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ISOSORBIDE MONONITRATE

ANDA

ISOSORBIDE MONONITRATE | A075037 | GENUS LIFESCIENCES INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: MONOKET(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 2 NDCs

Highest NADAC/Unit

$2.65

per ea

Lowest NADAC/Unit

$2.38

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00228263111ISOSORBIDE MONONIT 10 MG TAB	$2.65	EA	Generic	—	2026-08-19
00228262011ISOSORBIDE MONONIT 20 MG TAB	$2.38	EA	Generic	—	2026-08-19

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

API Supply Chain0 active DMFs1 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SHANDONG NEW TIME PHARMACEUTICAL CO LTDInactiveISOSORBIDE MONONITRATE (NON-STERILE, BULK FORM)

DMF 208162007

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 30, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 20MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 30, 1998

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 30, 1998