Bromocriptine Mesylate Micronize Powder
NDC Package 84644-003-00

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package 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 powders is bromocriptine is used alone or with other medications (such as levodopa) to treat Parkinson's disease. This formulation utilizes a powder delivery system. Marketed by Tapi Czech Industries S.r.o., this product is identified by NDC 84644-003.

Identification & Billing

NDC Package Code
84644-003-00
Package Description
1 kg in 1 CARTON
Product Code
84644-003
11-Digit Billing Format
84644000300

Clinical Specifications

Proprietary Name
Bromocriptine Mesylate Micronize
Non-Proprietary Name
Bromocriptine Mesylate Micronize
Substance Name
Bromocriptine Mesylate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
BROMOCRIPTINE MESYLATE 100 kg/100kg
Usage Information
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.

Regulatory & Marketing

Labeler Name
Tapi Czech Industries S.r.o.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
12-29-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 84644-003-00 identifies a specific commercial package of 1 kg in 1 carton of Bromocriptine Mesylate Micronize (UNFINISHED drug), a bulk ingredient labeled by Tapi Czech Industries S.r.o.. This powder is formulated for use and contains bromocriptine mesylate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Tapi Czech Industries S.r.o. on December 29, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Tapi Czech Industries S.r.o. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84644000300. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
84644-003-00
11-Digit CMS (5-4-2)
84644-0003-00

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.