NDC 68084-083-11 - Isosorbide Dinitrate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 68084-083
Requested NDC: 68084-083-11
Package NDCs from labels: 68084-083-11, 68084-083-01
Manufacturer: American Health Packaging
Effective date: 2025-10-15
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Isosorbide Dinitrate - American Health Packaging	American Health Packaging	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68084-083-01	Isosorbide Dinitrate	100 in 1 BOX, UNIT-DOSE	TABLET	100		10
68084-083-11	Isosorbide Dinitrate	1 in 1 BLISTER PACK	TABLET	1		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-083	ISOSORBIDE DINITRATE TABLET [AMERICAN HEALTH PACKAGING]	9	Current NDC, Legacy NDC, 2 package rows	20241215_5c94ecc0-fcaa-4af3-82c2-ff124f2df3e1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-083-01	EA - Each	68084-083	f3927b66-4637-4b21-ae4e-c0b69709286b	1	2013-11-04
68084-083-11	EA - Each	68084-083	9bca44fb-0a35-4759-94ae-47aec1e11ce8	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ISOSORBIDE DINITRATE	ACTIVE INGREDIENT	IA7306519N	ISOSORBIDE DINITRATE TABLET [AMERICAN HEALTH PACKAGING]	1
ISOSORBIDE DINITRATE	ACTIVE MOIETY	IA7306519N	ISOSORBIDE DINITRATE TABLET [AMERICAN HEALTH PACKAGING]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ISOSORBIDE DINITRATE TABLET [AMERICAN HEALTH PACKAGING]	1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Par Health USA, LLC	6df6a2fa-c56c-4eb6-a485-c16585420eb0	2026-07-31	Warnings, Adverse reactions	Exact identifier application number: ANDA086925 application number: ANDA087537 ndc (product): 49884-022 ndc (product): 49884-021 rxcui: 197839 rxcui: 314055 rxcui: 381056 rxcui: 206842 spl id: 90d3efd1-9d17-4bee-967d-30d2d7ba597c spl set id: 6df6a2fa-c56c-4eb6-a485-c16585420eb0 unii: IA7306519N
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Par Health USA, LLC	3d6164d7-3083-41c5-a6a6-7e144fe29f7d	2026-07-22	Warnings, Adverse reactions	Exact identifier unii: IA7306519N
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Cardinal Health 107, LLC	5f585259-59ed-4648-b562-164f3746c821	2026-05-19	Warnings, Adverse reactions	Exact identifier rxcui: 381056 rxcui: 206842 unii: IA7306519N
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Major Pharmaceuticals	6c4997e7-9ce6-46a6-a9c1-4bd3d76155eb	2026-03-13	Warnings, Adverse reactions	Exact identifier rxcui: 381056 rxcui: 206842 unii: IA7306519N
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	AvPAK	0e5842f2-74f6-1f02-01bc-07578bd3b393	2026-02-10	Warnings, Adverse reactions	Exact identifier application number: ANDA086925 application number: ANDA087537 rxcui: 314055 rxcui: 381056 rxcui: 206842 unii: IA7306519N
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	REMEDYREPACK INC.	829ed058-333f-453c-9f0e-9202e03acf97	2026-01-08	Warnings, Adverse reactions	Exact identifier rxcui: 381056 unii: IA7306519N
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Golden State Medical Supply, Inc.	7f860fbd-f130-4652-e053-2991aa0a402e	2026-01-08	Warnings, Adverse reactions	Exact identifier rxcui: 314055 rxcui: 381056 rxcui: 206842 unii: IA7306519N
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	Advagen Pharma Ltd	b166eb5b-bad8-4663-9c05-1c43539dab2c	2026-01-05	Warnings, Adverse reactions	Exact identifier rxcui: 197839 rxcui: 314055 rxcui: 381056 rxcui: 206842 unii: IA7306519N
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Hikma Pharmaceuticals USA Inc.	f0b9b320-0bf8-4342-b654-135ccb6755c2	2025-12-05	Warnings, Adverse reactions	Exact identifier rxcui: 314055 rxcui: 381056 rxcui: 206842 unii: IA7306519N
BiDil	HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE	Azurity Pharmaceuticals, Inc.	e1e63cd5-d1e4-4af5-bad5-1ad41ea46b00	2025-11-30	Warnings, Adverse reactions	Exact identifier unii: IA7306519N
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	American Health Packaging	5c94ecc0-fcaa-4af3-82c2-ff124f2df3e1	2025-10-15	Warnings, Adverse reactions	Exact identifier application number: ANDA086925 application number: ANDA087537 ndc (package): 68084-083-01 ndc (package): 68084-082-11 ndc (package): 68084-083-11 ndc (package): 68084-082-01 ndc (product): 68084-082 ndc (product): 68084-083 ndc11 (package): 68084008311 rxcui: 381056 rxcui: 206842 spl id: 4133d711-2ce0-0891-e063-6294a90aeaab spl set id: 5c94ecc0-fcaa-4af3-82c2-ff124f2df3e1 unii: IA7306519N
Isosorbide dinitrate	ISOSORBIDE DINITRATE	Northstar Rx LLC	246c749d-aa28-44ce-8d42-984660afff2a	2025-08-21	Warnings, Adverse reactions	Exact identifier rxcui: 197839 rxcui: 314055 rxcui: 381056 rxcui: 206842 unii: IA7306519N
Isosorbide dinitrate and hydralazine hydrochloride	ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	Ingenus Pharmaceuticals, LLC	8f54d5a3-169f-48dd-9250-2c176d2bd9ad	2025-06-03	Warnings, Adverse reactions	Exact identifier unii: IA7306519N
YVTYVT MICRODERMABRASION FACIAL SCRUB	YVTYVT MICRODERMABRASION FACIAL SCRUB	Beijing JUNGE Technology Co., Ltd.	2f30fc45-42e2-c766-e063-6394a90a8d68	2025-02-28	Warnings	Exact identifier unii: OP1R32D61U
isosorbide dinitrate and hydralazine hydrochloride	ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	A2A Integrated Pharmaceuticals	ae757a78-89e8-4f79-81de-d558db3f72a4	2025-02-28	Warnings, Adverse reactions	Exact identifier unii: IA7306519N
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Bryant Ranch Prepack	73a1e6c0-71d0-4ba1-bbca-c067479e487d	2024-10-08	Warnings, Adverse reactions	Exact identifier unii: IA7306519N
Isosorbide dinitrate	ISOSORBIDE DINITRATE	BluePoint Laboratories	f1d52e9a-8de1-61db-e053-2a95a90aae50	2024-09-17	Warnings, Adverse reactions	Exact identifier rxcui: 197839 unii: IA7306519N
Isosorbide dinitrate	ISOSORBIDE DINITRATE	Zydus Pharmaceuticals (USA) Inc.	16818b32-ee5e-4e07-b848-31e892c4b98a	2024-08-08	Warnings, Adverse reactions	Exact identifier rxcui: 197839 rxcui: 314055 rxcui: 381056 rxcui: 206842 unii: IA7306519N
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	Proficient Rx LP	1cf9b6dd-9d4e-4ea1-95ae-e9e46a3d1b20	2024-08-01	Warnings, Adverse reactions	Exact identifier rxcui: 206842 unii: IA7306519N
isosorbide dinitrate and hydralazine hydrochloride	HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE	Bryant Ranch Prepack	2a6fe05a-fcd4-42d1-bf5d-1d39ac273363	2024-07-01	Warnings, Adverse reactions	Exact identifier unii: IA7306519N

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.