0469-0677 NDC - ASTAGRAF XL (TACROLIMUS EXTENDED-RELEASE CAPSULES)

Drug Information

Product NDC: 0469-0677

Proprietary Name: ASTAGRAF XL

Non Proprietary Name: tacrolimus extended-release capsules

Active Ingredient(s):
  • 1 mg/1 TACROLIMUS


Administration Route(s): ORAL

Dosage Form(s): CAPSULE, COATED, EXTENDED RELEASE

Pharmacy Class(es):
  • Calcineurin Inhibitor Immunosuppressant [EPC];
  • Calcineurin Inhibitors [MoA]

Labeler Information

Labeler Name: Astellas Pharma US, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA204096
Marketing Category: NDA
Start Marketing Date:7/19/2013

Package Information

No. Package Code Package Description Billing Unit
10469-0677-115 BLISTER PACK in 1 CARTON (0469-0677-11) > 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK
20469-0677-731 BOTTLE in 1 CARTON (0469-0677-73) > 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLEEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0469-0677The 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 NAMEHUMAN PRESCRIPTION DRUGIndicates 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.
PROPRIETARY NAMEASTAGRAF XLThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEtacrolimus extended-release capsulesThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECAPSULE, COATED, EXTENDED RELEASEThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE7/19/2013This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct 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 NUMBERNDA204096This 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 NAMEAstellas Pharma US, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMETACROLIMUSThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH1 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESCalcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 

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This page was last updated on: 2/19/2021