Acetylcysteine NDC 70594-111

NDC codes

FDA NDC Directory

Product NDC (as listed)70594-111Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70594-0111Add 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
70594-111-02	70594011102	4 VIAL in 1 CARTON (70594-111-02) / 30 mL in 1 VIAL (70594-111-01)Marketed from Jun 10, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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, Solution
Route: Intravenous
Labeler: Xellia Pharmaceuticals USA LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217182
Marketing start: Jun 10, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Glutathione Concentration (Physiologic effect)Reduction Activity (Mechanism)
Identifiers: Product ID 70594-111_bfb03f99-1389-424a-a457-efbb23f198eeSPL ID bfb03f99-1389-424a-a457-efbb23f198eeSPL set ID 3e2e187e-2445-43b1-b66c-b828e2adf022RxCUI 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

N470594011102 followed by a unit qualifier and the quantity

Package 70594-0111-02. 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 May 31, 2023.

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 patients 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 patients with an 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 ANDA 217182

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

FDA NDC Directory listings under ANDA 217182
Product	Strength	Form · route	Labeler	Product NDC
Acetylcysteine	Acetylcysteine 200 mg/mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9433
Acetylcysteine	Acetylcysteine 200 mg/mL	Injection, SolutionIntravenous	ONESOURCE SPECIALTY PHARMA LIMITED	83270-001