NDC Package 71335-2673-1 Selegiline Hydrochloride

Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
71335-2673-1
Package Description:
30 CAPSULE in 1 BOTTLE
Product Code:
Proprietary Name:
Selegiline Hydrochloride
Non-Proprietary Name:
Selegiline Hydrochloride
Substance Name:
Selegiline Hydrochloride
Usage Information:
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/carbidopa dose, the amount of ‘off’ time, and patient self-rating of treatment success. Beneficial effects were also observed on other measures of treatment success (e.g., measures of reduced end of dose akinesia, decreased tremor and sialorrhea, improved speech and dressing ability and improved overall disability as assessed by walking and comparison to previous state).
11-Digit NDC Billing Format:
71335267301
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Bryant Ranch Prepack
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
Sample Package:
No
FDA Application Number:
ANDA206803
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
04-02-2019
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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Frequently Asked Questions

What is NDC 71335-2673-1?

The NDC Packaged Code 71335-2673-1 is assigned to a package of 30 capsule in 1 bottle of Selegiline Hydrochloride, a human prescription drug labeled by Bryant Ranch Prepack. The product's dosage form is capsule and is administered via oral form.

Is NDC 71335-2673 included in the NDC Directory?

Yes, Selegiline Hydrochloride with product code 71335-2673 is active and included in the NDC Directory. The product was first marketed by Bryant Ranch Prepack on April 02, 2019 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 71335-2673-1?

The 11-digit format is 71335267301. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-171335-2673-15-4-271335-2673-01