Bromocriptine Mesylate Micronize Powder
NDC 84644-003

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 84644-003?
  4. Bromocriptine Mesylate Micronize Uses
  5. Active Ingredients

Product Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Bromocriptine Mesylate Micronize is a BULK INGREDIENT-approved product labeled by Tapi Czech Industries S.r.o.. Bromocriptine is used alone or with other medications (such as levodopa) to treat Parkinson's disease. It is supplied as a powder. This product entry covers the primary NDC 84644-003 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
84644-003
Proprietary Name:
Bromocriptine Mesylate Micronize
Non-Proprietary Name: [1]
Bromocriptine Mesylate Micronize
Substance Name: [2]
Bromocriptine Mesylate
NDC Directory Status:
Bulk Ingredient
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

Labeler & Regulatory Data

Labeler Name: [5]
Tapi Czech Industries S.r.o.
Labeler Code:
84644
Marketing Category: [8]
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.

Marketing Timeline

Start Marketing Date: [9]
12-29-2017
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes

Code Structure Chart

Product Details

What is NDC 84644-003?

The NDC code 84644-003 is assigned by the FDA to the product Bromocriptine Mesylate Micronize. It is commonly known by its generic name, bromocriptine mesylate micronize. This pharmaceutical product is labeled by Tapi Czech Industries S.r.o. and is currently categorized as listed product. The medication is a powder. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 84644-003-00. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Bromocriptine is used alone or with other medications (such as levodopa) to treat Parkinson's disease. It can improve your ability to move and can decrease shakiness (tremor), stiffness, slowed movement, and unsteadiness. It may also decrease the number of episodes of not being able to move ("on-off syndrome"). Bromocriptine is also used to treat high levels of a certain hormone made by the body (prolactin). High levels of prolactin may cause problems such as unwanted breast milk, missed/stopped periods, difficulty becoming pregnant, decreased sperm production, and decreased sexual ability. Bromocriptine may be used to treat a type of tumor which causes the high levels of prolactin (prolactin-secreting adenomas). It can help to reduce the tumor size. Bromocriptine is not recommended for stopping unwanted breast milk after pregnancy, miscarriage, or abortion because of possible serious side effects (such as high blood pressure, seizure, heart attack, stroke). Bromocriptine is also used to treat high levels of growth hormone (acromegaly). Bromocriptine is an ergot medication that works by acting like a certain natural substance (dopamine) in the brain. It also prevents the release of certain hormones (growth hormone, prolactin). Bromocriptine can lower these hormone levels, but it does not cure the causes of the increased levels.

What are Active Ingredients of this product?

An 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.

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Product & Regulatory Definitions
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.
What is the Substance Name? An 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.
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.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
What is an Unfinished Product? This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.