ciprofloxacin

Generic: ciprofloxacin

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin
Generic Name ciprofloxacin
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ciprofloxacin hydrochloride 750 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1528
Product ID 67046-1528_2fff6ac3-455d-7df0-e063-6394a90a0672
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076639
Listing Expiration 2026-12-31
Marketing Start 2025-03-10

Pharmacologic Class

Classes
cytochrome p450 1a2 inhibitors [moa] fluoroquinolone antibacterial [epc] fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461528
Hyphenated Format 67046-1528

Supplemental Identifiers

RxCUI
197512
UNII
4BA73M5E37

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 ciprofloxacin (source: ndc)
Generic Name ciprofloxacin (source: ndc)
Application Number ANDA076639 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1528-3)
source: ndc

Packages (1)

67046-1528-3 30 TABLET in 1 BLISTER PACK (67046-1528-3)

Ingredients (1)

ciprofloxacin hydrochloride (750 mg/1)

Linked Drug Pages (1)

ciprofloxacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2fff6ac3-455d-7df0-e063-6394a90a0672", "openfda": {"unii": ["4BA73M5E37"], "rxcui": ["197512"], "spl_set_id": ["2fff7a38-2c4e-d343-e063-6294a90aca3c"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1528-3)", "package_ndc": "67046-1528-3", "marketing_start_date": "20250310"}], "brand_name": "ciprofloxacin", "product_id": "67046-1528_2fff6ac3-455d-7df0-e063-6394a90a0672", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "67046-1528", "generic_name": "ciprofloxacin", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ciprofloxacin", "active_ingredients": [{"name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "750 mg/1"}], "application_number": "ANDA076639", "marketing_category": "ANDA", "marketing_start_date": "20250310", "listing_expiration_date": "20261231"}