NDC Package 0591-2132-01 Doxylamine Succinate And Pyridoxine Hydrochloride

Tablet, Delayed Release 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:
0591-2132-01
Package Description:
100 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code:
Proprietary Name:
Doxylamine Succinate And Pyridoxine Hydrochloride
Non-Proprietary Name:
Doxylamine Succinate And Pyridoxine Hydrochloride
Substance Name:
Doxylamine Succinate; Pyridoxine Hydrochloride
Usage Information:
Doxylamine succinate and pyridoxine hydrochloride delayed-release tabletsĀ 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 tabletsĀ have not been studied in women with hyperemesis gravidarum.
11-Digit NDC Billing Format:
00591213201
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to 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
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Actavis Pharma, Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    No
    FDA Application Number:
    ANDA205811
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-21-2019
    Listing Expiration Date:
    12-31-2024
    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.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0591-2132-01?

    The NDC Packaged Code 0591-2132-01 is assigned to a package of 100 tablet, delayed release in 1 bottle of Doxylamine Succinate And Pyridoxine Hydrochloride, a human prescription drug labeled by Actavis Pharma, Inc.. The product's dosage form is tablet, delayed release and is administered via oral form.

    Is NDC 0591-2132 included in the NDC Directory?

    Yes, Doxylamine Succinate And Pyridoxine Hydrochloride with product code 0591-2132 is active and included in the NDC Directory. The product was first marketed by Actavis Pharma, Inc. on June 21, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0591-2132-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 0591-2132-01?

    The 11-digit format is 00591213201. 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 4-4-2 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
    4-4-20591-2132-015-4-200591-2132-01