Prescription drug · NDA
Zelapar (Selegiline hydrochloride) NDC 0187-0453
Selegiline hydrochloride 1.25 mg/1 · Tablet, Orally disintegrating · Oral · Bausch Health US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0187-0453-02 | 00187045302 | 6 POUCH in 1 CARTON (0187-0453-02) / 10 TABLET, ORALLY DISINTEGRATING in 1 POUCHMarketed from Jun 14, 2006 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Zelapar
- Generic name (nonproprietary)
- selegiline hydrochloride
- Active ingredients
- Selegiline hydrochloride — 1.25 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Bausch Health US, LLCNDC labeler code 0187
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021479
- Marketing start
- Marketing end
- Other FDA classes
- Monoamine Oxidase Inhibitors (Mechanism)Monoamine Oxidase-B Inhibitors (Mechanism)
- Identifiers
- Product ID 0187-0453_ff911cbd-70ba-4034-8831-a81676d7811cSPL ID ff911cbd-70ba-4034-8831-a81676d7811cSPL set ID 380d7717-2a79-42f3-a712-efe5e7696ba0RxCUI 859190, 859192UNII 6W731X367Q
- 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400187045302followed by a unit qualifier and the quantityPackage 00187-0453-02. 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)
ZELAPAR is indicated as an adjunct in the management of patients with Parkinson’s disease being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that ZELAPAR has any beneficial effect in the absence of concurrent levodopa therapy [see Clinical Studies (14 ) ] . ZELAPAR, a monoamine oxidase type B (MAO-B) inhibitor, is indicated as an adjunct in the management of patients with Parkinson’s disease being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0187-0453
- What is NDC 0187-0453?
- 0187-0453 is the product NDC for Zelapar (selegiline hydrochloride), Selegiline hydrochloride 1.25 mg/1 tablet, orally disintegrating, listed with the FDA by Bausch Health US, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zelapar (Selegiline hydrochloride).
- What is the active ingredient?
- Selegiline hydrochloride.
- Who is the labeler?
- Bausch Health US, LLC, NDC labeler code 0187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zelapar?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.