acetaminophen

Generic: acetaminophen

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen
Generic Name acetaminophen
Labeler caplin steriles limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

acetaminophen 10 mg/mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-157
Product ID 65145-157_b6f83919-8608-4648-9ac6-e13eadac8404
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219096
Listing Expiration 2026-12-31
Marketing Start 2025-12-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65145157
Hyphenated Format 65145-157

Supplemental Identifiers

RxCUI
483017
UPC
0365145157010
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 ANDA219096 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 POUCH in 1 CASE (65145-157-10) / 1 BAG in 1 POUCH (65145-157-01) / 100 mL in 1 BAG
source: ndc

Packages (1)

65145-157-10 10 POUCH in 1 CASE (65145-157-10) / 1 BAG in 1 POUCH (65145-157-01) / 100 mL in 1 BAG

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": "b6f83919-8608-4648-9ac6-e13eadac8404", "openfda": {"upc": ["0365145157010"], "unii": ["362O9ITL9D"], "rxcui": ["483017"], "spl_set_id": ["b6f83919-8608-4648-9ac6-e13eadac8404"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CASE (65145-157-10)  / 1 BAG in 1 POUCH (65145-157-01)  / 100 mL in 1 BAG", "package_ndc": "65145-157-10", "marketing_start_date": "20251218"}], "brand_name": "Acetaminophen", "product_id": "65145-157_b6f83919-8608-4648-9ac6-e13eadac8404", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "65145-157", "generic_name": "Acetaminophen", "labeler_name": "Caplin Steriles Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "10 mg/mL"}], "application_number": "ANDA219096", "marketing_category": "ANDA", "marketing_start_date": "20251218", "listing_expiration_date": "20261231"}