What is NDC 83853-101?

83853-101 is the product NDC for Aqneursa (levacetylleucine), Levacetylleucine 1000 mg/1 granule, for suspension, listed with the FDA by IntraBio Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

IntraBio Inc, NDC labeler code 83853. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Aqneursa?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Aqneursa NDC 83853-101 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)83853-101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83853-0101Add 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
83853-101-01	83853010101	28 PACKET in 1 CARTON (83853-101-01) / 1 GRANULE, FOR SUSPENSION in 1 PACKETMarketed from Sep 24, 2024

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): Aqneursa
Generic name (nonproprietary): levacetylleucine
Active ingredients: Levacetylleucine — 1000 mg/1
Dosage form: Granule, For suspension
Route: Oral
Labeler: IntraBio IncNDC labeler code 83853
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 219132
Marketing start: Sep 24, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Bile Salt Export Pump Inhibitors (Mechanism)Breast Cancer Resistance Protein Inhibitors (Mechanism)Organic Anion Transporter 1 Inhibitors (Mechanism)Organic Anion Transporter 3 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 83853-101_c94eb0a9-2978-4fa6-9bc2-e02f7da94768SPL ID c94eb0a9-2978-4fa6-9bc2-e02f7da94768

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N483853010101 followed by a unit qualifier and the quantity

Package 83853-0101-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 83853-101

What is NDC 83853-101?: 83853-101 is the product NDC for Aqneursa (levacetylleucine), Levacetylleucine 1000 mg/1 granule, for suspension, listed with the FDA by IntraBio Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Aqneursa (Levacetylleucine).
What is the active ingredient?: Levacetylleucine.
Who is the labeler?: IntraBio Inc, NDC labeler code 83853. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Aqneursa?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Aqneursa (Levacetylleucine) NDC 83853-101