ciprofloxacin

Generic: ciprofloxacin

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin
Generic Name ciprofloxacin
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ciprofloxacin hydrochloride 500 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7243
Product ID 0904-7243_ec371e89-c5cc-4142-a3b6-38297f9b6dc3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076639
Listing Expiration 2027-12-31
Marketing Start 2022-08-23

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 09047243
Hyphenated Format 0904-7243

Supplemental Identifiers

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
  • 500 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7243-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 20 TABLET, FILM COATED in 1 BOTTLE (0904-7243-95)
source: ndc

Packages (2)

0904-7243-61 100 BLISTER PACK in 1 CARTON (0904-7243-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK 0904-7243-95 20 TABLET, FILM COATED in 1 BOTTLE (0904-7243-95)

Ingredients (1)

ciprofloxacin hydrochloride (500 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": "ec371e89-c5cc-4142-a3b6-38297f9b6dc3", "openfda": {"unii": ["4BA73M5E37"], "spl_set_id": ["f818ed31-c746-4171-afdf-57a75434e5f1"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7243-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-7243-61", "marketing_start_date": "20220823"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (0904-7243-95)", "package_ndc": "0904-7243-95", "marketing_start_date": "20220823"}], "brand_name": "ciprofloxacin", "product_id": "0904-7243_ec371e89-c5cc-4142-a3b6-38297f9b6dc3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "0904-7243", "generic_name": "ciprofloxacin", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ciprofloxacin", "active_ingredients": [{"name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA076639", "marketing_category": "ANDA", "marketing_start_date": "20220823", "listing_expiration_date": "20271231"}