Selegiline Hydrochloride NDC 72319-006

NDC codes

FDA NDC Directory

Product NDC (as listed)72319-006Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72319-0006Add 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 NDC	11-digit (billing)	Package	Copy
72319-006-02	72319000602	60 TABLET in 1 BOTTLE (72319-006-02)Marketed from Dec 15, 2021

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): Selegiline Hydrochloride
Generic name (nonproprietary): selegiline hydrochloride
Active ingredients: Selegiline hydrochloride — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: i3 Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074672
Marketing start: Dec 15, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Monoamine Oxidase Inhibitors (Mechanism)Monoamine Oxidase-B Inhibitors (Mechanism)
Identifiers: Product ID 72319-006_248576e6-bc11-e847-e063-6294a90afe9dSPL ID 248576e6-bc11-e847-e063-6294a90afe9dSPL set ID c81e983b-455d-2e65-e053-2a95a90a3123RxCUI 859193UNII 6W731X367QUPC 0372319006029
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

N472319000602 followed by a unit qualifier and the quantity

Package 72319-0006-02. 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 Mar 20, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Selegiline Hydrochloride Tablets, USP are indicated as an adjunct in the management of Parkinsonian patients 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 selegiline has any beneficial effect in the absence of concurrent levodopa therapy. Evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa. Selegiline was significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 074672

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 074672
Product	Strength	Form · route	Labeler	Product NDC
Selegiline Hydrochloride	Selegiline hydrochloride 5 mg/1	TabletOral	A2A Integrated Pharmaceuticals	73141-006