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PIMECROLIMUS

ANDA

PIMECROLIMUS | A209345 | ACTAVIS LABORATORIES UT INC INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ELIDEL(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 3 NDCs

Highest NADAC/Unit

$3.38

per gm

Lowest NADAC/Unit

$3.19

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00591294430PIMECROLIMUS 1% CREAM	$3.38	GM	Generic	—	2026-08-19
00591294487PIMECROLIMUS 1% CREAM	$3.25	GM	Generic	—	2026-08-19
00591294460PIMECROLIMUS 1% CREAM	$3.19	GM	Generic	—	2026-08-19

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

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (3 FSS)

Lowest Price

$157.09

Highest Price

$524.07

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00591-2944-30PIMECROLIMUS 1% CREAM,TOP	$157.09	FSS	AvKare, LLC	06/14/2028
00591-2944-60PIMECROLIMUS 1% CREAM,TOP	$314.20	FSS	AvKare, LLC	06/14/2028
00591-2944-87PIMECROLIMUS 1% CREAM,TOP	$524.07	FSS	AvKare, LLC	06/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain7 active DMFs

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

BIOCON LTDPIMECROLIMUS USP

DMF 293902015

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDPIMECROLIMUS INTERMEDIATE ASCOMYCIN

DMF 294332015

MEDICHEM SAPIMECROLIMUS (MED 201445/E)

DMF 294812015

CONCORD BIOTECH LTDPIMECROLIMUS USP

DMF 296582015

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDPIMECROLIMUS (NON-STERILE, API)

DMF 300902015

CURIA ITALY SRLPIMECROLIMUS

DMF 323482017

CHENGDU YACHT BIOTECHNOLOGY CO LTDPIMECROLIMUS

DMF 419462025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 22, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Dec 27, 2018

No patent or exclusivity listings for this strength.