ibuprofen

Generic: ibuprofen

Labeler: cardinal health
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler cardinal health
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
CARDINAL HEALTH

Identifiers & Regulatory

Product NDC 70000-0597
Product ID 70000-0597_dfbbde4f-633e-6d57-e053-2a95a90ad82f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091237
Listing Expiration 2026-12-31
Marketing Start 2022-05-25

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 700000597
Hyphenated Format 70000-0597

Supplemental Identifiers

RxCUI
310965
UPC
0096295141870 0096295141863
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 ibuprofen (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA091237 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70000-0597-1) / 50 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (70000-0597-2) / 100 TABLET in 1 BOTTLE
source: ndc

Packages (2)

70000-0597-1 1 BOTTLE in 1 CARTON (70000-0597-1) / 50 TABLET in 1 BOTTLE 70000-0597-2 1 BOTTLE in 1 CARTON (70000-0597-2) / 100 TABLET in 1 BOTTLE

Ingredients (1)

ibuprofen (200 mg/1)

Linked Drug Pages (1)

Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "dfbbde4f-633e-6d57-e053-2a95a90ad82f", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0096295141870", "0096295141863"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["dfbbde4f-633d-6d57-e053-2a95a90ad82f"], "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"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0597-1)  / 50 TABLET in 1 BOTTLE", "package_ndc": "70000-0597-1", "marketing_start_date": "20220525"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0597-2)  / 100 TABLET in 1 BOTTLE", "package_ndc": "70000-0597-2", "marketing_start_date": "20220525"}], "brand_name": "Ibuprofen", "product_id": "70000-0597_dfbbde4f-633e-6d57-e053-2a95a90ad82f", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "70000-0597", "generic_name": "Ibuprofen", "labeler_name": "CARDINAL HEALTH", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA091237", "marketing_category": "ANDA", "marketing_start_date": "20220525", "listing_expiration_date": "20261231"}