Selegiline Hydrochloride NDC 70954-504

NDC codes

FDA NDC Directory

Product NDC (as listed)70954-504Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70954-0504Add 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
70954-504-10	70954050410	60 CAPSULE in 1 BOTTLE (70954-504-10)Marketed from Apr 1, 2021
70954-504-20	70954050420	1000 CAPSULE in 1 BOTTLE (70954-504-20)Marketed from Apr 1, 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: Capsule
Route: Oral
Labeler: Novitium Pharma LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075352
Marketing start: Apr 1, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Monoamine Oxidase Inhibitors (Mechanism)Monoamine Oxidase-B Inhibitors (Mechanism)
Identifiers: Product ID 70954-504_e42d99b0-c62e-49d4-b792-1301bb539b92SPL ID e42d99b0-c62e-49d4-b792-1301bb539b92SPL set ID e42d99b0-c62e-49d4-b792-1301bb539b92RxCUI 859186UNII 6W731X367QUPC 0370954504207, 0370954504108
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

N470954050410 followed by a unit qualifier and the quantity

Package 70954-0504-10. 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 Apr 1, 2021.

Indications (excerpt from the label)

INDICATIONS & USAGE Selegiline hydrochloride capsules, 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 l…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075352

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

FDA NDC Directory listings under ANDA 075352
Product	Strength	Form · route	Labeler	Product NDC
Selegiline Hydrochloride	Selegiline hydrochloride 5 mg/1	CapsuleOral	Marlex Pharmaceuticals, Inc.	10135-737
Selegiline Hydrochloride	Selegiline hydrochloride 5 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2676