Bromocriptine Mesylate Capsule
NDC Package 65841-654-06

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

Package Information

Bromocriptine Mesylate capsules is bromocriptine is used alone or with other medications (such as levodopa) to treat Parkinson's disease. This formulation utilizes a capsule delivery system. Marketed by Zydus Lifesciences Limited, this product is identified by NDC 65841-654 and is authorized under FDA application ANDA078899.

Identification & Billing

NDC Package Code
65841-654-06
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
65841-654
11-Digit Billing Format
65841065406
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bromocriptine Mesylate
Non-Proprietary Name
Bromocriptine Mesylate
Substance Name
Bromocriptine Mesylate
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BROMOCRIPTINE MESYLATE 5 mg/1
Pharmacologic Class
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
Zydus Lifesciences Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA078899
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-23-2009
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65841-654). Click a package code to view its specific billing and regulatory data.

65841-654-01
100 CAPSULE in 1 BOTTLE

* 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 65841-654-06 identifies a specific commercial package of 30 capsule in 1 bottle of Bromocriptine Mesylate, a human prescription drug labeled by Zydus Lifesciences Limited. This capsule is formulated for oral 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 Zydus Lifesciences Limited on January 23, 2009. 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 Zydus Lifesciences Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65841065406. 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)
65841-654-06
11-Digit CMS (5-4-2)
65841-0654-06

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