ibuprofen

Generic: ibuprofen

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler aurohealth llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-802
Product ID 58602-802_5e6a6cce-b25c-4d6c-9d58-b4db175c6f8e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208865
Listing Expiration 2026-12-31
Marketing Start 2017-11-08

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 58602802
Hyphenated Format 58602-802

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 ibuprofen (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA208865 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (58602-802-07) / 24 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-802-14) / 50 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-802-21) / 100 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-802-29) / 150 TABLET in 1 BOTTLE
  • 200 TABLET in 1 BOTTLE (58602-802-34)
  • 300 TABLET in 1 BOTTLE (58602-802-38)
source: ndc

Packages (6)

58602-802-07 1 BOTTLE in 1 CARTON (58602-802-07) / 24 TABLET in 1 BOTTLE 58602-802-14 1 BOTTLE in 1 CARTON (58602-802-14) / 50 TABLET in 1 BOTTLE 58602-802-21 1 BOTTLE in 1 CARTON (58602-802-21) / 100 TABLET in 1 BOTTLE 58602-802-29 1 BOTTLE in 1 CARTON (58602-802-29) / 150 TABLET in 1 BOTTLE 58602-802-34 200 TABLET in 1 BOTTLE (58602-802-34) 58602-802-38 300 TABLET in 1 BOTTLE (58602-802-38)

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": "5e6a6cce-b25c-4d6c-9d58-b4db175c6f8e", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["cf6fbf3b-a0f3-4e08-a981-d183fa285758"], "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": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-802-07)  / 24 TABLET in 1 BOTTLE", "package_ndc": "58602-802-07", "marketing_start_date": "20171108"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-802-14)  / 50 TABLET in 1 BOTTLE", "package_ndc": "58602-802-14", "marketing_start_date": "20171108"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-802-21)  / 100 TABLET in 1 BOTTLE", "package_ndc": "58602-802-21", "marketing_start_date": "20171108"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-802-29)  / 150 TABLET in 1 BOTTLE", "package_ndc": "58602-802-29", "marketing_start_date": "20171108"}, {"sample": false, "description": "200 TABLET in 1 BOTTLE (58602-802-34)", "package_ndc": "58602-802-34", "marketing_start_date": "20171108"}, {"sample": false, "description": "300 TABLET in 1 BOTTLE (58602-802-38)", "package_ndc": "58602-802-38", "marketing_start_date": "20171108"}], "brand_name": "Ibuprofen", "product_id": "58602-802_5e6a6cce-b25c-4d6c-9d58-b4db175c6f8e", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "58602-802", "generic_name": "Ibuprofen", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA208865", "marketing_category": "ANDA", "marketing_start_date": "20171108", "listing_expiration_date": "20261231"}