Prescription drug · ANDA
Rasagiline (Rasagiline mesylate) NDC 83085-008
Rasagiline mesylate 1 mg/1 · Tablet · Oral · SKG Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83085-008-10 | 8308500081083085000810 | 1000 TABLET in 1 BOTTLE (83085-008-10)Marketed from Apr 4, 2025 | |
| 83085-008-30 | 8308500083083085000830 | 30 TABLET in 1 BOTTLE (83085-008-30)Marketed from Apr 4, 2025 | |
| 83085-008-50 | 8308500085083085000850 | 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.NDC labeler code 83085
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218163
- Marketing start
- Listing expires
- 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
N483085000810followed by a unit qualifier and the quantityPackage 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 .
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.
About NDC 83085-008
- What is NDC 83085-008?
- 83085-008 is the product NDC for Rasagiline (rasagiline mesylate), Rasagiline mesylate 1 mg/1 tablet, listed with the FDA by SKG Pharma Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rasagiline (Rasagiline mesylate).
- What is the active ingredient?
- Rasagiline mesylate.
- Who is the labeler?
- SKG Pharma Inc., NDC labeler code 83085. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rasagiline?
- 26 other product NDCs are listed under this name. See all Rasagiline NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rasagiline products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rasagiline | Rasagiline mesylate 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4735 | 70518-4735-0070518-4735-01 |
| Rasagiline | Rasagiline mesylate .5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4683 | 70518-4683-00 |
| Rasagilinerasagiline mesylate | Rasagiline mesylate .5 mg/1 | TabletOral | Carnegie Pharmaceuticals LLC | 80005-141 | 80005-0141-0880005-0141-1080005-0141-14 |
| Rasagilinerasagiline mesylate | Rasagiline mesylate 1 mg/1 | TabletOral | Carnegie Pharmaceuticals LLC | 80005-142 | 80005-0142-0880005-0142-1080005-0142-14 |
| Rasagiline | Rasagiline mesylate 1 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-446 | 13668-0446-0513668-0446-3013668-0446-90 |
| Rasagiline | Rasagiline mesylate .5 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-447 | 13668-0447-0513668-0447-3013668-0447-90 |
| Rasagilinerasagiline mesylate | Rasagiline mesylate .5 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-711 | 64980-0711-30 |
| Rasagilinerasagiline mesylate | Rasagiline mesylate 1 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-712 | 64980-0712-30 |
| Rasagilinerasagiline mesylate | Rasagiline mesylate .5 mg/1 | TabletOral | SKG Pharma Inc. | 83085-007 | 83085-0007-1083085-0007-3083085-0007-50 |
| Rasagiline | Rasagiline mesylate .5 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-308 | 33342-0308-07 |
Other NDCs under ANDA 218163
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| 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 |
| Rasagilinerasagiline mesylate | Rasagiline mesylate .5 mg/1 | TabletOral | SKG Pharma Inc. | 83085-007 |