Ofloxacin
- Product NDC
- 68071-1607
- 11-digit product format
- 680711607
- Labeler code
- 68071
- Product ID
- 68071-1607_2a07b00e-964b-c66b-e063-6394a90a4822
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ofloxacin
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA076407
- Marketing category
- ANDA
- Marketing start
- 2008-07-01
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-1607-5 | Ofloxacin | 5 mL in 1 BOX | SOLUTION/ DROPS | 5 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-1607 | OFLOXACIN SOLUTION/ DROPS [NUCARE PHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20241226_51f3d155-36df-4c40-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-1607-5 | 68071160705 | 5 mL in 1 BOX (68071-1607-5) | 5 ml | 2017-06-14 | 0000-00-00 | No | No | Current |