assured ibuprofen

Generic: ibuprofen

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

Drug Facts

Product Profile

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

ibuprofen 200 mg/1

Manufacturer
Spirit Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 68210-4139
Product ID 68210-4139_28ef5535-36c5-ed54-e063-6394a90aefc6
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA202312
Listing Expiration 2026-12-31
Marketing Start 2019-02-25

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 682104139
Hyphenated Format 68210-4139

Supplemental Identifiers

RxCUI
310965
UPC
0850026889123
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 assured ibuprofen (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA202312 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68210-4139-4) / 40 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

68210-4139-4 1 BOTTLE in 1 CARTON (68210-4139-4) / 40 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

ibuprofen (200 mg/1)

Linked Drug Pages (1)

Assured Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "28ef5535-36c5-ed54-e063-6394a90aefc6", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0850026889123"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["119263b5-c3b7-46dc-a3bd-9893bfd24628"], "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 Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68210-4139-4)  / 40 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "68210-4139-4", "marketing_start_date": "20210428"}], "brand_name": "Assured Ibuprofen", "product_id": "68210-4139_28ef5535-36c5-ed54-e063-6394a90aefc6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68210-4139", "generic_name": "Ibuprofen", "labeler_name": "Spirit Pharmaceuticals LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Assured Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA202312", "marketing_category": "ANDA", "marketing_start_date": "20190225", "listing_expiration_date": "20261231"}