Prescription drug · ANDA
Rasagiline NDC 84386-170
Rasagiline mesylate 1 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84386-170-30 | 8438601703084386017030 | 30 TABLET in 1 BOTTLE (84386-170-30)Marketed from Oct 20, 2026 |
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
- Active ingredients
- Rasagiline mesylate — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 84386
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201971
- Marketing start
- Listing expires
- Other FDA classes
- Monoamine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 84386-170_68cef20f-10c0-475e-af95-b7799355c7e9SPL ID 68cef20f-10c0-475e-af95-b7799355c7e9SPL set ID 68cef20f-10c0-475e-af95-b7799355c7e9RxCUI 608328, 636664UNII LH8C2JI290UPC 0384386170305
- 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
N484386017030followed by a unit qualifier and the quantityPackage 84386-0170-30. 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 tablets, a monoamine oxidase (MAO)-B inhibitor (MAOI), are indicated for the treatment of Parkinson’s disease ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 84386-170
- What is NDC 84386-170?
- 84386-170 is the product NDC for Rasagiline, Rasagiline mesylate 1 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rasagiline.
- What is the active ingredient?
- Rasagiline mesylate.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 84386. 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 |
| Rasagilinerasagiline mesylate | Rasagiline mesylate 1 mg/1 | TabletOral | SKG Pharma Inc. | 83085-008 | 83085-0008-1083085-0008-3083085-0008-50 |
Other NDCs under ANDA 201971
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 |
|---|---|---|---|---|
| Rasagiline | Rasagiline mesylate .5 mg/1 | TabletOral | Aurobindo Pharma Limited | 84386-169 |