What is NDC 16571-659?

16571-659 is the product NDC for Selegiline Hydrochloride, Selegiline hydrochloride 5 mg/1 capsule, listed with the FDA by Rising Pharma Holdings, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Rising Pharma Holdings, Inc., NDC labeler code 16571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Selegiline Hydrochloride?

12 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Selegiline Hydrochloride NDC 16571-659

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-659Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0659Add 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
16571-659-06	16571065906	60 CAPSULE in 1 BOTTLE (16571-659-06)Marketed from Apr 2, 2019
16571-659-50	16571065950	500 CAPSULE in 1 BOTTLE (16571-659-50)Marketed from Apr 2, 2019

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: Rising Pharma Holdings, Inc.NDC labeler code 16571
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206803
Marketing start: Apr 2, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Monoamine Oxidase Inhibitors (Mechanism)Monoamine Oxidase-B Inhibitors (Mechanism)
Identifiers: Product ID 16571-659_102210a0-2a43-44c4-aedf-7741b84675edSPL ID 102210a0-2a43-44c4-aedf-7741b84675edSPL set ID 23c4481f-d150-40c6-addb-b3e454ca914fRxCUI 859186UNII 6W731X367QUPC 0316571659067
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

N416571065906 followed by a unit qualifier and the quantity

Package 16571-0659-06. 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 Aug 7, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Selegiline 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 levodopa/carb…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16571-659

What is NDC 16571-659?: 16571-659 is the product NDC for Selegiline Hydrochloride, Selegiline hydrochloride 5 mg/1 capsule, listed with the FDA by Rising Pharma Holdings, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Selegiline Hydrochloride.
What is the active ingredient?: Selegiline hydrochloride.
Who is the labeler?: Rising Pharma Holdings, Inc., NDC labeler code 16571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Selegiline Hydrochloride?: 12 other product NDCs are listed under this name. See all Selegiline Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Selegiline Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Selegiline Hydrochloride	Selegiline hydrochloride 5 mg/1	TabletOral	A2A Integrated Pharmaceuticals	73141-006	73141-0006-02
Selegiline Hydrochloride	Selegiline hydrochloride 5 mg/1	TabletOral	i3 Pharmaceuticals, LLC	72319-006	72319-0006-02
Selegiline Hydrochloride	Selegiline hydrochloride 5 mg/1	CapsuleOral	Marlex Pharmaceuticals, Inc.	10135-737	10135-0737-60
Selegiline Hydrochloride	Selegiline hydrochloride 5 mg/1	CapsuleOral	Novitium Pharma LLC	70954-504	70954-0504-1070954-0504-20
Selegiline Hydrochloride	Selegiline hydrochloride 5 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2676	71335-2676-01
Selegiline Hydrochloride	Selegiline hydrochloride 5 mg/1	CapsuleOral	Proficient Rx LP	71205-888	71205-0888-0071205-0888-1171205-0888-30+3 more
Selegiline Hydrochloride	Selegiline hydrochloride 5 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2673	71335-2673-01
Selegiline Hydrochloride	Selegiline hydrochloride 5 mg/1	CapsuleOral	Apotex Corp.	60505-0055	60505-0055-0160505-0055-0260505-0055-03
Selegiline Hydrochloride	Selegiline hydrochloride 5 mg/1	TabletOral	A-S Medication Solutions	50090-2918	50090-2918-00
Selegiline Hydrochloride	Selegiline hydrochloride 5 mg/1	TabletOral	Apotex Corp.	60505-3438	60505-3438-0360505-3438-08

All 13 Selegiline Hydrochloride NDCs

Other NDCs under ANDA 206803

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

FDA NDC Directory listings under ANDA 206803
Product	Strength	Form · route	Labeler	Product NDC
Selegiline Hydrochloride	Selegiline hydrochloride 5 mg/1	CapsuleOral	Proficient Rx LP	71205-888
Selegiline Hydrochloride	Selegiline hydrochloride 5 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2673