topcare 8 hour pain relief

Generic: acetaminophen

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

Drug Facts

Product Profile

Brand Name topcare 8 hour 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 36800-369
Product ID 36800-369_c2db19bf-4ebf-4cd8-a6fd-892b50938f17
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075077
Listing Expiration 2026-12-31
Marketing Start 2017-04-05

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800369
Hyphenated Format 36800-369

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 hour 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 (36800-369-78) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
source: ndc

Packages (1)

36800-369-78 1 BOTTLE in 1 CARTON (36800-369-78) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Ingredients (1)

acetaminophen (650 mg/1)

Linked Drug Pages (1)

Topcare 8 Hour Pain Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c2db19bf-4ebf-4cd8-a6fd-892b50938f17", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["1148399"], "spl_set_id": ["38abe710-3d8a-41b0-b057-38c5dfd53322"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-369-78)  / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "36800-369-78", "marketing_start_date": "20170405"}], "brand_name": "Topcare 8 Hour Pain Relief", "product_id": "36800-369_c2db19bf-4ebf-4cd8-a6fd-892b50938f17", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "product_ndc": "36800-369", "generic_name": "Acetaminophen", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare 8 Hour Pain Relief", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}], "application_number": "ANDA075077", "marketing_category": "ANDA", "marketing_start_date": "20170405", "listing_expiration_date": "20261231"}