ibuprofen

Generic: ibupfrofen

Labeler: time cap laboratories,inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibupfrofen
Labeler time cap laboratories,inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
TIME CAP LABORATORIES,INC

Identifiers & Regulatory

Product NDC 49483-600
Product ID 49483-600_375d8923-4e92-d631-e063-6294a90a20eb
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091239
Listing Expiration 2026-12-31
Marketing Start 2016-03-22

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 49483600
Hyphenated Format 49483-600

Supplemental Identifiers

RxCUI
310965
UPC
0349483600018 0349483601015 0349483600056 0349483114171 0349483600506
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 ibupfrofen (source: ndc)
Application Number ANDA091239 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (49483-600-01)
  • 50 TABLET, FILM COATED in 1 BOTTLE (49483-600-05)
  • 500 TABLET, FILM COATED in 1 BOTTLE (49483-600-50)
source: ndc

Packages (3)

49483-600-01 100 TABLET, FILM COATED in 1 BOTTLE (49483-600-01) 49483-600-05 50 TABLET, FILM COATED in 1 BOTTLE (49483-600-05) 49483-600-50 500 TABLET, FILM COATED in 1 BOTTLE (49483-600-50)

Ingredients (1)

ibuprofen (200 mg/1)

Linked Drug Pages (1)

Ibuprofen, IBUPROFEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "375d8923-4e92-d631-e063-6294a90a20eb", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0349483600018", "0349483601015", "0349483600056", "0349483114171", "0349483600506"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["f58d35f9-e44b-417b-98ce-0766b537cd2f"], "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": ["TIME CAP LABORATORIES,INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (49483-600-01)", "package_ndc": "49483-600-01", "marketing_start_date": "20160322"}, {"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (49483-600-05)", "package_ndc": "49483-600-05", "marketing_start_date": "20160322"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (49483-600-50)", "package_ndc": "49483-600-50", "marketing_start_date": "20171114"}], "brand_name": "IBUPROFEN", "product_id": "49483-600_375d8923-4e92-d631-e063-6294a90a20eb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "49483-600", "generic_name": "IBUPFROFEN", "labeler_name": "TIME CAP LABORATORIES,INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "IBUPROFEN", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA091239", "marketing_category": "ANDA", "marketing_start_date": "20160322", "listing_expiration_date": "20261231"}