topcare ibuprofen

Generic: ibuprofen

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topcare ibuprofen
Generic Name ibuprofen
Labeler topco associates llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-647
Product ID 36800-647_02993180-71f3-4807-bc0d-45d10238c7a8
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA072096
Listing Expiration 2026-12-31
Marketing Start 1988-11-15

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 36800647
Hyphenated Format 36800-647

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 topcare ibuprofen (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA072096 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (36800-647-62) / 24 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (36800-647-71) / 50 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (36800-647-78) / 100 TABLET, FILM COATED in 1 BOTTLE
  • 500 TABLET, FILM COATED in 1 BOTTLE (36800-647-90)
source: ndc

Packages (4)

36800-647-62 1 BOTTLE in 1 CARTON (36800-647-62) / 24 TABLET, FILM COATED in 1 BOTTLE 36800-647-71 1 BOTTLE in 1 CARTON (36800-647-71) / 50 TABLET, FILM COATED in 1 BOTTLE 36800-647-78 1 BOTTLE in 1 CARTON (36800-647-78) / 100 TABLET, FILM COATED in 1 BOTTLE 36800-647-90 500 TABLET, FILM COATED in 1 BOTTLE (36800-647-90)

Ingredients (1)

ibuprofen (200 mg/1)

Linked Drug Pages (1)

Topcare Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "02993180-71f3-4807-bc0d-45d10238c7a8", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["8be375b0-c729-49de-abc5-2e7d37144b89"], "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": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-647-62)  / 24 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "36800-647-62", "marketing_start_date": "20060428"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-647-71)  / 50 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "36800-647-71", "marketing_start_date": "19881115"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-647-78)  / 100 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "36800-647-78", "marketing_start_date": "19911002"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (36800-647-90)", "package_ndc": "36800-647-90", "marketing_start_date": "20031120"}], "brand_name": "Topcare Ibuprofen", "product_id": "36800-647_02993180-71f3-4807-bc0d-45d10238c7a8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "36800-647", "generic_name": "Ibuprofen", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA072096", "marketing_category": "ANDA", "marketing_start_date": "19881115", "listing_expiration_date": "20261231"}