Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release
NDC Package 0591-2132-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Doxylamine Succinate And Pyridoxine Hydrochloride tablets is doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.Limitations of UseDoxylamine succinate and pyridoxine hydrochloride delayed-release tablets have not been studied in women with hyperemesis gravidarum. This formulation utilizes a tablet, delayed release delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-2132 and is authorized under FDA application ANDA205811.

Identification & Billing

NDC Package Code
0591-2132-01
Package Description
100 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
0591-2132
11-Digit Billing Format
00591213201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 1375948 - doxylamine succinate 10 MG / pyridoxine HCl 10 MG Delayed Release Oral Tablet
  • RxCUI: 1375948 - doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG Delayed Release Oral Tablet
  • RxCUI: 1375948 - doxylamine succinate 10 MG / vitamin B6 Hydrochloride 10 MG Delayed Release Oral Tablet
  • RxCUI: 1375948 - doxylamine succinate 10 MG / vit-B6 Hydrochloride 10 MG Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Doxylamine Succinate And Pyridoxine Hydrochloride
Non-Proprietary Name
Doxylamine Succinate And Pyridoxine Hydrochloride
Substance Name
Doxylamine Succinate; Pyridoxine Hydrochloride
Dosage Form
Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.Limitations of UseDoxylamine succinate and pyridoxine hydrochloride delayed-release tablets have not been studied in women with hyperemesis gravidarum.

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA205811
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-21-2019
Listing Expiration
12-31-2026
Exclude Flag
N
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0591-2132-01 identifies a specific commercial package of 100 tablet, delayed release in 1 bottle of Doxylamine Succinate And Pyridoxine Hydrochloride, a human prescription drug labeled by Actavis Pharma, Inc.. This tablet, delayed release is formulated for oral use and contains doxylamine succinate; pyridoxine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Actavis Pharma, Inc. on June 21, 2019. The current certification is valid through December 31, 2026.

How is this Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591213201. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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 (4-4-2)
0591-2132-01
11-Digit CMS (5-4-2)
00591-2132-01

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