0574-0827 NDC - TESTOSTERONE CYPIONATE ()

Drug Information

  • Product NDC: 0574-0827
  • Proprietary Name: Testosterone Cypionate
  • Non Proprietary Name:
  • Active Ingredient(s): 200 mg/mL TESTOSTERONE CYPIONATE
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): Androgen Receptor Agonists [MoA]; Androgen [EPC]; Androstanes [CS]

Labeler Information

Field Name Field Value
Labeler Name: Paddock Laboratories, LLC
Product Type:
FDA Application Number: ANDA091244
Marketing Category: ANDA
Start Marketing Date:5/1/2014
End Marketing Date:7/27/2015
DEA Schedule:CIII

Package Information

No. Package Code Package Description Billing Unit
10574-0827-011 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASSML
20574-0827-101 VIAL, GLASS in 1 CARTON (0574-0827-10) / 10 mL in 1 VIAL, GLASSML
30574-0827-101 VIAL, GLASS in 1 CARTON (0574-0827-10) / 10 mL in 1 VIAL, GLASSML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0574-0827The 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.
PROPRIETARY NAMETestosterone CypionateThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE5/1/2014This 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 NUMBERANDA091244This 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 NAMEPaddock Laboratories, LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC0574-0827The 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.
PROPRIETARY NAMETestosterone CypionateThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE5/1/2014This 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 NUMBERANDA091244This 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 NAMEPadagis US LLCName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 5/26/2025

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