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Drug Information

Product NDC: 0007-3371

Proprietary Name: COREG

Non Proprietary Name: carvedilol phosphate

Active Ingredient(s):

Administration Route(s): ORAL


Pharmacy Class(es):
  • Adrenergic alpha-Antagonists [MoA];
  • Adrenergic beta1-Antagonists [MoA];
  • Adrenergic beta2-Antagonists [MoA];
  • alpha-Adrenergic Blocker [EPC];
  • beta-Adrenergic Blocker [EPC]

Labeler Information

Labeler Name: GlaxoSmithKline LLC
FDA Application Number: NDA022012
Marketing Category: NDA
Start Marketing Date:2/6/2007
End Marketing Date:9/30/2023

Package Information

No. Package Code Package Description Billing Unit
10007-3371-1330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3371-13)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0007-3371The 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.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMECOREGThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXCRA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAMEcarvedilol phosphateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECAPSULE, EXTENDED RELEASEThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE2/6/2007This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE9/30/2023This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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 under Structured Product Labeling Resources.
APPLICATION NUMBERNDA022012This 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 NAMEGlaxoSmithKline LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECARVEDILOL PHOSPHATEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESAdrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC] 

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This page was last updated on: 2/1/2023