acetaminophen

Generic: acetaminophen tablet extended release

Labeler: asclemed usa, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen
Generic Name acetaminophen tablet extended release
Labeler asclemed usa, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-914
Product ID 76420-914_2ef14964-4fa1-9fb6-e063-6294a90aff36
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA215486
Listing Expiration 2026-12-31
Marketing Start 2021-10-04

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420914
Hyphenated Format 76420-914

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 tablet extended release (source: ndc)
Application Number ANDA215486 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-01)
  • 50 BOTTLE in 1 CARTON (76420-914-05) / 1 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 225 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-26)
  • 400 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-40)
  • 1 BOTTLE in 1 CARTON (76420-914-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-60)
source: ndc

Packages (6)

76420-914-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-01) 76420-914-05 50 BOTTLE in 1 CARTON (76420-914-05) / 1 TABLET, EXTENDED RELEASE in 1 BOTTLE 76420-914-26 225 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-26) 76420-914-40 400 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-40) 76420-914-42 1 BOTTLE in 1 CARTON (76420-914-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE 76420-914-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-60)

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": "2ef14964-4fa1-9fb6-e063-6294a90aff36", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["1148399"], "spl_set_id": ["4ef6bc2b-03cf-474f-bb9e-dbb5792ec197"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-01)", "package_ndc": "76420-914-01", "marketing_start_date": "20250127"}, {"sample": false, "description": "50 BOTTLE in 1 CARTON (76420-914-05)  / 1 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "76420-914-05", "marketing_start_date": "20250127"}, {"sample": false, "description": "225 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-26)", "package_ndc": "76420-914-26", "marketing_start_date": "20250125"}, {"sample": false, "description": "400 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-40)", "package_ndc": "76420-914-40", "marketing_start_date": "20250127"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (76420-914-42)  / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "76420-914-42", "marketing_start_date": "20250127"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-60)", "package_ndc": "76420-914-60", "marketing_start_date": "20250225"}], "brand_name": "Acetaminophen", "product_id": "76420-914_2ef14964-4fa1-9fb6-e063-6294a90aff36", "dosage_form": "TABLET, EXTENDED RELEASE", "product_ndc": "76420-914", "generic_name": "Acetaminophen tablet extended release", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}], "application_number": "ANDA215486", "marketing_category": "ANDA", "marketing_start_date": "20211004", "listing_expiration_date": "20261231"}