ciprofloxacin

Generic: ciprofloxacin

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin
Generic Name ciprofloxacin
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ciprofloxacin hydrochloride 500 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-547
Product ID 43063-547_42ef2624-a5bf-f4f7-e063-6294a90a1400
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076126
Listing Expiration 2026-12-31
Marketing Start 2009-10-10

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 43063547
Hyphenated Format 43063-547

Supplemental Identifiers

RxCUI
309309
UPC
0343063547823
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 ANDA076126 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-01)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-20)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-82)
source: ndc

Packages (3)

43063-547-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-01) 43063-547-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-20) 43063-547-82 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-82)

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": "42ef2624-a5bf-f4f7-e063-6294a90a1400", "openfda": {"upc": ["0343063547823"], "unii": ["4BA73M5E37"], "rxcui": ["309309"], "spl_set_id": ["74e2dd24-5c6e-4dde-a2ab-f2d2e61734d8"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-01)", "package_ndc": "43063-547-01", "marketing_start_date": "20190107"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-20)", "package_ndc": "43063-547-20", "marketing_start_date": "20141105"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-547-82)", "package_ndc": "43063-547-82", "marketing_start_date": "20200521"}], "brand_name": "Ciprofloxacin", "product_id": "43063-547_42ef2624-a5bf-f4f7-e063-6294a90a1400", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "43063-547", "generic_name": "Ciprofloxacin", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciprofloxacin", "active_ingredients": [{"name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA076126", "marketing_category": "ANDA", "marketing_start_date": "20091010", "listing_expiration_date": "20261231"}