ciprofloxacin

Generic: ciprofloxacin hydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin
Generic Name ciprofloxacin hydrochloride
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ciprofloxacin hydrochloride 750 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-978
Product ID 59651-978_1b0919a9-bcfc-4e58-b084-0454bf244665
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077859
Listing Expiration 2026-12-31
Marketing Start 2025-03-27

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 59651978
Hyphenated Format 59651-978

Supplemental Identifiers

RxCUI
197511 197512 309309
UPC
0359651976302
UNII
4BA73M5E37

Packaging Origin

Original Packager
true

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 hydrochloride (source: ndc)
Application Number ANDA077859 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (59651-978-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (59651-978-05)
  • 20 TABLET, FILM COATED in 1 BOTTLE (59651-978-20)
  • 50 TABLET, FILM COATED in 1 BOTTLE (59651-978-50)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (59651-978-98)
source: ndc

Packages (5)

59651-978-01 100 TABLET, FILM COATED in 1 BOTTLE (59651-978-01) 59651-978-05 500 TABLET, FILM COATED in 1 BOTTLE (59651-978-05) 59651-978-20 20 TABLET, FILM COATED in 1 BOTTLE (59651-978-20) 59651-978-50 50 TABLET, FILM COATED in 1 BOTTLE (59651-978-50) 59651-978-98 1000 TABLET, FILM COATED in 1 BOTTLE (59651-978-98)

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": "1b0919a9-bcfc-4e58-b084-0454bf244665", "openfda": {"upc": ["0359651976302"], "unii": ["4BA73M5E37"], "rxcui": ["197511", "197512", "309309"], "spl_set_id": ["6a935846-3c97-4517-bc4e-2377f673285e"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (59651-978-01)", "package_ndc": "59651-978-01", "marketing_start_date": "20250327"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (59651-978-05)", "package_ndc": "59651-978-05", "marketing_start_date": "20250327"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (59651-978-20)", "package_ndc": "59651-978-20", "marketing_start_date": "20250327"}, {"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (59651-978-50)", "package_ndc": "59651-978-50", "marketing_start_date": "20250327"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (59651-978-98)", "package_ndc": "59651-978-98", "marketing_start_date": "20250327"}], "brand_name": "Ciprofloxacin", "product_id": "59651-978_1b0919a9-bcfc-4e58-b084-0454bf244665", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "59651-978", "generic_name": "Ciprofloxacin Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciprofloxacin", "active_ingredients": [{"name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "750 mg/1"}], "application_number": "ANDA077859", "marketing_category": "ANDA", "marketing_start_date": "20250327", "listing_expiration_date": "20261231"}