topcare dual action (76162-501)

Drug Facts

Product Profile

Brand Name topcare dual action

Generic Name acetaminophen, ibuprofen

Labeler topco associates llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

acetaminophen 250 mg/1, ibuprofen 125 mg/1

Manufacturer

Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-501

Product ID 76162-501_45a4d44d-ba32-4aec-8eaf-9665cb6fb08b

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA214836

Listing Expiration 2026-12-31

Marketing Start 2023-03-06

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 76162501

Hyphenated Format 76162-501

Supplemental Identifiers

RxCUI

2387532

UNII

362O9ITL9D 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 dual action (source: ndc)

Generic Name acetaminophen, ibuprofen (source: ndc)

Application Number ANDA214836 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

250 mg/1
125 mg/1

source: ndc

Packaging

1 BOTTLE in 1 CARTON (76162-501-16) / 144 TABLET, FILM COATED in 1 BOTTLE
1 BOTTLE in 1 CARTON (76162-501-23) / 72 TABLET, FILM COATED in 1 BOTTLE
1 BOTTLE in 1 CARTON (76162-501-68) / 36 TABLET, FILM COATED in 1 BOTTLE

source: ndc

Packages (3)

76162-501-16 1 BOTTLE in 1 CARTON (76162-501-16) / 144 TABLET, FILM COATED in 1 BOTTLE 76162-501-23 1 BOTTLE in 1 CARTON (76162-501-23) / 72 TABLET, FILM COATED in 1 BOTTLE 76162-501-68 1 BOTTLE in 1 CARTON (76162-501-68) / 36 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

acetaminophen (250 mg/1) ibuprofen (125 mg/1)

Linked Drug Pages (1)

topcare dual action ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "45a4d44d-ba32-4aec-8eaf-9665cb6fb08b", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["362O9ITL9D", "WK2XYI10QM"], "rxcui": ["2387532"], "spl_set_id": ["dddc04c4-d500-4d42-8406-89f27a9ad651"], "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 (76162-501-16)  / 144 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "76162-501-16", "marketing_start_date": "20230306"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (76162-501-23)  / 72 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "76162-501-23", "marketing_start_date": "20230306"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (76162-501-68)  / 36 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "76162-501-68", "marketing_start_date": "20230306"}], "brand_name": "topcare dual action", "product_id": "76162-501_45a4d44d-ba32-4aec-8eaf-9665cb6fb08b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "76162-501", "generic_name": "Acetaminophen, Ibuprofen", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare dual action", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/1"}, {"name": "IBUPROFEN", "strength": "125 mg/1"}], "application_number": "ANDA214836", "marketing_category": "ANDA", "marketing_start_date": "20230306", "listing_expiration_date": "20261231"}