Sucralfate

Product NDC: 50090-0582
11-digit product format: 500900582
Labeler code: 50090
Product ID: 50090-0582_b16feea3-3320-4c26-a901-36e9e450db02
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sucralfate
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA070848
Marketing category: ANDA
Marketing start: 1996-11-11
Marketing end: 0000-00-00
Substance: SUCRALFATE
Active strength: 1 g/1
Pharmacologic classes: Aluminum Complex [EPC],Organometallic Compounds [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50090-0582		D	Discontinued by firm		2026-08-17
excluded package	package	50090-0582	50090-0582-0	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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0582-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0582-0	`f5e01cc5f278…`	`a2eaf40c39c3…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-0582-0	2024-01-11	C162847	48780-1	f386c64a-1c2c-0266-e053-dadaa90a7c1a	SUCRALFATE TABLETS, USP 2210 Rx only
50090-0582-0	2023-01-30	C162847	48780-1	f386c64a-1c2c-0266-e053-dadaa90a7c1a	SUCRALFATE TABLETS, USP 2210 Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0582-0	EA - Each	50090-0582	5c6d4784-c37a-478d-a5ad-ffaedac28479	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0582	SUCRALFATE TABLET [A-S MEDICATION SOLUTIONS]	17	Legacy NDC	20240113_85b9352c-4abb-43d2-b4ca-a03fce4dc4fb.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0582-0	50090058200	60 TABLET in 1 BOTTLE (50090-0582-0)	60 tablet	2014-11-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SUCRALFATE TABLETS, USP 2210 Rx only	A-S Medication Solutions	2024-01-11	HUMAN PRESCRIPTION DRUG LABEL	17