NDC 0115-1251 Carvedilol Phosphate

Carvedilol Phosphate

NDC Product Code 0115-1251

NDC CODE: 0115-1251

Proprietary Name: Carvedilol Phosphate What 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 What 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Carvedilol is used to treat high blood pressure and heart failure. It is also used after a heart attack to improve the chance of survival if your heart is not pumping well. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This drug works by blocking the action of certain natural substances in your body, such as epinephrine, on the heart and blood vessels. This effect lowers your heart rate, blood pressure, and strain on your heart. Carvedilol belongs to a class of drugs known as alpha and beta blockers.

NDC Code Structure

NDC 0115-1251-01

Package Description: 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

NDC 0115-1251-03

Package Description: 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

NDC 0115-1251-08

Package Description: 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

NDC 0115-1251-10

Package Description: 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

NDC Product Information

Carvedilol Phosphate with NDC 0115-1251 is a a human prescription drug product labeled by Amneal Pharmaceuticals Of New York Llc. The generic name of Carvedilol Phosphate is carvedilol phosphate. The product's dosage form is capsule, extended release and is administered via oral form.

Labeler Name: Amneal Pharmaceuticals Of New York 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.

Product Type: Human Prescription Drug What 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.

Carvedilol Phosphate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CARVEDILOL PHOSPHATE 80 mg/1

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • 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)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Amneal Pharmaceuticals Of New York Llc
Labeler Code: 0115
FDA Application Number: ANDA204448 What 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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What 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.

Start Marketing Date: 06-01-2020 What 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: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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