NDC 0007-3373-61 Coreg CR

Carvedilol Phosphate

NDC Package Code 0007-3373-61

Field Name Field Value
NDC Code 0007-3373-61
Proprietary Name Coreg CR Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Carvedilol Phosphate Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
11-Digit NDC Billing Format 00007337361 Additional informationCallout TooltipNDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Product Type Human Prescription Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates 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.
Labeler Name Glaxosmithkline Llc
Dosage Form Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route(s)
  • Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacological Class(es)
  • Adrenergic alpha-Antagonists - [MoA] (Mechanism of Action)
  • Adrenergic beta1-Antagonists - [MoA] (Mechanism of Action)
  • Adrenergic beta2-Antagonists - [MoA] (Mechanism of Action)
  • alpha-Adrenergic Blocker - [EPC] (Established Pharmacologic Class)
  • beta-Adrenergic Blocker - [EPC] (Established Pharmacologic Class)
Sample Package No Additional informationCallout TooltipSample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category NDA - A product marketed under an approved New Drug Application. Additional informationCallout TooltipWhat is the Marketing Category?
Product 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.
FDA Application Number NDA022012 Additional informationCallout TooltipWhat is the FDA Application Number?
This 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.
Start Marketing Date 02-20-2007 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2019 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

The NDC Code 0007-3373-61 is assigned to Coreg CR, a human prescription drug labeled by Glaxosmithkline Llc. The product's dosage form is capsule, extended release and is administered via oral form.

Code Structure
  • 0007 - Glaxosmithkline Llc
    • 0007-3373 - Coreg
      • 0007-3373-61 - 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

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.

Pill Identification

24 HR carvedilol phosphate 80 MG Extended Release Oral Capsule [Coreg]

24 HR carvedilol phosphate 80 MG Extended Release Oral Capsule [Coreg]
Image Labeler: GlaxoSmithKline LLC

Physical Characteristics

What does coreg cr look like?
Coreg CR may look like a white capsule shaped capsule, extended release; approximately 21 millimeters in size. The medicine is imprinted with black printed code(s) GSK and COREG and CR and 80 and mg.

Size: 21 mm
Color: WHITE
Imprint: GSK;COREG;CR;80;mg
Imprint Color: BLACK
Imprint Type: PRINTED

Active and Inactive Ingredients

Active Ingredients: carvedilol phosphate 80 mg

Inactive Ingredients: crospovidone, hydrogenated castor oil, magnesium stearate, cellulose, microcrystalline, povidone

Other Product Packages

The following packages are also available for Coreg with product NDC 0007-3373.

NDC Package CodePackage Description

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