acetaminophen

Generic: acetaminophen

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen
Generic Name acetaminophen
Labeler aurohealth llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-873
Product ID 58602-873_144490f4-f2a5-4c6d-abf2-5e7ee65d66d7
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207229
Listing Expiration 2026-12-31
Marketing Start 2021-12-27

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58602873
Hyphenated Format 58602-873

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 ANDA207229 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (58602-873-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-873-14) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-873-21) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-873-29) / 150 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 200 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-34)
  • 225 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-35)
  • 1 BOTTLE in 1 CARTON (58602-873-36) / 250 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-40)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-41)
  • 400 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-44)
  • 290 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-67)
  • 325 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-76)
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-94)
source: ndc

Packages (13)

58602-873-07 1 BOTTLE in 1 CARTON (58602-873-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE 58602-873-14 1 BOTTLE in 1 CARTON (58602-873-14) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE 58602-873-21 1 BOTTLE in 1 CARTON (58602-873-21) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE 58602-873-29 1 BOTTLE in 1 CARTON (58602-873-29) / 150 TABLET, EXTENDED RELEASE in 1 BOTTLE 58602-873-34 200 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-34) 58602-873-35 225 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-35) 58602-873-36 1 BOTTLE in 1 CARTON (58602-873-36) / 250 TABLET, EXTENDED RELEASE in 1 BOTTLE 58602-873-40 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-40) 58602-873-41 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-41) 58602-873-44 400 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-44) 58602-873-67 290 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-67) 58602-873-76 325 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-76) 58602-873-94 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-94)

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": "144490f4-f2a5-4c6d-abf2-5e7ee65d66d7", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["1148399"], "spl_set_id": ["f076fd33-9eaf-49b9-b0ee-6a349567c5ff"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-873-07)  / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "58602-873-07", "marketing_start_date": "20211227"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-873-14)  / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "58602-873-14", "marketing_start_date": "20211227"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-873-21)  / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "58602-873-21", "marketing_start_date": "20211227"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-873-29)  / 150 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "58602-873-29", "marketing_start_date": "20211227"}, {"sample": false, "description": "200 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-34)", "package_ndc": "58602-873-34", "marketing_start_date": "20211227"}, {"sample": false, "description": "225 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-35)", "package_ndc": "58602-873-35", "marketing_start_date": "20211227"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-873-36)  / 250 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "58602-873-36", "marketing_start_date": "20211227"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-40)", "package_ndc": "58602-873-40", "marketing_start_date": "20211227"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-41)", "package_ndc": "58602-873-41", "marketing_start_date": "20211227"}, {"sample": false, "description": "400 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-44)", "package_ndc": "58602-873-44", "marketing_start_date": "20211227"}, {"sample": false, "description": "290 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-67)", "package_ndc": "58602-873-67", "marketing_start_date": "20211227"}, {"sample": false, "description": "325 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-76)", "package_ndc": "58602-873-76", "marketing_start_date": "20211227"}, {"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-94)", "package_ndc": "58602-873-94", "marketing_start_date": "20211227"}], "brand_name": "Acetaminophen", "product_id": "58602-873_144490f4-f2a5-4c6d-abf2-5e7ee65d66d7", "dosage_form": "TABLET, EXTENDED RELEASE", "product_ndc": "58602-873", "generic_name": "Acetaminophen", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}], "application_number": "ANDA207229", "marketing_category": "ANDA", "marketing_start_date": "20211227", "listing_expiration_date": "20261231"}