acetylcysteine NDC 0574-0805

NDC codes

FDA NDC Directory

Product NDC (as listed)0574-0805Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00574-0805Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0574-0805-30	00574080530	4 VIAL in 1 CARTON (0574-0805-30) / 30 mL in 1 VIALMarketed from Dec 20, 2012

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): acetylcysteine
Generic name (nonproprietary): acetylcysteine
Active ingredients: Acetylcysteine — 200 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Padagis US LLC
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 021539
Marketing start: Dec 20, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Glutathione Concentration (Physiologic effect)Reduction Activity (Mechanism)
Identifiers: Product ID 0574-0805_b123834f-a908-4e77-bf87-32dffefa20f1SPL ID b123834f-a908-4e77-bf87-32dffefa20f1SPL set ID 9d305722-e74f-4f48-8d2c-0daa99144749RxCUI 465377UNII WYQ7N0BPYC
Pharmacologic class: Antidote; Antidote for Acetaminophen Overdose; Mucolytic

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400574080530 followed by a unit qualifier and the quantity

Package 00574-0805-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jul 31, 2025.

Indications (excerpt from the label)

Acetylcysteine Injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults and pediatric patients who weigh 5 kg or greater with acute ingestion or from repeated supratherapeutic ingestion (RSI). Acetylcysteine Injection is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults and pediatric patients who weigh 5 kg or greater with acute ingestion or from repeated supratherapeutic ingestion (RSI) ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021539

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021539
Product	Strength	Form · route	Labeler	Product NDC
Acetadoteacetylcysteine	Acetylcysteine 200 mg/mL	Injection, SolutionIntravenous	Cumberland Pharmaceuticals Inc.	66220-207