ISOSORBIDE MONONITRATE

Product NDC: 70518-2956
Requested package NDC: 70518-2956-0
11-digit product format: 705182956
Labeler code: 70518
Product ID: 70518-2956_4ab9f8a1-dca0-d354-e063-6394a90ae775
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ISOSORBIDE MONONITRATE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA200270
Marketing category: ANDA
Marketing start: 2020-12-03
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-2956	70518-2956-0	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
317110	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
d01d4f0f-5164-4ea3-b772-72b97961c6fb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cc3f7505-fd5d-aab9-1128-173349f98a63	Product name	4	20230113
f23201a1-1f10-4748-0041-3c03fbb37cfb	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2022-02-10	Isosorbide Mononitrate Extended-Release Tablets, USP Rx only
2022-02-10	Isosorbide Mononitrate Extended-Release Tablets, USP Rx only
2022-01-28	Isosorbide Mononitrate Extended-Release Tablets, USP Rx only
2022-01-28	Isosorbide Mononitrate Extended-Release Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-2956-0	ISOSORBIDE MONONITRATE	30 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	30		8
70518-2956-1	ISOSORBIDE MONONITRATE	30 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	30		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-2956	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]	6	Current NDC, Legacy NDC, 2 package rows	20250406_d01d4f0f-5164-4ea3-b772-72b97961c6fb.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 ndc (package): 70518-2956-0 ndc (product): 70518-2956 ndc11 (package): 70518295600
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
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
317110	isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet	PSN	d01d4f0f-5164-4ea3-b772-72b97961c6fb	8
317110	24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet	SCD	d01d4f0f-5164-4ea3-b772-72b97961c6fb	8
317110	isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet	SY	d01d4f0f-5164-4ea3-b772-72b97961c6fb	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2956-0	70518295600	30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-2956-0)	2020-12-03	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