astagraf xl

Generic: tacrolimus extended-release capsules

Labeler: astellas pharma us, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name astagraf xl
Generic Name tacrolimus extended-release capsules
Labeler astellas pharma us, inc.
Dosage Form CAPSULE, COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

tacrolimus .5 mg/1

Manufacturer
Astellas Pharma US, Inc.

Identifiers & Regulatory

Product NDC 0469-0647
Product ID 0469-0647_4ecfe626-bf9c-4889-a1d4-64b03d60eaf8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204096
Listing Expiration 2027-12-31
Marketing Start 2013-07-19

Pharmacologic Class

Classes
calcineurin inhibitor immunosuppressant [epc] calcineurin inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04690647
Hyphenated Format 0469-0647

Supplemental Identifiers

RxCUI
1431971 1431977 1431980 1431982 1431985 1431987
UNII
WM0HAQ4WNM

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name astagraf xl (source: ndc)
Generic Name tacrolimus extended-release capsules (source: ndc)
Application Number NDA204096 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0469-0647-73) / 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE
source: ndc

Packages (1)

0469-0647-73 1 BOTTLE in 1 CARTON (0469-0647-73) / 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE

Ingredients (1)

tacrolimus (.5 mg/1)

Linked Drug Pages (1)

ASTAGRAF XL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4ecfe626-bf9c-4889-a1d4-64b03d60eaf8", "openfda": {"unii": ["WM0HAQ4WNM"], "rxcui": ["1431971", "1431977", "1431980", "1431982", "1431985", "1431987"], "spl_set_id": ["550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e"], "manufacturer_name": ["Astellas Pharma US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0469-0647-73)  / 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "0469-0647-73", "marketing_start_date": "20130719"}], "brand_name": "ASTAGRAF XL", "product_id": "0469-0647_4ecfe626-bf9c-4889-a1d4-64b03d60eaf8", "dosage_form": "CAPSULE, COATED, EXTENDED RELEASE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "0469-0647", "generic_name": "tacrolimus extended-release capsules", "labeler_name": "Astellas Pharma US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ASTAGRAF XL", "active_ingredients": [{"name": "TACROLIMUS", "strength": ".5 mg/1"}], "application_number": "NDA204096", "marketing_category": "NDA", "marketing_start_date": "20130719", "listing_expiration_date": "20271231"}