Rivastigmine Tartrate
NDC Package 75834-135-05

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Rivastigmine Tartrate is capsules are contraindicated in patients with:known hypersensitivity to rivastigmine, other carbamate derivatives or other components of the formulation [see Description (11)].a previous history of application site reaction with rivastigmine transdermal patch suggestive of allergic contact dermatitis, in the absence of negative allergy testing [see Warnings and Precautions (5.2)].Isolated cases of generalized skin reactions have been described in postmarketing experience [see Adverse Reactions (6.2)]. Marketed by Nivagen Pharmaceuticals, Inc., this product is identified by NDC 75834-135 and is authorized under FDA application ANDA203844.

Identification & Billing

NDC Package Code
75834-135-05
Package Description
500 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
11-Digit Billing Format
75834013505
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
500 EA

Clinical Specifications

Proprietary Name
Rivastigmine Tartrate
Dosage Form
-
Usage Information
Rivastigmine tartrate capsules are contraindicated in patients with:known hypersensitivity to rivastigmine, other carbamate derivatives or other components of the formulation [see Description (11)].a previous history of application site reaction with rivastigmine transdermal patch suggestive of allergic contact dermatitis, in the absence of negative allergy testing [see Warnings and Precautions (5.2)].Isolated cases of generalized skin reactions have been described in postmarketing experience [see Adverse Reactions (6.2)].

Regulatory & Marketing

Labeler Name
Nivagen Pharmaceuticals, Inc.
FDA Application #
ANDA203844
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-04-2017
End Marketing Date
08-31-2026
Listing Expiration
08-31-2026
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

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.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (75834-135). Click a package code to view its specific billing and regulatory data.

60 CAPSULE in 1 BOTTLE, PLASTIC

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 75834-135-05 identifies a specific commercial package of 500 capsule in 1 bottle, plastic of Rivastigmine Tartrate, labeled by Nivagen Pharmaceuticals, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Nivagen Pharmaceuticals, Inc. on September 04, 2017. The current certification is valid through August 31, 2026.

How is this Nivagen Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75834013505. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
75834-135-05
11-Digit CMS (5-4-2)
75834-0135-05

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.