NDC 69844-042 Pramipexole Dihydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
69844-042
Proprietary Name:
Pramipexole Dihydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Graviti Pharmaceuticals Private Limited
Labeler Code:
69844
Start Marketing Date: [9]
04-06-2020
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
OVAL (C48345)
Size(s):
8 MM
Imprint(s):
O;E;A28
Score:
2

Product Packages

NDC Code 69844-042-01

Package Description: 90 TABLET in 1 BOTTLE

Product Details

What is NDC 69844-042?

The NDC code 69844-042 is assigned by the FDA to the product Pramipexole Dihydrochloride which is product labeled by Graviti Pharmaceuticals Private Limited. The product's dosage form is . The product is distributed in a single package with assigned NDC code 69844-042-01 90 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 Pramipexole Dihydrochloride?

Pramipexole is used alone or with other medications to treat Parkinson's disease. It can improve your ability to move and 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"). This medication is also used to treat a certain medical condition (restless legs syndrome - RLS) that causes an unusual urge to move the legs. Symptoms usually occur at night along with uncomfortable/unpleasant feelings in the legs. This medication can decrease these symptoms and thereby improve sleep. Pramipexole is a dopamine agonist that works by helping to restore the balance of a certain natural substance (dopamine) in the brain.

Which are Pramipexole Dihydrochloride UNII Codes?

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

Which are Pramipexole Dihydrochloride 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:

What is the NDC to RxNorm Crosswalk for Pramipexole Dihydrochloride?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 858625 - pramipexole dihydrochloride 0.75 MG Oral Tablet
  • RxCUI: 858625 - pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet
  • RxCUI: 859040 - pramipexole dihydrochloride 0.25 MG Oral Tablet
  • RxCUI: 859040 - pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral Tablet
  • RxCUI: 859044 - pramipexole dihydrochloride 0.5 MG Oral Tablet

* Please review the disclaimer below.

Product Footnotes

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

[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.

[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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".