acetadote

Generic: acetylcysteine

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

Drug Facts

Product Profile

Brand Name acetadote
Generic Name acetylcysteine
Labeler cumberland pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

acetylcysteine 200 mg/mL

Manufacturer
Cumberland Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 66220-207
Product ID 66220-207_f8e9f360-c181-40a1-87d6-dcd9a3205000
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021539
Listing Expiration 2026-12-31
Marketing Start 2004-01-23

Pharmacologic Class

Established (EPC)
antidote [epc] antidote for acetaminophen overdose [epc] mucolytic [epc]
Mechanism of Action
reduction activity [moa]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased glutathione concentration [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66220207
Hyphenated Format 66220-207

Supplemental Identifiers

RxCUI
465377 582119
UNII
WYQ7N0BPYC
NUI
N0000175429 N0000175961 N0000008867 N0000175960 N0000175776 N0000175547

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 acetadote (source: ndc)
Generic Name acetylcysteine (source: ndc)
Application Number NDA021539 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 4 VIAL in 1 CARTON (66220-207-30) / 30 mL in 1 VIAL
source: ndc

Packages (1)

66220-207-30 4 VIAL in 1 CARTON (66220-207-30) / 30 mL in 1 VIAL

Ingredients (1)

acetylcysteine (200 mg/mL)

Linked Drug Pages (1)

ACETADOTE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "f8e9f360-c181-40a1-87d6-dcd9a3205000", "openfda": {"nui": ["N0000175429", "N0000175961", "N0000008867", "N0000175960", "N0000175776", "N0000175547"], "unii": ["WYQ7N0BPYC"], "rxcui": ["465377", "582119"], "spl_set_id": ["472f158a-5ab9-4308-8e49-1116e6ea3d39"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Glutathione Concentration [PE]"], "pharm_class_epc": ["Antidote [EPC]", "Antidote for Acetaminophen Overdose [EPC]", "Mucolytic [EPC]"], "pharm_class_moa": ["Reduction Activity [MoA]"], "manufacturer_name": ["Cumberland Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 VIAL in 1 CARTON (66220-207-30)  / 30 mL in 1 VIAL", "package_ndc": "66220-207-30", "marketing_start_date": "20040123"}], "brand_name": "ACETADOTE", "product_id": "66220-207_f8e9f360-c181-40a1-87d6-dcd9a3205000", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antidote [EPC]", "Antidote for Acetaminophen Overdose [EPC]", "Decreased Respiratory Secretion Viscosity [PE]", "Increased Glutathione Concentration [PE]", "Mucolytic [EPC]", "Reduction Activity [MoA]"], "product_ndc": "66220-207", "generic_name": "Acetylcysteine", "labeler_name": "Cumberland Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ACETADOTE", "active_ingredients": [{"name": "ACETYLCYSTEINE", "strength": "200 mg/mL"}], "application_number": "NDA021539", "marketing_category": "NDA", "marketing_start_date": "20040123", "listing_expiration_date": "20261231"}