acetylcysteine

Generic: acetylcysteine

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetylcysteine
Generic Name acetylcysteine
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

acetylcysteine 6 g/30mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-259
Product ID 55150-259_74f2798c-0d88-4888-ad41-23e3d7111748
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207358
Listing Expiration 2026-12-31
Marketing Start 2016-02-29

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 55150259
Hyphenated Format 55150-259

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 ANDA207358 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 6 g/30mL
source: ndc
Packaging
  • 4 VIAL, SINGLE-DOSE in 1 CARTON (55150-259-30) / 30 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-259-30 4 VIAL, SINGLE-DOSE in 1 CARTON (55150-259-30) / 30 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

acetylcysteine (6 g/30mL)

Linked Drug Pages (1)

Acetylcysteine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "74f2798c-0d88-4888-ad41-23e3d7111748", "openfda": {"nui": ["N0000175429", "N0000175961", "N0000008867", "N0000175960", "N0000175776", "N0000175547"], "unii": ["WYQ7N0BPYC"], "rxcui": ["465377"], "spl_set_id": ["5ae53725-1abb-4122-9c85-f26c2c31566c"], "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": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 VIAL, SINGLE-DOSE in 1 CARTON (55150-259-30)  / 30 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-259-30", "marketing_start_date": "20160229"}], "brand_name": "Acetylcysteine", "product_id": "55150-259_74f2798c-0d88-4888-ad41-23e3d7111748", "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": "55150-259", "generic_name": "Acetylcysteine", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetylcysteine", "active_ingredients": [{"name": "ACETYLCYSTEINE", "strength": "6 g/30mL"}], "application_number": "ANDA207358", "marketing_category": "ANDA", "marketing_start_date": "20160229", "listing_expiration_date": "20261231"}