topcare dual action back pain

Generic: acetaminophen, ibuprofen

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

Drug Facts

Product Profile

Brand Name topcare dual action back pain
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 76162-520
Product ID 76162-520_8b9580f2-5be1-4484-a45a-b7eba1737134
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA214836
Listing Expiration 2026-12-31
Marketing Start 2024-01-31

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 76162520
Hyphenated Format 76162-520

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 back pain (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 (76162-520-23) / 72 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

76162-520-23 1 BOTTLE in 1 CARTON (76162-520-23) / 72 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

Topcare Dual Action Back Pain ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8b9580f2-5be1-4484-a45a-b7eba1737134", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["362O9ITL9D", "WK2XYI10QM"], "rxcui": ["2387532"], "spl_set_id": ["e40ec21c-6c44-4219-a94f-8b93a4853aa5"], "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 (76162-520-23)  / 72 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "76162-520-23", "marketing_start_date": "20240131"}], "brand_name": "Topcare Dual Action Back Pain", "product_id": "76162-520_8b9580f2-5be1-4484-a45a-b7eba1737134", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "76162-520", "generic_name": "acetaminophen, ibuprofen", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare Dual Action Back Pain", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/1"}, {"name": "IBUPROFEN", "strength": "125 mg/1"}], "application_number": "ANDA214836", "marketing_category": "ANDA", "marketing_start_date": "20240131", "listing_expiration_date": "20261231"}