ibuprofen

Generic: ibuprofen

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

Drug Facts

Product Profile

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

ibuprofen 400 mg/1

Manufacturer
TIME CAP LABORATORIES, INC

Identifiers & Regulatory

Product NDC 49483-602
Product ID 49483-602_27b8b074-c62d-7214-e063-6294a90adb69
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090796
Listing Expiration 2026-12-31
Marketing Start 2015-12-30

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 49483602
Hyphenated Format 49483-602

Supplemental Identifiers

RxCUI
197805 197806 197807
UPC
0349483604504 0349483604016 0349483602012 0349483602500 0349483603507 0349483603019
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 ANDA090796 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (49483-602-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (49483-602-50)
source: ndc

Packages (2)

49483-602-01 100 TABLET, FILM COATED in 1 BOTTLE (49483-602-01) 49483-602-50 500 TABLET, FILM COATED in 1 BOTTLE (49483-602-50)

Ingredients (1)

ibuprofen (400 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": "27b8b074-c62d-7214-e063-6294a90adb69", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0349483604504", "0349483604016", "0349483602012", "0349483602500", "0349483603507", "0349483603019"], "unii": ["WK2XYI10QM"], "rxcui": ["197805", "197806", "197807"], "spl_set_id": ["ec3e8443-d742-4c25-8516-f0df4ebfccdc"], "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 (49483-602-01)", "package_ndc": "49483-602-01", "marketing_start_date": "20151230"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (49483-602-50)", "package_ndc": "49483-602-50", "marketing_start_date": "20151230"}], "brand_name": "Ibuprofen", "product_id": "49483-602_27b8b074-c62d-7214-e063-6294a90adb69", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "49483-602", "generic_name": "Ibuprofen", "labeler_name": "TIME CAP LABORATORIES, INC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "400 mg/1"}], "application_number": "ANDA090796", "marketing_category": "ANDA", "marketing_start_date": "20151230", "listing_expiration_date": "20261231"}