berkley and jensen ibuprofen (68391-604)

Drug Facts

Product Profile

Brand Name berkley and jensen ibuprofen

Generic Name ibuprofen

Labeler bjwc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

ibuprofen 200 mg/1

Manufacturer

BJWC

Identifiers & Regulatory

Product NDC 68391-604

Product ID 68391-604_75688efe-d8f7-4eb8-99d5-12fbd3015d8f

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA072096

Listing Expiration 2026-12-31

Marketing Start 2007-06-20

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 68391604

Hyphenated Format 68391-604

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 berkley and jensen ibuprofen (source: ndc)

Generic Name ibuprofen (source: ndc)

Application Number ANDA072096 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

200 mg/1

source: ndc

Packaging

500 TABLET, FILM COATED in 1 BOTTLE (68391-604-90)

source: ndc

Packages (1)

68391-604-90 500 TABLET, FILM COATED in 1 BOTTLE (68391-604-90)

Ingredients (1)

ibuprofen (200 mg/1)

Linked Drug Pages (1)

Berkley and Jensen Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "75688efe-d8f7-4eb8-99d5-12fbd3015d8f", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["cda57e42-6106-46ee-82d1-479a692ee5bb"], "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": ["BJWC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (68391-604-90)", "package_ndc": "68391-604-90", "marketing_start_date": "20070620"}], "brand_name": "Berkley and Jensen Ibuprofen", "product_id": "68391-604_75688efe-d8f7-4eb8-99d5-12fbd3015d8f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68391-604", "generic_name": "Ibuprofen", "labeler_name": "BJWC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Berkley and Jensen Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA072096", "marketing_category": "ANDA", "marketing_start_date": "20070620", "listing_expiration_date": "20261231"}