Ofloxacin Otic
- Product NDC
- 68071-1630
- 11-digit product format
- 680711630
- Labeler code
- 68071
- Product ID
- 68071-1630_2a2f62dc-8ba6-7ca9-e063-6294a90aca76
- 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 |
|---|
| 68071-1630-3 | Ofloxacin Otic | 10 mL in 1 BOTTLE | SOLUTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-1630 | OFLOXACIN OTIC (OFLOXACIN) SOLUTION [NUCARE PHARMACEUTICALS,INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20241228_76f461da-0e15-aa6d-e053-2a91aa0a9808.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 |
|---|
| 68071-1630-3 | 68071163003 | 10 mL in 1 BOTTLE (68071-1630-3) | 10 ml | 2018-09-28 | 0000-00-00 | No | No | Current |