54868-3335 NDC - GLUCOTROL XL ()

Drug Information

  • Product NDC: 54868-3335
  • Proprietary Name: Glucotrol XL
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Physicians Total Care, Inc.
Product Type:
FDA Application Number: NDA020329
Marketing Category: NDA
Start Marketing Date:8/1/1994

Package Information

No. Package Code Package Description Billing Unit
154868-3335-030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-3335-0)EA
254868-3335-115 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-3335-1)EA
354868-3335-2100 TABLET, EXTENDED RELEASE in 1 BOTTLE (54868-3335-2)EA
454868-3335-360 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-3335-3)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC54868-3335The 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.
PROPRIETARY NAMEGlucotrol XLThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE8/1/1994This 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.
APPLICATION NUMBERNDA020329This 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 NAMEPhysicians Total Care, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 7/4/2025

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