Sucralfate

Product NDC: 72578-081
11-digit product format: 725780081
Labeler code: 72578
Product ID: 72578-081_a60d75d8-56a3-489e-9806-3b2f9fb6d553
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sucralfate
Dosage form: TABLET
Route: ORAL
Labeler: Viona Pharmaceuticals Inc
Application: ANDA215705
Marketing category: ANDA
Marketing start: 2023-05-20
Substance: SUCRALFATE
Active strength: 1 g/1
Pharmacologic classes: Aluminum Complex [EPC], Organometallic Compounds [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
A215705-001	SUCRALFATE	SUCRALFATE	1GM	TABLET / ORAL	AB		2023-05-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215705-001	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.

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	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A215705-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215705-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215705-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215705-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215705-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215705-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215705-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215705-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215705-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215705-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215705-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215705-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215705-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215705-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215705-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215705-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215705-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215705-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215705-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215705-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215705-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215705-001	AB	1	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215705-001	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SUCRALFATE	1 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
XX73205DH5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
314234	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
c708201b-2618-4470-a3ff-8ecf04d6b3a0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
01e96ee1-fe82-0132-025c-ec1559bf8b6e	Product name	5	20260127
f9fa5fa8-e047-2182-3e2c-c4a9ec6531cd	Product name	3	20240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72578-081-01	Sucralfate	100 in 1 BOTTLE	TABLET	100	2
72578-081-05	Sucralfate	500 in 1 BOTTLE	TABLET	500	2
72578-081-06	Sucralfate	30 in 1 BOTTLE	TABLET	30	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72578-081-01	EA - Each	72578-081	80461b41-7ef1-4683-b450-7e9dd9adb5c0	1	2023-06-06
72578-081-05	EA - Each	72578-081	f2e5d26b-6d09-4618-9d7f-b5d2dd88a434	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72578-081	SUCRALFATE TABLET [VIONA PHARMACEUTICALS INC]	2	Current NDC, 3 package rows	20240310_c708201b-2618-4470-a3ff-8ecf04d6b3a0.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sucralfate	SUCRALFATE	Zydus Lifesciences Limited	882b7596-f62c-4be2-8f67-e64310718baa	2026-08-08	Adverse reactions	Exact identifier application applno (ANDA): 215705 application number: ANDA215705
Sucralfate	SUCRALFATE	Viona Pharmaceuticals Inc	c708201b-2618-4470-a3ff-8ecf04d6b3a0	2026-08-08	Adverse reactions	Exact identifier application applno (ANDA): 215705 application number: ANDA215705 ndc (product): 72578-081
Sucralfate	SUCRALFATE	NCS HealthCare of KY, LLC dba Vangard Labs	3b0259fa-806f-44c1-8deb-c11dbd84582d	2026-06-24	Adverse reactions	Exact identifier application applno (ANDA): 215705 application number: ANDA215705
Sucralfate	SUCRALFATE	Preferred Pharmaceuticals Inc	a434bf8f-cc60-4d84-a9a4-61c3ff6b700e	2026-01-21	Adverse reactions	Exact identifier application applno (ANDA): 215705 application number: ANDA215705
Sucralfate	SUCRALFATE	Redpharm Drug	3251e156-4c52-63b3-e063-6294a90a9a95	2025-12-18	Adverse reactions	Exact identifier application applno (ANDA): 215705 application number: ANDA215705
Sucralfate	SUCRALFATE	NuCare Pharmaceuticals, Inc.	31a7dcd0-e677-249a-e063-6294a90a75f6	2025-03-19	Adverse reactions	Exact identifier application applno (ANDA): 215705 application number: ANDA215705
Sucralfate	SUCRALFATE	Coupler LLC	2d586736-73ae-9af0-e063-6294a90ad875	2025-02-04	Adverse reactions	Exact identifier application applno (ANDA): 215705 application number: ANDA215705
Sucralfate	SUCRALFATE	Bryant Ranch Prepack	a068e818-8da3-4f0d-88e0-acc88e76f3aa	2024-08-22	Adverse reactions	Exact identifier application applno (ANDA): 215705 application number: ANDA215705

