ciprofloxacin

Generic: ciprofloxacin

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

Drug Facts

Product Profile

Brand Name ciprofloxacin
Generic Name ciprofloxacin
Labeler pharmpak, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ciprofloxacin hydrochloride 500 mg/1

Manufacturer
PharmPak, Inc.

Identifiers & Regulatory

Product NDC 54348-663
Product ID 54348-663_ea938ef9-a316-2003-e053-2a95a90aa829
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076639
Listing Expiration 2026-12-31
Marketing Start 2019-07-10

Pharmacologic Class

Classes
quinolone antimicrobial [epc] quinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54348663
Hyphenated Format 54348-663

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 ANDA076639 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (54348-663-01) / 1 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-663-06) / 6 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-663-14) / 14 TABLET in 1 BOTTLE
source: ndc

Packages (3)

54348-663-01 1 BOTTLE in 1 BOX (54348-663-01) / 1 TABLET in 1 BOTTLE 54348-663-06 1 BOTTLE in 1 BOX (54348-663-06) / 6 TABLET in 1 BOTTLE 54348-663-14 1 BOTTLE in 1 BOX (54348-663-14) / 14 TABLET in 1 BOTTLE

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": "ea938ef9-a316-2003-e053-2a95a90aa829", "openfda": {"unii": ["4BA73M5E37"], "rxcui": ["309309"], "spl_set_id": ["6a70db6c-ae68-49e5-8a4a-b5cd1d4840bd"], "manufacturer_name": ["PharmPak, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (54348-663-01)  / 1 TABLET in 1 BOTTLE", "package_ndc": "54348-663-01", "marketing_start_date": "20190710"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-663-06)  / 6 TABLET in 1 BOTTLE", "package_ndc": "54348-663-06", "marketing_start_date": "20190710"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-663-14)  / 14 TABLET in 1 BOTTLE", "package_ndc": "54348-663-14", "marketing_start_date": "20190710"}], "brand_name": "ciprofloxacin", "product_id": "54348-663_ea938ef9-a316-2003-e053-2a95a90aa829", "dosage_form": "TABLET", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "54348-663", "generic_name": "CIPROFLOXACIN", "labeler_name": "PharmPak, Inc.", "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": "20190710", "listing_expiration_date": "20261231"}