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Prograf

Tacrolimus · Granule, for Suspension

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Prograf
Generic name
Tacrolimus
Dosage form
Granule, for Suspension
Route
Oral
Marketing category
NDA · NDA
Labeler
Astellas Pharma US, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Tacrolimus .2 mg/1 108513 View
Tacrolimus 1 mg/1 108513 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Granule, for Suspension
Route of administration
Oral
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Calcineurin Inhibitor Immunosuppressant [EPC] EPC All 20 members
Calcineurin Inhibitors [MoA] MoA All 20 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
210115
Application type
NDA · New Drug Application
Approval date
May 24, 2018
Sponsor
ASTELLAS
Products on application
2
Submissions recorded
7
Products approved under application 210115.
Product Trade name Form Strength Ingredient Status TE Flags
210115-001 PROGRAF FOR SUSPENSION TACROLIMUS Prescription — RLD
210115-002 PROGRAF FOR SUSPENSION TACROLIMUS Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Regulatory exclusivity periods.
Code Expires Product
ODE-360 July 16, 2028 001
ODE-360 July 16, 2028 002

Approval history

Source: Drugs@FDA
Most recent submissions on application 210115.
Type No. Action Status Date Review
Supplement 7 Labeling Approved September 14, 2023 Standard
Supplement 6 Labeling Approved November 22, 2022 Standard
Supplement 5 Efficacy Approved July 16, 2021 Priority
Supplement 4 Labeling Approved December 30, 2020 Standard
Supplement 2 Labeling Approved June 11, 2019 Standard
Supplement 1 Labeling Approved December 2, 2018 Standard
Original application 1 Type 3 - New Dosage Form Approved May 24, 2018 Standard

Review documents

  • 0 · Supplement · September 15, 2023
  • 0 · Supplement · September 15, 2023
  • 0 · Supplement · November 25, 2022
  • 0 · Supplement · November 23, 2022
  • 0 · Supplement · November 23, 2022
  • 0 · Supplement · June 13, 2022
  • 0 · Supplement · July 19, 2021
  • 0 · Supplement · July 16, 2021
  • 0 · Supplement · December 31, 2020
  • 0 · Supplement · December 31, 2020
  • 0 · Supplement · June 12, 2019
  • 0 · Supplement · December 7, 2018
  • 0 · Original application · November 28, 2018
  • 0 · Original application · May 29, 2018
  • 0 · Original application · May 29, 2018

Adverse event reports

Source: openFDA FAERS
156,017
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: TACROLIMUS. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0469-1230-50 0469-1230 Astellas Pharma US, Inc. 50 PACKET in 1 CARTON (0469-1230-50) / 1 GRANULE, FOR SUSPENSION in 1 PACKET May 24, 2018
0469-1330-50 0469-1330 Astellas Pharma US, Inc. 50 PACKET in 1 CARTON (0469-1330-50) / 1 GRANULE, FOR SUSPENSION in 1 PACKET May 24, 2018
0469-1230 0469-1230 Astellas Pharma US, Inc. — May 24, 2018
0469-1330 0469-1330 Astellas Pharma US, Inc. — May 24, 2018

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.