Ofloxacin Otic
- Product NDC
- 68071-1588
- 11-digit product format
- 680711588
- Labeler code
- 68071
- Product ID
- 68071-1588_1d7a24e6-549c-9297-e063-6394a90a8372
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ofloxacin
- Dosage form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA076527
- Marketing category
- ANDA
- Marketing start
- 2004-05-14
- 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 Otic
- 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 | 242446 |
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 |
|---|
| 68071-1588-5 | Ofloxacin Otic | 5 mL in 1 BOTTLE | SOLUTION | 5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-1588 | OFLOXACIN OTIC (OFLOXACIN) SOLUTION [NUCARE PHARMACEUTICALS,INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240726_79ef87c3-1f09-1625-e053-2991aa0a84ae.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 |
|---|
| 68071-1588-5 | 68071158805 | 5 mL in 1 BOTTLE (68071-1588-5) | 5 ml | 2018-11-05 | 0000-00-00 | No | No | Current |