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 SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0264
Product ID 70000-0264_b245c1c7-1add-4087-8ae8-ff5b3f46183d
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074937
Listing Expiration 2026-12-31
Marketing Start 2017-04-05

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 700000264
Hyphenated Format 70000-0264

Supplemental Identifiers

RxCUI
197803
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 ANDA074937 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70000-0264-1) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

70000-0264-1 1 BOTTLE in 1 CARTON (70000-0264-1) / 120 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

leader Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b245c1c7-1add-4087-8ae8-ff5b3f46183d", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["009dde4c-d944-4206-8c9f-35bc8fd92715"], "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 (70000-0264-1)  / 120 mL in 1 BOTTLE", "package_ndc": "70000-0264-1", "marketing_start_date": "20170405"}], "brand_name": "leader Ibuprofen", "product_id": "70000-0264_b245c1c7-1add-4087-8ae8-ff5b3f46183d", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "70000-0264", "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": "100 mg/5mL"}], "application_number": "ANDA074937", "marketing_category": "ANDA", "marketing_start_date": "20170405", "listing_expiration_date": "20261231"}