ciprofloxacin

Generic: ciprofloxacin

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin
Generic Name ciprofloxacin
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ciprofloxacin hydrochloride 500 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3063
Product ID 70518-3063_4ab50ad6-9813-7ab0-e063-6294a90af6c7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076558
Listing Expiration 2027-12-31
Marketing Start 2021-04-02

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 705183063
Hyphenated Format 70518-3063

Supplemental Identifiers

RxCUI
309309
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 ANDA076558 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3063-5)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3063-6)
source: ndc

Packages (2)

70518-3063-5 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3063-5) 70518-3063-6 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3063-6)

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": "4ab50ad6-9813-7ab0-e063-6294a90af6c7", "openfda": {"unii": ["4BA73M5E37"], "rxcui": ["309309"], "spl_set_id": ["44b6cefc-7638-4437-95e7-8f239f66a9d4"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3063-5)", "package_ndc": "70518-3063-5", "marketing_start_date": "20220509"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3063-6)", "package_ndc": "70518-3063-6", "marketing_start_date": "20220804"}], "brand_name": "Ciprofloxacin", "product_id": "70518-3063_4ab50ad6-9813-7ab0-e063-6294a90af6c7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "70518-3063", "generic_name": "Ciprofloxacin", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciprofloxacin", "active_ingredients": [{"name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA076558", "marketing_category": "ANDA", "marketing_start_date": "20210402", "listing_expiration_date": "20271231"}