Prescription drug · NDA
Emsam (Selegiline) NDC 49502-901
Selegiline 9 mg/24h · Patch · Transdermal · Viatris Specialty LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49502-901-30 | 49502090130 | 30 POUCH in 1 CARTON (49502-901-30) / 1 PATCH in 1 POUCH (49502-901-01) / 24 h in 1 PATCHMarketed from Feb 27, 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)
- Emsam
- Generic name (nonproprietary)
- selegiline
- Active ingredients
- Selegiline — 9 mg/24h
- Dosage form
- Patch
- Route
- Transdermal
- Labeler
- Viatris Specialty LLCNDC labeler code 49502
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021336
- Marketing start
- Listing expires
- Other FDA classes
- Monoamine Oxidase Inhibitors (Mechanism)Monoamine Oxidase-B Inhibitors (Mechanism)
- Identifiers
- Product ID 49502-901_97cc8813-9de7-42f5-89dd-c46f8b6730faSPL ID 97cc8813-9de7-42f5-89dd-c46f8b6730faSPL set ID b891bd9f-fdb8-4862-89c5-ecdd700398a3RxCUI 865206, 865208, 865210, 865212, 865214, 865216UNII 2K1V7GP655
- Pharmacologic class
- Monoamine Oxidase Inhibitor; Monoamine Oxidase Type B 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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N449502090130followed by a unit qualifier and the quantityPackage 49502-0901-30. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
EMSAM (selegiline transdermal system) is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14) ] . EMSAM ® (selegiline transdermal system) is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of major depressive disorder (MDD) ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 49502-901
- What is NDC 49502-901?
- 49502-901 is the product NDC for Emsam (selegiline), Selegiline 9 mg/24h patch, listed with the FDA by Viatris Specialty LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Emsam (Selegiline).
- What is the active ingredient?
- Selegiline.
- Who is the labeler?
- Viatris Specialty LLC, NDC labeler code 49502. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Emsam?
- 2 other product NDCs are listed under this name. See all Emsam NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Emsam products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Emsamselegiline | Selegiline 6 mg/24h | PatchTransdermal | Viatris Specialty LLC | 49502-900 | 49502-0900-0549502-0900-30 |
| Emsamselegiline | Selegiline 12 mg/24h | PatchTransdermal | Viatris Specialty LLC | 49502-902 | 49502-0902-30 |
Other NDCs under NDA 021336
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 |
|---|---|---|---|---|
| Emsamselegiline | Selegiline 6 mg/24h | PatchTransdermal | Viatris Specialty LLC | 49502-900 |
| Emsamselegiline | Selegiline 12 mg/24h | PatchTransdermal | Viatris Specialty LLC | 49502-902 |