Prescription drug · NDA
Azilect (Rasagiline mesylate) NDC 68546-229
Rasagiline mesylate 1 mg/1 · Tablet · Oral · Teva Neuroscience, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68546-229-56 | 6854602295668546022956 | 30 TABLET in 1 BOTTLE (68546-229-56)Marketed from Jul 10, 2006 |
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)
- Azilect
- Generic name (nonproprietary)
- rasagiline mesylate
- Active ingredients
- Rasagiline mesylate — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Teva Neuroscience, Inc.NDC labeler code 68546
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021641
- Marketing start
- Listing expires
- Other FDA classes
- Monoamine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 68546-229_485881b0-fd51-4bea-8235-43efb940cd64SPL ID 485881b0-fd51-4bea-8235-43efb940cd64SPL set ID a40d0e73-3f9f-4b01-979d-402c9cdaeb60RxCUI 608328, 636664, 637185, 637218UNII 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
N468546022956followed by a unit qualifier and the quantityPackage 68546-0229-56. 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)
AZILECT (rasagiline tablets) is indicated for the treatment of Parkinson’s disease (PD). AZILECT, 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 68546-229
- What is NDC 68546-229?
- 68546-229 is the product NDC for Azilect (rasagiline mesylate), Rasagiline mesylate 1 mg/1 tablet, listed with the FDA by Teva Neuroscience, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Azilect (Rasagiline mesylate).
- What is the active ingredient?
- Rasagiline mesylate.
- Who is the labeler?
- Teva Neuroscience, Inc., NDC labeler code 68546. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Azilect?
- 1 other product NDC are listed under this name. See all Azilect NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Azilect products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Azilectrasagiline mesylate | Rasagiline mesylate .5 mg/1 | TabletOral | Teva Neuroscience, Inc. | 68546-142 | 68546-0142-56 |
Other NDCs under NDA 021641
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 |
|---|---|---|---|---|
| Azilectrasagiline mesylate | Rasagiline mesylate .5 mg/1 | TabletOral | Teva Neuroscience, Inc. | 68546-142 |
| Rasagiline | Rasagiline mesylate .5 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-3060 |
| Rasagiline | Rasagiline mesylate 1 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-3061 |