Prescription drug · ANDA
Rasagiline NDC 33342-309
Rasagiline mesylate 1 mg/1 · Tablet · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-309-07 | 33342030907 | 30 TABLET in 1 BOTTLE (33342-309-07)Marketed from Jun 29, 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)
- Rasagiline
- Generic name (nonproprietary)
- rasagiline
- Active ingredients
- Rasagiline mesylate — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Macleods Pharmaceuticals LimitedNDC labeler code 33342
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208866
- Marketing start
- Listing expires
- Other FDA classes
- Monoamine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 33342-309_1650fc1f-ed87-411c-af06-97b9ff242da7SPL ID 1650fc1f-ed87-411c-af06-97b9ff242da7SPL set ID e8771c7e-5ecf-47dc-a0fd-4d12e85631a6RxCUI 608328, 636664UNII LH8C2JI290UPC 0333342309075, 0333342308078
- 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
N433342030907followed by a unit qualifier and the quantityPackage 33342-0309-07. 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), is indicated for the treatment of Parkinson's disease
Excerpt only. Read the full label for complete information.
About NDC 33342-309
- What is NDC 33342-309?
- 33342-309 is the product NDC for Rasagiline, Rasagiline mesylate 1 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals 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?
- Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 208866
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 | Macleods Pharmaceuticals Limited | 33342-308 |