acetaminophen

Generic: acetaminophen

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen
Generic Name acetaminophen
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

acetaminophen 10 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-647
Product ID 68083-647_04cdb516-3f83-45c4-a608-6a08b1fb6cf0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219215
Listing Expiration 2026-12-31
Marketing Start 2025-04-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083647
Hyphenated Format 68083-647

Supplemental Identifiers

RxCUI
483017 2480095
UPC
0368083647018 0368083648015
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 ANDA219215 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 24 BAG in 1 CARTON (68083-647-01) / 50 mL in 1 BAG
source: ndc

Packages (1)

68083-647-01 24 BAG in 1 CARTON (68083-647-01) / 50 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": "04cdb516-3f83-45c4-a608-6a08b1fb6cf0", "openfda": {"upc": ["0368083647018", "0368083648015"], "unii": ["362O9ITL9D"], "rxcui": ["483017", "2480095"], "spl_set_id": ["db5d4cf8-762a-4111-971e-91c704bc3643"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BAG in 1 CARTON (68083-647-01)  / 50 mL in 1 BAG", "package_ndc": "68083-647-01", "marketing_start_date": "20250402"}], "brand_name": "Acetaminophen", "product_id": "68083-647_04cdb516-3f83-45c4-a608-6a08b1fb6cf0", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "68083-647", "generic_name": "Acetaminophen", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "10 mg/mL"}], "application_number": "ANDA219215", "marketing_category": "ANDA", "marketing_start_date": "20250402", "listing_expiration_date": "20261231"}