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Acetylcysteine

NDC 63323-694 · Fresenius Kabi USA, LLC

FDA carries 2 listing records for this NDC; the most recent is shown.

Generic nameACETYLCYSTEINE
Dosage formSOLUTION
RouteORAL, RESPIRATORY (INHALATION)
Active ingredient(s)ACETYLCYSTEINE
Strength200 mg/mL
Pharmacologic classAntidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]
Marketing categoryANDA

Packages

63323-694-04 — 25 VIAL in 1 CARTON (63323-694-04) / 4 mL in 1 VIAL (63323-694-22)

63323-694-44 — 25 VIAL in 1 CARTON (63323-694-44) / 4 mL in 1 VIAL (63323-694-41)

Billed under HCPCS

J7608 — Acetylcysteine, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose form, per gram Medicare Part B payment limit (ASP + 6%): $6.40

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

42494-435 — Acetylcysteine, 42494-436 — Acetylcysteine, 55150-259 — Acetylcysteine, 55154-5730 — Acetylcysteine, 55154-5731 — Acetylcysteine, 59088-795 — Multivitamin, 63323-690 — ACETYLCYSTEINE, 63323-691 — ACETYLCYSTEINE, 63323-692 — ACETYLCYSTEINE, 63323-693 — ACETYLCYSTEINE, 63323-695 — ACETYLCYSTEINE, 63323-963 — Acetylcysteine, 66220-207 — Acetylcysteine, 68462-946 — Acetylcysteine, 70069-018 — Acetylcysteine, 70069-019 — Acetylcysteine, 70069-020 — Acetylcysteine, 70069-788 — Acetylcysteine, 70594-111 — Acetylcysteine, 83270-001 — Acetylcysteine, +10 more

Poisoning, adverse-effect and underdosing codes for this drug

The ICD-10-CM Table of Drugs and Chemicals carries these diagnosis codes for this drug — a drug-name match derived from FDA's product name and the Table of Drugs and Chemicals, not a CMS-published pairing.

T48.4X1 — Poisoning by expectorants, accidental (unintentional), T48.4X2 — Poisoning by expectorants, intentional self-harm, T48.4X3 — Poisoning by expectorants, assault, T48.4X4 — Poisoning by expectorants, undetermined, T48.4X5 — Adverse effect of expectorants, T48.4X6 — Underdosing of expectorants

From the FDA National Drug Code Directory, retrieved August 24, 2026. Product listings are submitted by labelers; FDA does not verify them.

Read from: FDA National Drug Code Directory, product.txt and package.txt (accessdata.fda.gov/cder/ndctext.zip) — Snapshot retrieved 2026-08-24, loaded 2026-08-24; CMS Medicare Part B Drug Average Sales Price (ASP) Pricing Files (cms.gov/medicare/payment/part-b-drugs/asp-pricing-files) -- the NDC-HCPCS crosswalk and Part B payment limit files — 2026 Q4 (October 2026 release). All data sources · How to read the labels

Current data releases:ICD-10-CM FY2027 · ICD-10-PCS FY2027 · HCPCS October 2026 · MS-DRG v44 · Medicare Code Editor v44.0 · NCCI PTP Q4 2026 · MUE Q4 2026 · NCD code lists 2026-01 · LCD export September 28, 2026 · All releases and sources