Acetylcysteine NDC 0517-7604

NDC codes

FDA NDC Directory

Product NDC (as listed)0517-7604Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00517-7604Add 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
0517-7604-25	00517760425	25 VIAL, GLASS in 1 TRAY (0517-7604-25) / 4 mL in 1 VIAL, GLASSMarketed from Oct 1, 1995

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: Inhalant
Route: Respiratory (Inhalation)
Labeler: American Regent, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 072547
Marketing start: Oct 1, 1995
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 0517-7604_2bcb9dd3-17f8-439e-a395-aa081c5cc4bfSPL ID 2bcb9dd3-17f8-439e-a395-aa081c5cc4bfSPL set ID f56b4087-db48-4fd7-84ec-9c927962b805RxCUI 307718, 307719UNII WYQ7N0BPYCUPC 0305177510032, 0305177604250, 0305177504253, 0305177610039
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.

NDC on a medical claim

N400517760425 followed by a unit qualifier and the quantity

Package 00517-7604-25. 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 Dec 17, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Acetylcysteine is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretions in such conditions as: Chronic bronchopulmonary disease (chronic emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis and primary amyloidosis of the lung) Acute bronchopulmonary disease (pneumonia, bronchitis, tracheobronchitis) Pulmonary complications of cystic fibrosis Tracheostomy care Pulmonary complications associated with surgery Use during anesthesia Post-traumatic chest conditions Atelectasis due to mucous obstruction Diagnostic bronchial studies (bronchograms, bronchospirometry, and bronchial wedge cath…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 072547

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

FDA NDC Directory listings under ANDA 072547
Product	Strength	Form · route	Labeler	Product NDC
Acetylcysteine	Acetylcysteine 200 mg/mL	InhalantRespiratory (Inhalation)	American Regent, Inc.	0517-7610
Acetylcysteine	Acetylcysteine 200 mg/mL	InhalantRespiratory (Inhalation)	Cardinal Health 107, LLC	55154-5731