ibuprofen 200mg

Generic: ibuprofen

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

Drug Facts

Product Profile

Brand Name ibuprofen 200mg
Generic Name ibuprofen
Labeler allegiant health
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
Allegiant Health

Identifiers & Regulatory

Product NDC 69168-381
Product ID 69168-381_ccb176fa-b1be-4552-ab01-c8a0643e063c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079174
Listing Expiration 2026-12-31
Marketing Start 2021-11-16

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 69168381
Hyphenated Format 69168-381

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 200mg (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA079174 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (69168-381-01) / 100 TABLET in 1 BOTTLE
  • 250 TABLET in 1 BOTTLE (69168-381-03)
  • 500 TABLET in 1 BOTTLE (69168-381-05)
  • 1 BOTTLE in 1 CARTON (69168-381-30) / 30 TABLET in 1 BOTTLE
  • 100 TABLET in 1 BOTTLE (69168-381-32)
  • 1 BOTTLE in 1 CARTON (69168-381-40) / 40 TABLET in 1 BOTTLE
source: ndc

Packages (6)

69168-381-01 1 BOTTLE in 1 CARTON (69168-381-01) / 100 TABLET in 1 BOTTLE 69168-381-03 250 TABLET in 1 BOTTLE (69168-381-03) 69168-381-05 500 TABLET in 1 BOTTLE (69168-381-05) 69168-381-30 1 BOTTLE in 1 CARTON (69168-381-30) / 30 TABLET in 1 BOTTLE 69168-381-32 100 TABLET in 1 BOTTLE (69168-381-32) 69168-381-40 1 BOTTLE in 1 CARTON (69168-381-40) / 40 TABLET in 1 BOTTLE

Ingredients (1)

ibuprofen (200 mg/1)

Linked Drug Pages (1)

Ibuprofen 200mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ccb176fa-b1be-4552-ab01-c8a0643e063c", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["f3f12b86-89dc-427e-a26f-728be6f73e7b"], "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": ["Allegiant Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69168-381-01)  / 100 TABLET in 1 BOTTLE", "package_ndc": "69168-381-01", "marketing_start_date": "20211116"}, {"sample": false, "description": "250 TABLET in 1 BOTTLE (69168-381-03)", "package_ndc": "69168-381-03", "marketing_start_date": "20211116"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69168-381-05)", "package_ndc": "69168-381-05", "marketing_start_date": "20211116"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69168-381-30)  / 30 TABLET in 1 BOTTLE", "package_ndc": "69168-381-30", "marketing_start_date": "20211116"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (69168-381-32)", "package_ndc": "69168-381-32", "marketing_start_date": "20220518"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69168-381-40)  / 40 TABLET in 1 BOTTLE", "package_ndc": "69168-381-40", "marketing_start_date": "20211116"}], "brand_name": "Ibuprofen 200mg", "product_id": "69168-381_ccb176fa-b1be-4552-ab01-c8a0643e063c", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69168-381", "generic_name": "Ibuprofen", "labeler_name": "Allegiant Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen 200mg", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA079174", "marketing_category": "ANDA", "marketing_start_date": "20211116", "listing_expiration_date": "20261231"}