Viewing data from:

TACROLIMUS

ANDA

TACROLIMUS | A200744 | FOUGERA PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: PROTOPIC(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 6 NDCs

Highest NADAC/Unit

$0.9615

per gm

Lowest NADAC/Unit

$0.7954

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00168041699TACROLIMUS 0.1% OINTMENT	$0.9615	GM	Generic	—	2026-08-19
00168041630TACROLIMUS 0.1% OINTMENT	$0.9560	GM	Generic	—	2026-08-19
00168041660TACROLIMUS 0.1% OINTMENT	$0.9192	GM	Generic	—	2026-08-19
00168041760TACROLIMUS 0.03% OINTMENT	$0.9036	GM	Generic	—	2026-08-19
00168041730TACROLIMUS 0.03% OINTMENT	$0.8830	GM	Generic	—	2026-08-19
00168041799TACROLIMUS 0.03% OINTMENT	$0.7954	GM	Generic	—	2026-08-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain24 active DMFs7 inactive

18 active API suppliers hold Drug Master Files for this ingredient.

ASTELLAS PHARMA INCTACROLIMUS (FK506) DRUG SUBSTANCE

DMF 168332003

BIOCON LTDTACROLIMUS USP

DMF 184422005

CONCORD BIOTECH LTDTACROLIMUS USP

DMF 189082005

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDTACROLIMUS

DMF 189852005

LEK PHARMACEUTICALS DDTACROLIMUS

DMF 199792006

FUJIAN KERUI PHARMACEUTICAL CO LTDTACROLIMUS, NON-STERILE, BULK DRUG SUBSTANCE

DMF 218082008

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDTACROLIMUS SD20

DMF 232132009

HISUN PHARMACEUTICAL HANGZHOU CO LTDTACROLIMUS USP

DMF 272022013

MURLI KRISHNA PHARMA PVT LTDTACROLIMUS PELLETS 5.0% W/W

DMF 276262013

APOTEX INCTACROLIMUS USP

DMF 280652014

TAPI NL BVTACROLIMUS

DMF 285242014

BIOCON LTDTACROLIMUS GRANULES 20% W/W

DMF 297862015

CKD BIO CORPTACROLIMUS NON STERILE API

DMF 310972016

HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDTACROLIMUS USP

DMF 312252016

LEK PHARMACEUTICALS DDTACROLIMUS (PROCESS II)

DMF 340632020

NORTH CHINA PHARMACEUTICAL HUASHENG CO LTDTACROLIMUS USP

DMF 342702020

CONCORD BIOTECH LTDTACROLIMUS USP (PROCESS II)

DMF 344912020

FARMHISPANIA SATACROLIMUS USP

DMF 358522021

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDTACROLIMUS (PROCESS B)

DMF 383102023

LUNAN NEW TIME BIO-TECH CO LTDTACROLIMUS

DMF 389852023

BIOCON LTDTACROLIMUS USP (PROCESS II)

DMF 395732024

WUXI FORTUNE PHARMACEUTICAL CO LTDTACROLIMUS

DMF 398162024

CHENGDU YACHT BIOTECHNOLOGY CO LTDTACROLIMUS

DMF 404482024

FISHFA BIOGENICS (A DIV OF FISHFA RUBBERS LTD)TACROLIMUS USP

DMF 418282025

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveTACROLIMUS (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 190722005

HANGZHOU HUADONG MEDICINE GROUP BIOTECHNOLOGY INSTITUTE CO LTDInactiveTACROLIMUS

DMF 203902007

ANTIBIOTICOS SPAInactiveTACROLIMUS MONOHYDRATE

DMF 222542008

BIOCON LTDInactiveTACROLIMUS (PRODUCT CODE 8000255)

DMF 233652009

JOYANG LABORATORIESInactiveTacrolimus

DMF 346302020

LUNAN NEW TIME BIO-TECH CO LTDInactiveTACROLIMUS USP

DMF 379822023

FISHFA BIOGENICS (A DIV OF FISHFA RUBBERS LTD)InactiveTACROLIMUS USP

DMF 396672024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 10, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.03%

0 patents0 exclusivities▴

OINTMENT;TOPICAL | Approved: Sep 9, 2014

No patent or exclusivity listings for this strength.

#002 — 0.1%

0 patents0 exclusivities▾

OINTMENT;TOPICAL | Approved: Sep 9, 2014