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  4. NDC Product Code: 69452-476 Bromocriptine Mesylate

NDC 69452-476 Bromocriptine Mesylate

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 69452-476?
  5. Bromocriptine Mesylate Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 69452-476 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
69452-476
Proprietary Name:
Bromocriptine Mesylate
Product Type: [3]
Labeler Name: [5]
Bionpharma Inc.
Labeler Code:
69452
Product Label ID:
2d04778c-ec3f-6a61-e063-6294a90ae449
FDA Application Number: [6]
NDA017962
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
04-01-2025
End Marketing Date: [10]
04-01-2025
Listing Expiration Date: [11]
04-01-2025
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - OFF-WHITE)
Shape:
ROUND (C48348)
Size(s):
8 MM
Imprint(s):
E280;25
Score:
2

Code Structure Chart

Product Details

What is NDC 69452-476?

The NDC code 69452-476 is assigned by the FDA to the product Bromocriptine Mesylate which is product labeled by Bionpharma Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 69452-476-13 30 tablet in 1 bottle , 69452-476-20 100 tablet in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Bromocriptine Mesylate?

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.

Which are Bromocriptine Mesylate UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Bromocriptine Mesylate Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

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Product Footnotes

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

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[11] 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.

[12] 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".