acetylcysteine

Generic: acetylcysteine

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetylcysteine
Generic Name acetylcysteine
Labeler fresenius kabi usa, llc
Dosage Form SOLUTION
Routes
ORAL RESPIRATORY (INHALATION)
Active Ingredients

acetylcysteine 100 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-695
Product ID 63323-695_da00a3b4-d7e8-464b-a13f-422b445de8ee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204674
Listing Expiration 2026-12-31
Marketing Start 2014-03-31

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 63323695
Hyphenated Format 63323-695

Supplemental Identifiers

RxCUI
307718 307719
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 ANDA204674 (source: ndc)
Routes
ORAL RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (63323-695-04) / 4 mL in 1 VIAL (63323-695-22)
source: ndc

Packages (1)

63323-695-04 25 VIAL in 1 CARTON (63323-695-04) / 4 mL in 1 VIAL (63323-695-22)

Ingredients (1)

acetylcysteine (100 mg/mL)

Linked Drug Pages (1)

Acetylcysteine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL", "RESPIRATORY (INHALATION)"], "spl_id": "da00a3b4-d7e8-464b-a13f-422b445de8ee", "openfda": {"nui": ["N0000175429", "N0000175961", "N0000008867", "N0000175960", "N0000175776", "N0000175547"], "unii": ["WYQ7N0BPYC"], "rxcui": ["307718", "307719"], "spl_set_id": ["75b48fab-cef6-465c-a1e0-d085b3988bc4"], "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": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (63323-695-04)  / 4 mL in 1 VIAL (63323-695-22)", "package_ndc": "63323-695-04", "marketing_start_date": "20140331"}], "brand_name": "Acetylcysteine", "product_id": "63323-695_da00a3b4-d7e8-464b-a13f-422b445de8ee", "dosage_form": "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": "63323-695", "generic_name": "ACETYLCYSTEINE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetylcysteine", "active_ingredients": [{"name": "ACETYLCYSTEINE", "strength": "100 mg/mL"}], "application_number": "ANDA204674", "marketing_category": "ANDA", "marketing_start_date": "20140331", "listing_expiration_date": "20261231"}