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GUANFACINE HYDROCHLORIDE

ANDA

GUANFACINE HYDROCHLORIDE | A200881 | ACTAVIS ELIZABETH LLC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: INTUNIV(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 4 NDCs

Highest NADAC/Unit

$0.1783

per ea

Lowest NADAC/Unit

$0.1325

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00228285511GUANFACINE HCL ER 4 MG TABLET	$0.1783	EA	Generic	—	2026-08-19
00228285311GUANFACINE HCL ER 3 MG TABLET	$0.1660	EA	Generic	—	2026-08-19
00228285111GUANFACINE HCL ER 2 MG TABLET	$0.1573	EA	Generic	—	2026-08-19
00228285011GUANFACINE HCL ER 1 MG TABLET	$0.1325	EA	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 | 1 NDC (1 FSS)

Lowest Price

$23.89

Highest Price

$23.89

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
42291-0324-01GUANFACINE HCL 1MG TAB	$23.89	FSS	AvKare, LLC	06/14/2028

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

API Supply Chain8 active DMFs1 inactive

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

MEDICHEM SAGUANFACINE HYDROCHLORIDE

DMF 85901990

QUIMICA SINTETICA SAGUANFACINE HYDROCHLORIDE

DMF 86611990

JUBILANT PHARMOVA LTDGUANFACINE HYDROCHLORIDE USP

DMF 280492014

PROCOS SPAGUANFACINE HYDROCHLORIDE

DMF 283122014

TORRENT PHARMACEUTICALS LTDGUANFACINE HYDROCHLORIDE USP

DMF 284432014

UNICHEM LABORATORIES LTDGUANFACINE HYDROCHLORIDE USP

DMF 346532020

PHARMABLOCK PHARMACEUTICALS (ZHEJIANG) CO LTDGUANFACINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE

DMF 364312021

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTDGUANFACINE HYDROCHLORIDE

DMF 394042024

SANDOZ PHARMACEUTICALS CORP DIV SANDOZ INCInactiveGUANFACINE HYDROCHLORIDE

DMF 49851983

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 26, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 1MG BASE

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 5, 2012

No patent or exclusivity listings for this strength.

#002 — EQ 2MG BASE

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 5, 2012

#003 — EQ 3MG BASE

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 5, 2012

#004 — EQ 4MG BASE

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 5, 2012