Acetylcysteine NDC 63323-693

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-693Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0693Add 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
63323-693-10	63323069310	3 VIAL in 1 CARTON (63323-693-10) / 10 mL in 1 VIAL (63323-693-22)Marketed from Mar 31, 2014

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 — 100 mg/mL
Dosage form: Solution
Route: Oral, Respiratory (Inhalation)
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204674
Marketing start: Mar 31, 2014
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 63323-693_da00a3b4-d7e8-464b-a13f-422b445de8eeSPL ID da00a3b4-d7e8-464b-a13f-422b445de8eeSPL set ID 75b48fab-cef6-465c-a1e0-d085b3988bc4RxCUI 307718, 307719UNII 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.

NDC on a medical claim

N463323069310 followed by a unit qualifier and the quantity

Package 63323-0693-10. 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 Aug 15, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Acetylcysteine Solution, USP 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 bronc…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204674

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

FDA NDC Directory listings under ANDA 204674
Product	Strength	Form · route	Labeler	Product NDC
Acetylcysteine	Acetylcysteine 100 mg/mL	SolutionOral, Respiratory (Inhalation)	Fresenius Kabi USA, LLC	63323-691
Acetylcysteine	Acetylcysteine 100 mg/mL	SolutionOral, Respiratory (Inhalation)	Fresenius Kabi USA, LLC	63323-695