topcare 8 hr arthritis pain relief

Generic: acetaminophen

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

Drug Facts

Product Profile

Brand Name topcare 8 hr arthritis pain relief
Generic Name acetaminophen
Labeler topco associates llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-455
Product ID 36800-455_6be40153-a08e-4a37-8416-75167ab0efa6
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075077
Listing Expiration 2026-12-31
Marketing Start 2018-07-10

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800455
Hyphenated Format 36800-455

Supplemental Identifiers

RxCUI
1148399
UNII
362O9ITL9D

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 8 hr arthritis pain relief (source: ndc)
Generic Name acetaminophen (source: ndc)
Application Number ANDA075077 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (36800-455-83) / 225 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
source: ndc

Packages (1)

Ingredients (1)

acetaminophen (650 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "6be40153-a08e-4a37-8416-75167ab0efa6", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["1148399"], "spl_set_id": ["a82f8818-1c22-46d0-b05f-698d2395ac48"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-455-83)  / 225 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "36800-455-83", "marketing_start_date": "20240416"}], "brand_name": "topcare 8 hr arthritis pain relief", "product_id": "36800-455_6be40153-a08e-4a37-8416-75167ab0efa6", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "product_ndc": "36800-455", "generic_name": "Acetaminophen", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare 8 hr arthritis pain relief", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}], "application_number": "ANDA075077", "marketing_category": "ANDA", "marketing_start_date": "20180710", "listing_expiration_date": "20261231"}