NDC codes

FDA NDC Directory
Product NDC (as listed)0187-0453Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00187-0453Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0187-0453-02001870453026 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

N400187045302 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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