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XX73205DH5	SUCRALFATE	54182-58-0	SUCRALFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314234	sucralfate 1 GM Oral Tablet	PSN	3251e156-4c52-63b3-e063-6294a90a9a95	4
314234	sucralfate 1 GM Oral Tablet	PSN	c0ee24dd-de9c-4d24-b8d8-c45b02752c1c	4
314234	sucralfate 1000 MG Oral Tablet	SCD	3251e156-4c52-63b3-e063-6294a90a9a95	4
314234	sucralfate 1000 MG Oral Tablet	SCD	c0ee24dd-de9c-4d24-b8d8-c45b02752c1c	4
314234	sucralfate 1 GM Oral Tablet	SY	3251e156-4c52-63b3-e063-6294a90a9a95	4
314234	sucralfate 1 GM Oral Tablet	SY	c0ee24dd-de9c-4d24-b8d8-c45b02752c1c	4
314234	sucralfate 1 GM Oral Tablet	PSN	c708201b-2618-4470-a3ff-8ecf04d6b3a0	2
314234	sucralfate 1 GM Oral Tablet	PSN	a434bf8f-cc60-4d84-a9a4-61c3ff6b700e	2
314234	sucralfate 1000 MG Oral Tablet	SCD	c708201b-2618-4470-a3ff-8ecf04d6b3a0	2
314234	sucralfate 1000 MG Oral Tablet	SCD	a434bf8f-cc60-4d84-a9a4-61c3ff6b700e	2
314234	sucralfate 1 GM Oral Tablet	SY	c708201b-2618-4470-a3ff-8ecf04d6b3a0	2
314234	sucralfate 1 GM Oral Tablet	SY	a434bf8f-cc60-4d84-a9a4-61c3ff6b700e	2
314234	sucralfate 1 GM Oral Tablet	PSN	2d586736-73ae-9af0-e063-6294a90ad875	1
314234	sucralfate 1 GM Oral Tablet	PSN	31a7dcd0-e677-249a-e063-6294a90a75f6	1
314234	sucralfate 1 GM Oral Tablet	PSN	a068e818-8da3-4f0d-88e0-acc88e76f3aa	1
314234	sucralfate 1000 MG Oral Tablet	SCD	a068e818-8da3-4f0d-88e0-acc88e76f3aa	1
314234	sucralfate 1000 MG Oral Tablet	SCD	31a7dcd0-e677-249a-e063-6294a90a75f6	1
314234	sucralfate 1000 MG Oral Tablet	SCD	2d586736-73ae-9af0-e063-6294a90ad875	1
314234	sucralfate 1 GM Oral Tablet	SY	a068e818-8da3-4f0d-88e0-acc88e76f3aa	1
314234	sucralfate 1 GM Oral Tablet	SY	2d586736-73ae-9af0-e063-6294a90ad875	1
314234	sucralfate 1 GM Oral Tablet	SY	31a7dcd0-e677-249a-e063-6294a90a75f6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72578-081-01	72578008101	100 TABLET in 1 BOTTLE (72578-081-01)	100 tablet	2023-05-20	No	No	Current
72578-081-05	72578008105	500 TABLET in 1 BOTTLE (72578-081-05)	500 tablet	2023-05-20	No	No	Current
72578-081-06	72578008106	30 TABLET in 1 BOTTLE (72578-081-06)	30 tablet	2023-05-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sucralfate Tablets USP, 1g	Viona Pharmaceuticals Inc \| Zydus Lifesciences Limited	2026-08-08	HUMAN PRESCRIPTION DRUG LABEL	3
Sucralfate Tablets USP, 1g	NCS HealthCare of KY, LLC dba Vangard Labs \| Zydus Lifesciences Limited	2026-06-24	HUMAN PRESCRIPTION DRUG LABEL	1
Sucralfate Tablets USP, 1g	REMEDYREPACK INC.	2026-06-11	HUMAN PRESCRIPTION DRUG LABEL	5
Sucralfate Tablets USP, 1g	Preferred Pharmaceuticals Inc	2026-01-21	HUMAN PRESCRIPTION DRUG LABEL	2
Sucralfate Tablets USP, 1g	Redpharm Drug	2025-12-18	HUMAN PRESCRIPTION DRUG LABEL	4
Sucralfate Tablets USP, 1g	NuCare Pharmaceuticals, Inc.	2025-03-19	HUMAN PRESCRIPTION DRUG LABEL	1
Sucralfate Tablets USP, 1g	Coupler LLC \| Zydus Lifesciences Limited	2025-02-04	HUMAN PRESCRIPTION DRUG LABEL	1
Sucralfate Tablets USP, 1g	Bryant Ranch Prepack	2024-08-22	HUMAN PRESCRIPTION DRUG LABEL	1