ISOSORBIDE MONONITRATE

Product NDC: 13668-104
11-digit product format: 136680104
Labeler code: 13668
Product ID: 13668-104_34e0adcc-8899-4abb-bba4-6be95d0ce2dd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ISOSORBIDE MONONITRATE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA200270
Marketing category: ANDA
Marketing start: 2011-06-03
Substance: ISOSORBIDE MONONITRATE
Active strength: 30 mg/1
Pharmacologic classes: Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A200270-001	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-06-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A200270-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200270-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A200270-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200270-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200270-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200270-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200270-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200270-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200270-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200270-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200270-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200270-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200270-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200270-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200270-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200270-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200270-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200270-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200270-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200270-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200270-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200270-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200270-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200270-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200270-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200270-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200270-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200270-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200270-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200270-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200270-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200270-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200270-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200270-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200270-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200270-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200270-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200270-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200270-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200270-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200270-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200270-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: ISOSORBIDE MONONITRATE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ISOSORBIDE MONONITRATE	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LX1OH63030	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311196	Internal RxNorm lookup
317110	Internal RxNorm lookup
353538	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
cc3f7505-fd5d-aab9-1128-173349f98a63	Product name	4	20230113
f23201a1-1f10-4748-0041-3c03fbb37cfb	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
13668-104-01	ISOSORBIDE MONONITRATE	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	13
13668-104-05	ISOSORBIDE MONONITRATE	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	13
13668-104-10	ISOSORBIDE MONONITRATE	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-104-01	EA - Each	13668-104	f8c8b922-604a-45cc-8f2a-3e3bc641ea64	1	2012-07-24
13668-104-05	EA - Each	13668-104	5cdfdfc9-02a5-4831-99fd-41e9b65d4c43	1	2012-07-24
13668-104-10	EA - Each	13668-104	63ae7a43-39ae-4769-a635-1a1ada9e9d54	1	2012-07-24
13668-104-40	EA - Each	13668-104	29c3a993-f77d-40c6-9731-14cd8dca1b81	1	2012-07-24
13668-104-74	EA - Each	13668-104	2369c105-888e-4169-9baa-4d05b305afce	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ISOSORBIDE MONONITRATE	ACTIVE INGREDIENT	LX1OH63030	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	3
ISOSORBIDE MONONITRATE	ACTIVE INGREDIENT	LX1OH63030	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
ISOSORBIDE MONONITRATE	ACTIVE MOIETY	LX1OH63030	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	3
ISOSORBIDE MONONITRATE	ACTIVE MOIETY	LX1OH63030	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	3
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
DIETHYL PHTHALATE	INACTIVE INGREDIENT	UF064M00AF	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	3
DIETHYL PHTHALATE	INACTIVE INGREDIENT	UF064M00AF	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	3
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
HYDROXYPROPYL CELLULOSE (TYPE E)	INACTIVE INGREDIENT	66O7AQV0RT	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13668-104	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	12	Current NDC, Legacy NDC, 3 package rows	20241025_0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c.zip

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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	REMEDYREPACK INC.	d01d4f0f-5164-4ea3-b772-72b97961c6fb	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200270 application number: ANDA200270
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Cardinal Health 107, LLC	72b8a20c-5833-4765-a4b5-9066eaec6ea1	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200270 application number: ANDA200270
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Major Pharmaceuticals	8cbb364a-bafe-454b-a53f-bd7cd69a5593	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200270 application number: ANDA200270
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Torrent Pharmaceuticals Limited	0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200270 application number: ANDA200270 ndc (product): 13668-104
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	American Health Packaging	6a582db5-eb45-4320-98c1-55517d7d8c38	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200270 application number: ANDA200270
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	NCS HealthCare of KY, LLC dba Vangard Labs	63dc518f-4f86-4820-98c2-5de8aed09a4b	2024-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200270 application number: ANDA200270

