ibuprofen

Generic: ibuprofen

Labeler: humanwell puracap pharmaceutical (wuhan) co., ltd
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler humanwell puracap pharmaceutical (wuhan) co., ltd
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd

Identifiers & Regulatory

Product NDC 53345-039
Product ID 53345-039_8748389d-27ff-47b5-bbe9-03592e2d7d45
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206568
Listing Expiration 2026-12-31
Marketing Start 2017-07-13

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 53345039
Hyphenated Format 53345-039

Supplemental Identifiers

RxCUI
310964
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 ANDA206568 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 24 BOTTLE in 1 BOX (53345-039-02) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • 100 BOTTLE in 1 BOX (53345-039-03) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE
source: ndc

Packages (2)

53345-039-02 24 BOTTLE in 1 BOX (53345-039-02) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE 53345-039-03 100 BOTTLE in 1 BOX (53345-039-03) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE

Ingredients (1)

ibuprofen (200 mg/1)

Linked Drug Pages (2)

Ibuprofen ndc-match (0.9) Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8748389d-27ff-47b5-bbe9-03592e2d7d45", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["310964"], "spl_set_id": ["f42506f7-896c-47a9-a4b1-ed72434d7aa0"], "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": ["Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BOTTLE in 1 BOX (53345-039-02)  / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "53345-039-02", "marketing_start_date": "20170713"}, {"sample": false, "description": "100 BOTTLE in 1 BOX (53345-039-03)  / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "53345-039-03", "marketing_start_date": "20170713"}], "brand_name": "Ibuprofen", "product_id": "53345-039_8748389d-27ff-47b5-bbe9-03592e2d7d45", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "53345-039", "generic_name": "Ibuprofen", "labeler_name": "Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA206568", "marketing_category": "ANDA", "marketing_start_date": "20170713", "listing_expiration_date": "20261231"}