Rasagiline (rasagiline mesylate) NDC 83085-008

NDC codes

FDA NDC Directory

Product NDC (as listed)83085-008Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83085-0008Add 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
83085-008-10	83085000810	1000 TABLET in 1 BOTTLE (83085-008-10)Marketed from Apr 4, 2025
83085-008-30	83085000830	30 TABLET in 1 BOTTLE (83085-008-30)Marketed from Apr 4, 2025
83085-008-50	83085000850	500 TABLET in 1 BOTTLE (83085-008-50)Marketed from Apr 4, 2025

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): Rasagiline
Generic name (nonproprietary): rasagiline mesylate
Active ingredients: Rasagiline mesylate — 1 mg/1
Dosage form: Tablet
Route: Oral
Labeler: SKG Pharma Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218163
Marketing start: Apr 4, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Monoamine Oxidase Inhibitors (Mechanism)
Identifiers: Product ID 83085-008_9ce75c86-75fb-4e5d-a5a6-25696c5593f4SPL ID 9ce75c86-75fb-4e5d-a5a6-25696c5593f4SPL set ID 5c234b28-29e7-4149-9505-e2818a692bcaRxCUI 608328, 636664UNII LH8C2JI290
Pharmacologic class: Monoamine Oxidase Inhibitor

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

N483085000810 followed by a unit qualifier and the quantity

Package 83085-0008-10. 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 Apr 4, 2025.

Indications (excerpt from the label)

Rasagiline tablets are indicated for the treatment of Parkinson’s disease (PD). Rasagiline, a monoamine oxidase (MAO)-B inhibitor (MAOI), is indicated for the treatment of Parkinson’s disease (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 218163

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

FDA NDC Directory listings under ANDA 218163
Product	Strength	Form · route	Labeler	Product NDC
Rasagilinerasagiline mesylate	Rasagiline mesylate .5 mg/1	TabletOral	SKG Pharma Inc.	83085-007
Rasagilinerasagiline mesylate	Rasagiline mesylate .5 mg/1	TabletOral	Rising Pharma Holdings, Inc.	64980-711
Rasagilinerasagiline mesylate	Rasagiline mesylate 1 mg/1	TabletOral	Rising Pharma Holdings, Inc.	64980-712