Ofloxacin
- Product NDC
- 68788-8761
- 11-digit product format
- 687888761
- Labeler code
- 68788
- Product ID
- 68788-8761_d359da57-ad0c-4b2d-87bf-70c596c7a371
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ofloxacin
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA076513
- Marketing category
- ANDA
- Marketing start
- 2024-11-11
- Substance
- OFLOXACIN
- Active strength
- 3 mg/mL
- Pharmacologic classes
- Quinolone Antimicrobial [EPC], Quinolones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ofloxacin
- Listing expiration
- 2027-12-31
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 |
|---|
| 68788-8761-5 | Ofloxacin | 1 in 1 CARTON | SOLUTION | 1 | | 2 |
| 68788-8761-5 | 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 |
|---|
| 68788-8761 | OFLOXACIN SOLUTION [PREFERRED PHARMACEUTICALS INC.] | 1 | Current NDC, 2 package rows | 20241113_f7916bb3-7593-45f8-b9de-98e0f2d57227.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8761-5 | 68788876105 | 1 BOTTLE, DROPPER in 1 CARTON (68788-8761-5) / 5 mL in 1 BOTTLE, DROPPER | 2024-11-11 | No | No | Historical |