Prescription drug · ANDA
Rasagiline NDC 16714-770
Rasagiline mesylate .5 mg/1 · Tablet · Oral · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-770-01 | 1671407700116714077001 | 30 TABLET in 1 BOTTLE (16714-770-01)Marketed from Apr 17, 2018 |
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
- NorthStar RxLLCNDC labeler code 16714
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201889
- Marketing start
- Listing expires
- Other FDA classes
- Monoamine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 16714-770_dfffedf4-c1f0-4bbd-9978-80dcec656d72SPL ID dfffedf4-c1f0-4bbd-9978-80dcec656d72SPL set ID 8bf8e76c-27cb-42a4-aa9c-bdade68c463bRxCUI 608328, 636664UNII LH8C2JI290UPC 0316714771014, 0316714770017
- 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
N416714077001followed by a unit qualifier and the quantityPackage 16714-0770-01. 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 ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 16714-770
- What is NDC 16714-770?
- 16714-770 is the product NDC for Rasagiline, Rasagiline mesylate .5 mg/1 tablet, listed with the FDA by NorthStar RxLLC. 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?
- NorthStar RxLLC, NDC labeler code 16714. 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 201889
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 | NorthStar RxLLC | 16714-771 |
| Rasagiline | Rasagiline mesylate .5 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-259 |
| Rasagiline | Rasagiline mesylate 1 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-260 |
| Rasagiline | Rasagiline mesylate .5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4683 |
| Rasagiline | Rasagiline mesylate 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4735 |