Ofloxacin
- Product NDC
- 68071-3566
- 11-digit product format
- 680713566
- Labeler code
- 68071
- Product ID
- 68071-3566_102c825b-af5d-42e7-e063-6394a90a81a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ofloxacin
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- NuCare Pharmceuticals,Inc.
- Application
- ANDA076513
- Marketing category
- ANDA
- Marketing start
- 2019-03-01
- 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 |
|---|
| 68071-3566-1 | Ofloxacin | 10 mL in 1 BOTTLE, DROPPER | SOLUTION | 10 | | 1 |
| 68071-3566-1 | Ofloxacin | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3566 | OFLOXACIN SOLUTION [NUCARE PHARMCEUTICALS,INC.] | 1 | Current NDC, 2 package rows | 20240131_102c825b-af5c-42e7-e063-6394a90a81a1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3566-1 | 68071356601 | 1 BOTTLE, DROPPER in 1 CARTON (68071-3566-1) / 10 mL in 1 BOTTLE, DROPPER | 2024-01-30 | No | No | Current |