ibuprofen

Generic: ibuprofen

Labeler: chain drug marketing association inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler chain drug marketing association inc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
CHAIN DRUG MARKETING ASSOCIATION INC

Identifiers & Regulatory

Product NDC 63868-570
Product ID 63868-570_459b3c6b-39d6-a4d6-e063-6394a90a9350
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA202312
Marketing Start 2020-03-25
Marketing End 2027-04-30

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 63868570
Hyphenated Format 63868-570

Supplemental Identifiers

RxCUI
310965
UPC
0635515985278
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 ANDA202312 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (63868-570-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (63868-570-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

63868-570-01 1 BOTTLE, PLASTIC in 1 CARTON (63868-570-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 63868-570-50 1 BOTTLE, PLASTIC in 1 CARTON (63868-570-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC

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": "459b3c6b-39d6-a4d6-e063-6394a90a9350", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0635515985278"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["9c1ded4e-1d3b-1ab6-e053-2995a90aa80d"], "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": ["CHAIN DRUG MARKETING ASSOCIATION INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (63868-570-01)  / 100 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "63868-570-01", "marketing_end_date": "20270430", "marketing_start_date": "20200515"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (63868-570-50)  / 50 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "63868-570-50", "marketing_end_date": "20261031", "marketing_start_date": "20200325"}], "brand_name": "Ibuprofen", "product_id": "63868-570_459b3c6b-39d6-a4d6-e063-6394a90a9350", "dosage_form": "TABLET, COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "63868-570", "generic_name": "Ibuprofen", "labeler_name": "CHAIN DRUG MARKETING ASSOCIATION INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA202312", "marketing_category": "ANDA", "marketing_end_date": "20270430", "marketing_start_date": "20200325"}