0378-1712 NDC - PRAMIPEXOLE DIHYDROCHLORIDE ()

Drug Information

  • Product NDC: 0378-1712
  • Proprietary Name: Pramipexole Dihydrochloride
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Mylan Pharmaceuticals Inc.
Product Type:
FDA Application Number: ANDA077854
Marketing Category: ANDA
Start Marketing Date:11/4/2010
End Marketing Date:8/31/2012

Package Information

No. Package Code Package Description Billing Unit
10378-1712-05500 TABLET in 1 BOTTLE, PLASTIC (0378-1712-05)EA
20378-1712-7790 TABLET in 1 BOTTLE, PLASTIC (0378-1712-77)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0378-1712The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
PROPRIETARY NAMEPramipexole DihydrochlorideThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE11/4/2010The translation of the route code submitted by the firm, indicating route of administration.
END MARKETING DATE8/31/2012This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct 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.
APPLICATION NUMBERANDA077854This 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.
LABELER NAMEMylan Pharmaceuticals Inc.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 11/21/2025

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