acetylcysteine

Generic: acetylcysteine

Labeler: padagis us llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name acetylcysteine
Generic Name acetylcysteine
Labeler padagis us llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

acetylcysteine 200 mg/mL

Manufacturer
Padagis US LLC

Identifiers & Regulatory

Product NDC 0574-0805
Product ID 0574-0805_b123834f-a908-4e77-bf87-32dffefa20f1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021539
Listing Expiration 2027-12-31
Marketing Start 2012-12-20

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 05740805
Hyphenated Format 0574-0805

Supplemental Identifiers

RxCUI
465377
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 acetylcysteine (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 (0574-0805-30) / 30 mL in 1 VIAL
source: ndc

Packages (1)

0574-0805-30 4 VIAL in 1 CARTON (0574-0805-30) / 30 mL in 1 VIAL

Ingredients (1)

acetylcysteine (200 mg/mL)

Linked Drug Pages (1)

acetylcysteine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b123834f-a908-4e77-bf87-32dffefa20f1", "openfda": {"nui": ["N0000175429", "N0000175961", "N0000008867", "N0000175960", "N0000175776", "N0000175547"], "unii": ["WYQ7N0BPYC"], "rxcui": ["465377"], "spl_set_id": ["9d305722-e74f-4f48-8d2c-0daa99144749"], "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": ["Padagis US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 VIAL in 1 CARTON (0574-0805-30)  / 30 mL in 1 VIAL", "package_ndc": "0574-0805-30", "marketing_start_date": "20121220"}], "brand_name": "acetylcysteine", "product_id": "0574-0805_b123834f-a908-4e77-bf87-32dffefa20f1", "dosage_form": "INJECTION", "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": "0574-0805", "generic_name": "Acetylcysteine", "labeler_name": "Padagis US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "acetylcysteine", "active_ingredients": [{"name": "ACETYLCYSTEINE", "strength": "200 mg/mL"}], "application_number": "NDA021539", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20121220", "listing_expiration_date": "20271231"}