43598-749 NDC - SAPROPTERIN DIHYDROCHLORIDE

Drug Information

  • Product NDC: 43598-749
  • Proprietary Name:
  • Non Proprietary Name: Sapropterin Dihydrochloride
  • Active Ingredient(s): 100 mg/1 SAPROPTERIN DIHYDROCHLORIDE
  • Administration Route(s):
  • Dosage Form(s): TABLET

Labeler Information

Field Name Field Value
Labeler Name: Dr. Reddy's Laboratories Inc.
Product Type: DRUG FOR FURTHER PROCESSING
FDA Application Number:
Marketing Category: DRUG FOR FURTHER PROCESSING
Start Marketing Date:8/1/2020
End Marketing Date:10/31/2023

Package Information

No. Package Code Package Description Billing Unit
143598-749-041 BOTTLE in 1 CARTON (43598-749-04) / 120 TABLET in 1 BOTTLE
243598-749-138000 BOTTLE in 1 CASE (43598-749-13) / 120 TABLET in 1 BOTTLE

NDC Record

Field Name Field Value Definition
PRODUCT NDC43598-749The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
START MARKETING DATE10/1/2020This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMEDr. Reddys Laboratories Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC43598-749The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
START MARKETING DATE8/1/2020This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEDRUG FOR FURTHER PROCESSINGProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMEDr. Reddy's Laboratories Inc.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 12/6/2025

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