Sucralfate

Product NDC: 80425-0091
11-digit product format: 804250091
Labeler code: 80425
Product ID: 80425-0091_2a994dc6-72f5-0559-e063-6394a90a0ecf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sucralfate
Dosage form: TABLET
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA070848
Marketing category: ANDA
Marketing start: 1996-11-11
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
A070848-001	SUCRALFATE	SUCRALFATE	1GM	TABLET / ORAL	AB		1996-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070848-001	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	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`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	A070848-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070848-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070848-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070848-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070848-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070848-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070848-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070848-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070848-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070848-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070848-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070848-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070848-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070848-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070848-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070848-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070848-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070848-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070848-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070848-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070848-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070848-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070848-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070848-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070848-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070848-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070848-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070848-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070848-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070848-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070848-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070848-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070848-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070848-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070848-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070848-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070848-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070848-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070848-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070848-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sucralfate
Listing expiration: 2026-12-31

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
b39f22c8-f224-451a-e053-2995a90aaad7	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	Strength	SPL version
80425-0091-1	Sucralfate	30 in 1 BOTTLE	TABLET	30		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0091-1	EA - Each	80425-0091	187cb544-ae9f-4e7a-b21a-eb980ad159f4	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0091	SUCRALFATE TABLET [ADVANCED RX OF TENNESSEE, LLC]	5	Current NDC, Legacy NDC, 1 package rows	20250101_b39f22c8-f224-451a-e053-2995a90aaad7.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sucralfate	SUCRALFATE	Cardinal Health 107, LLC	444a743a-4843-4b33-bad5-3dfc1fb2d004	2026-07-29	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848
Sucralfate	SUCRALFATE	Cardinal Health 107, LLC	1eb38f64-4d5a-46e6-a030-057beece5e44	2026-07-10	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848
Sucralfate	SUCRALFATE	ASCLEMED USA INC.	cd25eb96-29ea-48b2-bdee-c2ea98f216b8	2026-05-18	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848
Sucralfate	SUCRALFATE	Safecor Health LLC	1a6d96f2-fe1f-4aaf-8520-616973c224aa	2026-04-07	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848
Sucralfate	SUCRALFATE	Northwind Health Company, LLC	464bf611-4dbb-4707-b9dd-39ca178ed4bf	2025-12-26	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848
Sucralfate	SUCRALFATE	Preferred Pharmaceuticals Inc.	5ec71444-cc55-47bd-8abc-b3cfc3b47d8e	2025-09-24	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848
Sucralfate	SUCRALFATE	Mylan Institutional Inc.	989ca8a8-3ad6-4ee4-aa9c-eed731828753	2025-07-22	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848
Sucralfate	SUCRALFATE	NCS HealthCare of KY, LLC dba Vangard Labs	d67dcaad-56c1-4e77-a0c8-655970808414	2025-06-13	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848
SUCRALFATE	SUCRALFATE	DIRECT RX	c50b5044-31ed-672a-e053-2995a90a49fc	2025-01-20	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848
Sucralfate	SUCRALFATE	Advanced Rx of Tennessee, LLC	b39f22c8-f224-451a-e053-2995a90aaad7	2024-12-31	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848 ndc (product): 80425-0091
Sucralfate	SUCRALFATE	NuCare Pharmaceuticals,Inc.	a40e43d4-9240-34ad-e053-2995a90a98e1	2024-07-15	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848
Sucralfate	SUCRALFATE	Proficient Rx LP	a42c5f3d-85f1-485b-91e6-58c25b3ddc71	2024-01-01	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848
Sucralfate	SUCRALFATE	Bryant Ranch Prepack	2687d670-8af6-42a2-9081-fee112e80fc0	2023-05-24	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848
Sucralfate	SUCRALFATE	Teva Pharmaceuticals USA, Inc.	c7a43df7-eb37-4273-9250-87953b1fd270	2015-09-01	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848

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	b39f22c8-f224-451a-e053-2995a90aaad7	5
314234	sucralfate 1000 MG Oral Tablet	SCD	b39f22c8-f224-451a-e053-2995a90aaad7	5
314234	sucralfate 1 GM Oral Tablet	SY	b39f22c8-f224-451a-e053-2995a90aaad7	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80425-0091-1	80425009101	30 TABLET in 1 BOTTLE (80425-0091-1)	30 tablet	1996-11-11	0000-00-00	No	No	Current