Prescription drug · ANDA
Rasagiline NDC 62135-676
Rasagiline mesylate .5 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-676-30 | 62135067630 | 30 TABLET in 1 BOTTLE (62135-676-30)Marketed from May 1, 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 — .5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201892
- Marketing start
- Listing expires
- Other FDA classes
- Monoamine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 62135-676_17dd92b2-969b-16f1-e063-6394a90aee89SPL ID 17dd92b2-969b-16f1-e063-6394a90aee89SPL set ID d9168d62-814a-444f-9d70-11674def339dRxCUI 608328, 636664UNII LH8C2JI290UPC 0362135677305, 0362135676308
- 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
N462135067630followed by a unit qualifier and the quantityPackage 62135-0676-30. 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.
Other NDCs under ANDA 201892
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 1 mg/1 | TabletOral | Chartwell RX, LLC | 62135-677 |