | Historical |