ofloxacin otic

Generic: ofloxacin

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin otic
Generic Name ofloxacin
Labeler nucare pharmaceuticals,inc.
Dosage Form SOLUTION
Routes
AURICULAR (OTIC)
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-1630
Product ID 68071-1630_2a2f62dc-8ba6-7ca9-e063-6294a90aca76
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076527
Listing Expiration 2026-12-31
Marketing Start 2004-05-14

Pharmacologic Class

Established (EPC)
quinolone antimicrobial [epc]
Chemical Structure
quinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680711630
Hyphenated Format 68071-1630

Supplemental Identifiers

RxCUI
242446
UPC
0368071163032
UNII
A4P49JAZ9H
NUI
N0000175937 M0023650

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ofloxacin otic (source: ndc)
Generic Name ofloxacin (source: ndc)
Application Number ANDA076527 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 10 mL in 1 BOTTLE (68071-1630-3)
source: ndc

Packages (1)

68071-1630-3 10 mL in 1 BOTTLE (68071-1630-3)

Ingredients (1)

ofloxacin (3 mg/mL)

Linked Drug Pages (1)

Ofloxacin Otic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "2a2f62dc-8ba6-7ca9-e063-6294a90aca76", "openfda": {"nui": ["N0000175937", "M0023650"], "upc": ["0368071163032"], "unii": ["A4P49JAZ9H"], "rxcui": ["242446"], "spl_set_id": ["76f461da-0e15-aa6d-e053-2a91aa0a9808"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 BOTTLE (68071-1630-3)", "package_ndc": "68071-1630-3", "marketing_start_date": "20180928"}], "brand_name": "Ofloxacin Otic", "product_id": "68071-1630_2a2f62dc-8ba6-7ca9-e063-6294a90aca76", "dosage_form": "SOLUTION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "68071-1630", "generic_name": "Ofloxacin", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ofloxacin Otic", "active_ingredients": [{"name": "OFLOXACIN", "strength": "3 mg/mL"}], "application_number": "ANDA076527", "marketing_category": "ANDA", "marketing_start_date": "20040514", "listing_expiration_date": "20261231"}