ibuprofen 200mg

Generic: ibuprofen 200mg

Labeler: athlete's needs, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen 200mg
Generic Name ibuprofen 200mg
Labeler athlete's needs, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
Athlete's Needs, Inc.

Identifiers & Regulatory

Product NDC 53185-381
Product ID 53185-381_9925c48b-f4aa-4393-b877-84307eb271e1
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA202312
Listing Expiration 2026-12-31
Marketing Start 2016-10-07

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 53185381
Hyphenated Format 53185-381

Supplemental Identifiers

RxCUI
310965
UPC
0092617275414
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 200mg (source: ndc)
Application Number ANDA202312 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (53185-381-01)
source: ndc

Packages (1)

53185-381-01 100 TABLET, COATED in 1 BOTTLE (53185-381-01)

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": "9925c48b-f4aa-4393-b877-84307eb271e1", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0092617275414"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["2db10105-6fd3-420d-8889-7cfd6f396e5f"], "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": ["Athlete's Needs, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (53185-381-01)", "package_ndc": "53185-381-01", "marketing_start_date": "20161007"}], "brand_name": "Ibuprofen 200mg", "product_id": "53185-381_9925c48b-f4aa-4393-b877-84307eb271e1", "dosage_form": "TABLET, COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "53185-381", "generic_name": "Ibuprofen 200mg", "labeler_name": "Athlete's Needs, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen 200mg", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA202312", "marketing_category": "ANDA", "marketing_start_date": "20161007", "listing_expiration_date": "20261231"}