What is NDC 63323-694?

63323-694 is the product NDC for Acetylcysteine, Acetylcysteine 200 mg/mL solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Acetylcysteine?

28 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Acetylcysteine NDC 63323-694 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-694Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0694Add 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
63323-694-44	63323069444	25 VIAL in 1 CARTON (63323-694-44) / 4 mL in 1 VIAL (63323-694-41)Marketed from Sep 1, 2012

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: Solution
Route: Oral, Respiratory (Inhalation)
Labeler: Fresenius Kabi USA, LLCNDC labeler code 63323
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203853
Marketing start: Sep 1, 2012
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 63323-694_eeea4928-a68a-4552-836f-d819de9de1d4SPL ID eeea4928-a68a-4552-836f-d819de9de1d4SPL set ID 8d81039e-20ef-5144-e053-2a95a90a89fdRxCUI 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

N463323069444 followed by a unit qualifier and the quantity

Package 63323-0694-44. 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 Oct 31, 2022.

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)

About NDC 63323-694

What is NDC 63323-694?: 63323-694 is the product NDC for Acetylcysteine, Acetylcysteine 200 mg/mL solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Acetylcysteine.
What is the active ingredient?: Acetylcysteine.
Who is the labeler?: Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Acetylcysteine?: 28 other product NDCs are listed under this name. See all Acetylcysteine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Acetylcysteine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Acetylcysteine	Acetylcysteine 200 mg/mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9433	00143-9433-04
Acetylcysteine	Acetylcysteine 100 mg/mL	SolutionRespiratory (Inhalation)	Cameron Pharmaceuticals	42494-435	42494-0435-25
Acetylcysteine	Acetylcysteine 200 mg/mL	SolutionRespiratory (Inhalation)	Cameron Pharmaceuticals	42494-436	42494-0436-25
Acetylcysteine	Acetylcysteine 100 mg/mL	SolutionRespiratory (Inhalation)	Somerset Therapeutics, LLC	70069-018	70069-0018-25
Acetylcysteine	Acetylcysteine 200 mg/mL	SolutionRespiratory (Inhalation)	Somerset Therapeutics, LLC	70069-019	70069-0019-25
Acetylcysteine	Acetylcysteine 200 mg/mL	SolutionRespiratory (Inhalation)	Somerset Therapeutics, LLC	70069-020	70069-0020-03
Acetylcysteine	Acetylcysteine 200 mg/mL	Injection, SolutionIntravenous	Glenmark Pharmaceuticals Inc., USA	68462-946	68462-0946-12
Acetylcysteine	Acetylcysteine 200 mg/mL	Injection, SolutionIntravenous	Somerset Therapeutics, LLC	70069-788	70069-0788-04
Acetylcysteine	Acetylcysteine 200 mg/mL	Injection, SolutionIntravenous	Xellia Pharmaceuticals USA LLC	70594-111	70594-0111-02
Acetylcysteine	Acetylcysteine 200 mg/mL	Injection, SolutionIntravenous	ONESOURCE SPECIALTY PHARMA LIMITED	83270-001	83270-0001-04

All 29 Acetylcysteine NDCs

Other NDCs under ANDA 203853

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

FDA NDC Directory listings under ANDA 203853
Product	Strength	Form · route	Labeler	Product NDC
Acetylcysteine	Acetylcysteine 200 mg/mL	SolutionOral, Respiratory (Inhalation)	Fresenius Kabi USA, LLC	63323-690
Acetylcysteine	Acetylcysteine 200 mg/mL	SolutionOral, Respiratory (Inhalation)	Fresenius Kabi USA, LLC	63323-692