ibuprofen

Generic: ibuprofen

Labeler: spirit pharmaceutical llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler spirit pharmaceutical llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
Spirit Pharmaceutical LLC

Identifiers & Regulatory

Product NDC 68210-8100
Product ID 68210-8100_2a81131c-e4d7-6084-e063-6394a90a8100
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079174
Listing Expiration 2026-12-31
Marketing Start 2020-03-10

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 682108100
Hyphenated Format 68210-8100

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 (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 (68210-8100-2) / 25 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (68210-8100-3) / 30 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (68210-8100-5) / 50 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (3)

68210-8100-2 1 BOTTLE in 1 CARTON (68210-8100-2) / 25 TABLET, FILM COATED in 1 BOTTLE 68210-8100-3 1 BOTTLE in 1 CARTON (68210-8100-3) / 30 TABLET, FILM COATED in 1 BOTTLE 68210-8100-5 1 BOTTLE in 1 CARTON (68210-8100-5) / 50 TABLET, FILM COATED in 1 BOTTLE

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": "2a81131c-e4d7-6084-e063-6394a90a8100", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["a96d012e-b132-4e99-b84b-ccd3a9a05cbb"], "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": ["Spirit Pharmaceutical LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68210-8100-2)  / 25 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "68210-8100-2", "marketing_start_date": "20200922"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (68210-8100-3)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "68210-8100-3", "marketing_start_date": "20200310"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (68210-8100-5)  / 50 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "68210-8100-5", "marketing_start_date": "20200310"}], "brand_name": "Ibuprofen", "product_id": "68210-8100_2a81131c-e4d7-6084-e063-6394a90a8100", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68210-8100", "generic_name": "Ibuprofen", "labeler_name": "Spirit Pharmaceutical LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA079174", "marketing_category": "ANDA", "marketing_start_date": "20200310", "listing_expiration_date": "20261231"}