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LX1OH63030	ISOSORBIDE MONONITRATE	16051-77-7	ISOSORBIDE MONONITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311196	isosorbide mononitrate 120 MG 24HR Extended Release Oral Tablet	PSN	0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c	13
317110	isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet	PSN	0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c	13
353538	isosorbide mononitrate 60 MG 24HR Extended Release Oral Tablet	PSN	0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c	13
311196	24 HR isosorbide mononitrate 120 MG Extended Release Oral Tablet	SCD	0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c	13
317110	24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet	SCD	0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c	13
353538	24 HR isosorbide mononitrate 60 MG Extended Release Oral Tablet	SCD	0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c	13
311196	isosorbide mononitrate 120 MG 24 HR Extended Release Oral Tablet	SY	0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c	13
317110	isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet	SY	0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c	13
353538	isosorbide mononitrate 60 MG 24 HR Extended Release Oral Tablet	SY	0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c	13
317110	isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet	PSN	d01d4f0f-5164-4ea3-b772-72b97961c6fb	8
317110	isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet	PSN	8cbb364a-bafe-454b-a53f-bd7cd69a5593	8
353538	isosorbide mononitrate 60 MG 24HR Extended Release Oral Tablet	PSN	8cbb364a-bafe-454b-a53f-bd7cd69a5593	8
317110	24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet	SCD	d01d4f0f-5164-4ea3-b772-72b97961c6fb	8
317110	24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet	SCD	8cbb364a-bafe-454b-a53f-bd7cd69a5593	8
353538	24 HR isosorbide mononitrate 60 MG Extended Release Oral Tablet	SCD	8cbb364a-bafe-454b-a53f-bd7cd69a5593	8
317110	isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet	SY	d01d4f0f-5164-4ea3-b772-72b97961c6fb	8
317110	isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet	SY	8cbb364a-bafe-454b-a53f-bd7cd69a5593	8
353538	isosorbide mononitrate 60 MG 24 HR Extended Release Oral Tablet	SY	8cbb364a-bafe-454b-a53f-bd7cd69a5593	8
317110	isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet	PSN	63dc518f-4f86-4820-98c2-5de8aed09a4b	5
317110	24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet	SCD	63dc518f-4f86-4820-98c2-5de8aed09a4b	5
317110	isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet	SY	63dc518f-4f86-4820-98c2-5de8aed09a4b	5
317110	isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet	PSN	6a582db5-eb45-4320-98c1-55517d7d8c38	4
353538	isosorbide mononitrate 60 MG 24HR Extended Release Oral Tablet	PSN	6a582db5-eb45-4320-98c1-55517d7d8c38	4
317110	24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet	SCD	6a582db5-eb45-4320-98c1-55517d7d8c38	4
353538	24 HR isosorbide mononitrate 60 MG Extended Release Oral Tablet	SCD	6a582db5-eb45-4320-98c1-55517d7d8c38	4
317110	isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet	SY	6a582db5-eb45-4320-98c1-55517d7d8c38	4
353538	isosorbide mononitrate 60 MG 24 HR Extended Release Oral Tablet	SY	6a582db5-eb45-4320-98c1-55517d7d8c38	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-104-01	13668010401	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-104-01)	2011-06-03	0000-00-00	No	No	Current
13668-104-05	13668010405	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-104-05)	2024-08-23	0000-00-00	No	No	Current
13668-104-10	13668010410	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-104-10)	2011-06-03	0000-00-00	No	No	Current
13668-104-40	13668010440	4000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-104-40)	2011-06-03	0000-00-00	No	No	Current
13668-104-74	13668010474	100 TABLET, EXTENDED RELEASE in 1 CARTON (13668-104-74)	2011-06-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isosorbide Mononitrate Extended-Release Tablets, USP Rx only	REMEDYREPACK INC.	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL	9
Isosorbide Mononitrate Extended-Release Tablets, USP Rx only	Major Pharmaceuticals	2026-05-27	HUMAN PRESCRIPTION DRUG LABEL	9
Isosorbide Mononitrate Extended-Release Tablets, USP Rx only	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc.	2026-05-11	HUMAN PRESCRIPTION DRUG LABEL	13
Isosorbide Mononitrate Extended-Release Tablets, USP 8479401/0825 Rx only	American Health Packaging	2025-10-01	HUMAN PRESCRIPTION DRUG LABEL	4
Isosorbide Mononitrate Extended-Release Tablets, USP Rx only	NCS HealthCare of KY, LLC dba Vangard Labs \| Torrent Pharmaceuticals Limited	2024-08-13	HUMAN PRESCRIPTION DRUG LABEL	5
Isosorbide Mononitrate Extended-Release Tablets, USP	NuCarePharmaceuticals, Inc. \| NuCare Pharmaceuticals, Inc.	2020-05-05	HUMAN PRESCRIPTION DRUG LABEL	2
Isosorbide Mononitrate ER	Direct Rx \| Direct_Rx	2019-01-04	HUMAN PRESCRIPTION DRUG LABEL	1
Isosorbide Mononitrate Extended-Release Tablets, USP	A-S Medication Solutions	2017-10-26	HUMAN PRESCRIPTION DRUG LABEL	6