cipro

Generic: ciprofloxacin hydrochloride

Labeler: bayer healthcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cipro
Generic Name ciprofloxacin hydrochloride
Labeler bayer healthcare pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ciprofloxacin hydrochloride 500 mg/1

Manufacturer
Bayer HealthCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 50419-754
Product ID 50419-754_1b112839-6cf0-466a-9188-86fc5b1549f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019537
Listing Expiration 2027-12-31
Marketing Start 1987-10-22

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 50419754
Hyphenated Format 50419-754

Supplemental Identifiers

RxCUI
197511 205769 205770 213224 213226 309308 309309 309310
UPC
0350419754019 0350419758017
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 cipro (source: ndc)
Generic Name ciprofloxacin hydrochloride (source: ndc)
Application Number NDA019537 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-754-01)
source: ndc

Packages (1)

50419-754-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-754-01)

Ingredients (1)

ciprofloxacin hydrochloride (500 mg/1)

Linked Drug Pages (1)

Cipro ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1b112839-6cf0-466a-9188-86fc5b1549f9", "openfda": {"upc": ["0350419754019", "0350419758017"], "unii": ["4BA73M5E37"], "rxcui": ["197511", "205769", "205770", "213224", "213226", "309308", "309309", "309310"], "spl_set_id": ["888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-754-01)", "package_ndc": "50419-754-01", "marketing_start_date": "19871022"}], "brand_name": "Cipro", "product_id": "50419-754_1b112839-6cf0-466a-9188-86fc5b1549f9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "50419-754", "generic_name": "ciprofloxacin hydrochloride", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cipro", "active_ingredients": [{"name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "NDA019537", "marketing_category": "NDA", "marketing_start_date": "19871022", "listing_expiration_date": "20271231"}