63868-154 NDC - LORATADINE AND PSEUDOEPHEDRINE SULFATE ()

Drug Information

  • Product NDC: 63868-154
  • Proprietary Name: Loratadine and Pseudoephedrine Sulfate
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Chain Drug Marketing Association Inc.
Product Type:
FDA Application Number: ANDA076557
Marketing Category: ANDA
Start Marketing Date:11/17/2004

Package Information

No. Package Code Package Description Billing Unit
163868-154-1010 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (63868-154-10)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC63868-154This is the date that the labeler indicates was the start of its marketing of the drug product.
PROPRIETARY NAMELoratadine and Pseudoephedrine SulfateProduct 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.
START MARKETING DATE11/17/2004This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
MARKETING CATEGORY NAMEANDAName of Company corresponding to the labeler code segment of the Product NDC.
APPLICATION NUMBERANDA076557This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEChain Drug Marketing Association Inc.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 11/21/2025

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