acetaminophen

Generic: acetaminophen

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen
Generic Name acetaminophen
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

acetaminophen 10 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-434
Product ID 63323-434_be958bb9-95c1-4525-a145-f1372f08f978
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204767
Listing Expiration 2026-12-31
Marketing Start 2020-12-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323434
Hyphenated Format 63323-434

Supplemental Identifiers

RxCUI
483017
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 NDA204767 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 20 BAG in 1 CASE (63323-434-00) / 100 mL in 1 BAG (63323-434-41)
source: ndc

Packages (1)

63323-434-00 20 BAG in 1 CASE (63323-434-00) / 100 mL in 1 BAG (63323-434-41)

Ingredients (1)

acetaminophen (10 mg/mL)

Linked Drug Pages (1)

Acetaminophen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "be958bb9-95c1-4525-a145-f1372f08f978", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["483017"], "spl_set_id": ["a0cece43-256e-4adc-92f8-11a0f473bb83"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 BAG in 1 CASE (63323-434-00)  / 100 mL in 1 BAG (63323-434-41)", "package_ndc": "63323-434-00", "marketing_start_date": "20201206"}], "brand_name": "Acetaminophen", "product_id": "63323-434_be958bb9-95c1-4525-a145-f1372f08f978", "dosage_form": "INJECTION", "product_ndc": "63323-434", "generic_name": "ACETAMINOPHEN", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "10 mg/mL"}], "application_number": "NDA204767", "marketing_category": "NDA", "marketing_start_date": "20201206", "listing_expiration_date": "20261231"}