Sucralfate

Product NDC: 0904-7269
Requested package NDC: 0904-7269-18
11-digit product format: 009047269
Labeler code: 0904
Product ID: 0904-7269_ec83e1ee-e504-0759-e053-2995a90a22a5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sucralfate
Dosage form: SUSPENSION
Route: ORAL
Labeler: MAJOR
Application: ANDA211884
Marketing category: ANDA
Marketing start: 2022-03-15
Marketing end: 0000-00-00
Substance: SUCRALFATE
Active strength: 1 g/10mL
Pharmacologic classes: Aluminum Complex [EPC], Organometallic Compounds [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0904-7269	0904-7269-18	D	Discontinued by firm		2026-08-07

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0904-7269	0904-7269-18	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A211884-001	SUCRALFATE	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	RS	2022-03-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211884-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2022-03-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	RS	2022-03-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211884-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211884-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211884-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211884-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211884-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211884-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211884-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211884-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211884-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211884-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211884-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211884-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211884-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211884-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211884-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211884-001	AB	1	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211884-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211884-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211884-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211884-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211884-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211884-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211884-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211884-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211884-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211884-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211884-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211884-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211884-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211884-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211884-001	CGT	2022-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211884-001	CGT	2022-09-11	`5d02ea3f76ae…`
2023-01-26 05:58 UTC	2023-01	A211884-001	CGT	2022-09-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211884-001	CGT	2022-09-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211884-001	CGT	2022-09-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211884-001	CGT	2022-09-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211884-001	CGT	2022-09-11	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7269-18	ML - Milliliter	0904-7269	9c15bffc-5b85-47a5-b8ec-ad6f10c33ead	1	2022-12-07
0904-7269-66	ML - Milliliter	0904-7269	5d2efa09-ff9e-46e0-b655-998f1541453c	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7269	SUCRALFATE SUSPENSION [MAJOR PHARMACEUTICALS]	5	Legacy NDC	20240126_ec83e1ee-e503-0759-e053-2995a90a22a5.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
Sucralfate	SUCRALFATE	Cardinal Health 107, LLC	92c8672a-c6b8-4ec8-a815-c30bdd960ac7	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211884 application number: ANDA211884
Sucralfate	SUCRALFATE	PAI Holdings, LLC dba PAI Pharma	113a068a-2ce9-421c-8b89-87ce30e19225	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211884 application number: ANDA211884
Sucralfate	SUCRALFATE ORAL SUSPENSION	Major Pharmaceuticals	98a8fedd-fa06-416a-8a85-b899631978f9	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211884 application number: ANDA211884
Sucralfate	SUCRALFATE	ATLANTIC BIOLOGICALS CORP.	e5073597-ac51-4e7c-a9dc-7695773a01f1	2025-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211884 application number: ANDA211884
Sucralfate	SUCRALFATE	VistaPharm, LLC	cbfbe146-5d42-4a55-9050-df2b5581487a	2023-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211884 application number: ANDA211884
Sucralfate	SUCRALFATE	American Health Packaging	e4761fb2-6a1a-44de-9d27-f6addabc24c8	2023-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211884 application number: ANDA211884

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
0904-7269-18	00904726918	4 TRAY in 1 CASE (0904-7269-18) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (0904-7269-66)	4 tray	2022-11-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SUCRALFATE- sucralfate suspension MAJOR® PHARMACEUTICALS	Major Pharmaceuticals	2025-07-21	HUMAN PRESCRIPTION DRUG LABEL	6