acetaminophen

Generic: acetaminophen

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen
Generic Name acetaminophen
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

acetaminophen 1000 mg/100mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9386
Product ID 0143-9386_e5ea1bad-d98b-475c-be6b-1d6415e3edff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA206968
Listing Expiration 2026-12-31
Marketing Start 2022-06-03

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439386
Hyphenated Format 0143-9386

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 NDA206968 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1000 mg/100mL
source: ndc
Packaging
  • 10 BAG in 1 CARTON (0143-9386-10) / 100 mL in 1 BAG (0143-9386-01)
source: ndc

Packages (1)

Ingredients (1)

acetaminophen (1000 mg/100mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "e5ea1bad-d98b-475c-be6b-1d6415e3edff", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["483017"], "spl_set_id": ["88c29438-3648-4b09-bd43-70ad7a35bcb5"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BAG in 1 CARTON (0143-9386-10)  / 100 mL in 1 BAG (0143-9386-01)", "package_ndc": "0143-9386-10", "marketing_start_date": "20220603"}], "brand_name": "Acetaminophen", "product_id": "0143-9386_e5ea1bad-d98b-475c-be6b-1d6415e3edff", "dosage_form": "INJECTION", "product_ndc": "0143-9386", "generic_name": "Acetaminophen", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "1000 mg/100mL"}], "application_number": "NDA206968", "marketing_category": "NDA", "marketing_start_date": "20220603", "listing_expiration_date": "20261231"}