ibuprofen

Generic: ibuprofen

Labeler: bjwc (berkley & jensen / bj's)
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler bjwc (berkley & jensen / bj's)
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
BJWC (Berkley & Jensen / BJ's)

Identifiers & Regulatory

Product NDC 68391-610
Product ID 68391-610_3bea9ca5-0429-e937-e063-6394a90a07c8
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079205
Listing Expiration 2026-12-31
Marketing Start 2025-08-20

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 68391610
Hyphenated Format 68391-610

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 ANDA079205 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 480 CAPSULE, LIQUID FILLED in 1 BOTTLE (68391-610-99)
source: ndc

Packages (1)

68391-610-99 480 CAPSULE, LIQUID FILLED in 1 BOTTLE (68391-610-99)

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": "3bea9ca5-0429-e937-e063-6394a90a07c8", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["310964"], "spl_set_id": ["2f322afb-bfc8-9dab-e063-6394a90a08b5"], "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 (Berkley & Jensen / BJ's)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "480 CAPSULE, LIQUID FILLED in 1 BOTTLE (68391-610-99)", "package_ndc": "68391-610-99", "marketing_start_date": "20250820"}], "brand_name": "Ibuprofen", "product_id": "68391-610_3bea9ca5-0429-e937-e063-6394a90a07c8", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68391-610", "generic_name": "Ibuprofen", "labeler_name": "BJWC (Berkley & Jensen / BJ's)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA079205", "marketing_category": "ANDA", "marketing_start_date": "20250820", "listing_expiration_date": "20261231"}