leader ibuprofen

Generic: ibuprofen

Labeler: cardinal health 110, llc. dba leader
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leader ibuprofen
Generic Name ibuprofen
Labeler cardinal health 110, llc. dba leader
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0175
Product ID 70000-0175_2235a36b-14ac-4a95-8616-6d51f2ce5c1f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA072096
Listing Expiration 2027-12-31
Marketing Start 2016-11-30

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000175
Hyphenated Format 70000-0175

Supplemental Identifiers

RxCUI
310965
UNII
WK2XYI10QM
NUI
N0000000160 M0001335 N0000175722

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 leader ibuprofen (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA072096 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70000-0175-1) / 24 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (70000-0175-2) / 50 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (70000-0175-3) / 100 TABLET, FILM COATED in 1 BOTTLE
  • 500 TABLET, FILM COATED in 1 BOTTLE (70000-0175-5)
  • 1 BOTTLE in 1 CARTON (70000-0175-8) / 200 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (70000-0175-9) / 250 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (6)

70000-0175-1 1 BOTTLE in 1 CARTON (70000-0175-1) / 24 TABLET, FILM COATED in 1 BOTTLE 70000-0175-2 1 BOTTLE in 1 CARTON (70000-0175-2) / 50 TABLET, FILM COATED in 1 BOTTLE 70000-0175-3 1 BOTTLE in 1 CARTON (70000-0175-3) / 100 TABLET, FILM COATED in 1 BOTTLE 70000-0175-5 500 TABLET, FILM COATED in 1 BOTTLE (70000-0175-5) 70000-0175-8 1 BOTTLE in 1 CARTON (70000-0175-8) / 200 TABLET, FILM COATED in 1 BOTTLE 70000-0175-9 1 BOTTLE in 1 CARTON (70000-0175-9) / 250 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

ibuprofen (200 mg/1)

Linked Drug Pages (1)

Leader Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2235a36b-14ac-4a95-8616-6d51f2ce5c1f", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["d673266c-3d2b-479f-9b53-cdd1b8651393"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Cardinal Health 110, LLC. dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0175-1)  / 24 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "70000-0175-1", "marketing_start_date": "20161130"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0175-2)  / 50 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "70000-0175-2", "marketing_start_date": "20170429"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0175-3)  / 100 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "70000-0175-3", "marketing_start_date": "20170504"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (70000-0175-5)", "package_ndc": "70000-0175-5", "marketing_start_date": "20170523"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0175-8)  / 200 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "70000-0175-8", "marketing_start_date": "20211001"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0175-9)  / 250 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "70000-0175-9", "marketing_end_date": "20261031", "marketing_start_date": "20240129"}], "brand_name": "Leader Ibuprofen", "product_id": "70000-0175_2235a36b-14ac-4a95-8616-6d51f2ce5c1f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "70000-0175", "generic_name": "Ibuprofen", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Leader Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA072096", "marketing_category": "ANDA", "marketing_start_date": "20161130", "listing_expiration_date": "20271231"}