63552-041 NDC - ALTEPLASE

Drug Information

  • Product NDC: 63552-041
  • Proprietary Name:
  • Non Proprietary Name: ALTEPLASE
  • Active Ingredient(s): 2.2 mg/2mL ALTEPLASE
  • Administration Route(s):
  • Dosage Form(s): INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Labeler Information

Field Name Field Value
Labeler Name: Patheon Manufacturing Services LLC
Product Type: DRUG FOR FURTHER PROCESSING
FDA Application Number:
Marketing Category: DRUG FOR FURTHER PROCESSING
Start Marketing Date:9/4/2001

Package Information

No. Package Code Package Description Billing Unit
163552-041-9999 VIAL in 1 TRAY (63552-041-99) / 6 mL in 1 VIAL

NDC Record

Field Name Field Value Definition
PRODUCT NDC63552-041The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEDRUG FOR FURTHER PROCESSINGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
NON PROPRIETARY NAMEALTEPLASEThe labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
DOSAGE FORM NAMEINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
START MARKETING DATE9/4/2001The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
MARKETING CATEGORY NAMEDRUG FOR FURTHER PROCESSINGThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
LABELER NAMEPatheon Manufacturing Services LLCThe translation of the dosage form Code submitted by the firm.
SUBSTANCE NAMEALTEPLASEThe translation of the route code submitted by the firm, indicating route of administration.
ACTIVE NUMERATOR STRENGTH2.2 
ACTIVE INGRED UNITmg/2mL 

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This page was last updated on: 4/14/2026

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