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ATROPINE SULFATE

ANDA

ATROPINE SULFATE | A215624 | APOTEX INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ATROPINE SULFATE(TE code: AT1)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$13.30

per ml

Lowest NADAC/Unit

$4.08

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
60505622600ATROPINE 1% EYE DROPS	$13.30	ML	Generic	—	2026-06-17
60505622601ATROPINE 1% EYE DROPS	$5.84	ML	Generic	—	2026-06-17
60505622602ATROPINE 1% EYE DROPS	$4.08	ML	Generic	—	2026-06-17

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

$20.33

Highest Price

$100.32

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
60505-6226-00ATROPINE SO4 1% SOLN,OPH	$20.33	FSS	Golden State Medical Supply, Inc.	06/14/2028
60505-6226-01ATROPINE SO4 1% SOLN,OPH	$33.03	FSS	Golden State Medical Supply, Inc.	06/14/2028
60505-6226-02ATROPINE SO4 1% SOLN,OPH	$100.32	FSS	Golden State Medical Supply, Inc.	06/14/2028

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

API Supply Chain12 active DMFs1 inactive

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

CURIA WISCONSIN INCATROPINE SULFATE, USP

DMF 284232014

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTDATROPINE SULFATE

DMF 289782014

ROLABO OUTSOURCING SLATROPINE SULFATE USP

DMF 293962015

SCL LIFESCIENCES LTDATROPINE SULFATE USP

DMF 296052015

RESONANCE LABORATORIES PVT LTDATROPINE SULFATE

DMF 298032015

MINSHENG GROUP SHAOXING PHARMACEUTICAL CO LTDATROPINE SULFATE

DMF 302272016

C-SQUARED PHARMA LTDATROPINE SULFATE USP

DMF 306052016

ALCHEM INTERNATIONAL PRIVATE LTDATROPINE SULFATE USP

DMF 312782016

MATRIX PHARMACORP PRIVATE LTDATROPINE SULFATE USP

DMF 322902017

SS PHARMA LLCATROPINE SULFATE MONOHYDRATE USP

DMF 337812019

HENAN PURUI PHARMACEUTICAL CO LTDATROPINE SULFATE

DMF 364842021

FLOWCHEM PHARMA PVT LTDATROPINE SULFATE USP

DMF 422992025

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveATROPINE SULFATE

DMF 54941984

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 20, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

AT1

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Nov 26, 2021

No patent or exclusivity listings for this strength.