acetaminophen

Generic: acetaminophen

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen
Generic Name acetaminophen
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8425
Product ID 0615-8425_7774b1f8-0e7d-4570-b836-c33c0bbd4834
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA215486
Marketing Start 2021-10-04
Marketing End 2026-04-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06158425
Hyphenated Format 0615-8425

Supplemental Identifiers

RxCUI
1148399
UNII
362O9ITL9D

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 ANDA215486 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8425-39)
source: ndc

Packages (1)

0615-8425-39 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8425-39)

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": "7774b1f8-0e7d-4570-b836-c33c0bbd4834", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["1148399"], "spl_set_id": ["d580b9c5-1999-4156-9bda-9bf87302fa62"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8425-39)", "package_ndc": "0615-8425-39", "marketing_end_date": "20260430", "marketing_start_date": "20220210"}], "brand_name": "Acetaminophen", "product_id": "0615-8425_7774b1f8-0e7d-4570-b836-c33c0bbd4834", "dosage_form": "TABLET, EXTENDED RELEASE", "product_ndc": "0615-8425", "generic_name": "Acetaminophen", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}], "application_number": "ANDA215486", "marketing_category": "ANDA", "marketing_end_date": "20260430", "marketing_start_date": "20211004"}