acetaminophen

Generic: acetaminophen

Labeler: granules india limited
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen
Generic Name acetaminophen
Labeler granules india limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1

Manufacturer
Granules India Limited

Identifiers & Regulatory

Product NDC 62207-188
Product ID 62207-188_3b99409a-218c-06ee-e063-6394a90aace0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211544
Listing Expiration 2026-12-31
Marketing Start 2019-04-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62207188
Hyphenated Format 62207-188

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 acetaminophen (source: ndc)
Generic Name acetaminophen (source: ndc)
Application Number ANDA211544 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
source: ndc
Packaging
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-188-49)
  • 1 BOTTLE in 1 CARTON (62207-188-51) / 10 TABLET, EXTENDED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

62207-188-49 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-188-49) 62207-188-51 1 BOTTLE in 1 CARTON (62207-188-51) / 10 TABLET, EXTENDED RELEASE in 1 BOTTLE

Ingredients (1)

acetaminophen (650 mg/1)

Linked Drug Pages (1)

ACETAMINOPHEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3b99409a-218c-06ee-e063-6394a90aace0", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["1148399"], "spl_set_id": ["00eb3e4b-1507-4c9a-83a5-ef50cb312753"], "manufacturer_name": ["Granules India Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-188-49)", "package_ndc": "62207-188-49", "marketing_start_date": "20190418"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (62207-188-51)  / 10 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "62207-188-51", "marketing_start_date": "20190418"}], "brand_name": "ACETAMINOPHEN", "product_id": "62207-188_3b99409a-218c-06ee-e063-6394a90aace0", "dosage_form": "TABLET, EXTENDED RELEASE", "product_ndc": "62207-188", "generic_name": "ACETAMINOPHEN", "labeler_name": "Granules India Limited", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ACETAMINOPHEN", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}], "application_number": "ANDA211544", "marketing_category": "ANDA", "marketing_start_date": "20190418", "listing_expiration_date": "20261231"}