Sucralfate

Product NDC: 66689-305
11-digit product format: 666890305
Labeler code: 66689
Product ID: 66689-305_d88c8a64-33d7-4977-9371-2d51c2700589
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sucralfate
Dosage form: SUSPENSION
Route: ORAL
Labeler: VistaPharm, LLC
Application: ANDA211884
Marketing category: ANDA
Marketing start: 2022-03-15
Substance: SUCRALFATE
Active strength: 1 g/10mL
Pharmacologic classes: Aluminum Complex [EPC], Organometallic Compounds [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
2026-10-15 13:18:30	2026-09	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	RS	2022-03-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	RS	2022-03-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211884-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	RS	2022-03-15	`caaa826d4ba7…`
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
2026-10-15 13:18:30	2026-09	A211884-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A211884-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211884-001	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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/10mL

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
313123	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
cbfbe146-5d42-4a55-9050-df2b5581487a	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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66689-305-16	Sucralfate	414 mL in 1 BOTTLE, PLASTIC	SUSPENSION	414		7
66689-305-16	Sucralfate	1 in 1 CARTON	SUSPENSION	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66689-305-16	ML - Milliliter	66689-305	bbe80148-82ef-43e6-bb2b-4e311902dee1	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66689-305	SUCRALFATE SUSPENSION [VISTAPHARM, LLC]	7	Current NDC, Legacy NDC, 2 package rows	20231219_cbfbe146-5d42-4a55-9050-df2b5581487a.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sucralfate	SUCRALFATE	VistaPharm, LLC	cbfbe146-5d42-4a55-9050-df2b5581487a	2026-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211884 application number: ANDA211884 ndc (product): 66689-305
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	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313123	sucralfate 1 GM in 10 mL Oral Suspension	PSN	cbfbe146-5d42-4a55-9050-df2b5581487a	7
313123	sucralfate 100 MG/ML Oral Suspension	SCD	cbfbe146-5d42-4a55-9050-df2b5581487a	7
313123	sucralfate 1 GM per 10 ML Oral Suspension	SY	cbfbe146-5d42-4a55-9050-df2b5581487a	7
313123	sucralfate 1 GM in 10 mL Oral Suspension	PSN	e4761fb2-6a1a-44de-9d27-f6addabc24c8	3
313123	sucralfate 1 GM in 10 mL Oral Suspension	PSN	e5073597-ac51-4e7c-a9dc-7695773a01f1	3
313123	sucralfate 100 MG/ML Oral Suspension	SCD	e4761fb2-6a1a-44de-9d27-f6addabc24c8	3
313123	sucralfate 100 MG/ML Oral Suspension	SCD	e5073597-ac51-4e7c-a9dc-7695773a01f1	3
313123	sucralfate 1 GM per 10 ML Oral Suspension	SY	e4761fb2-6a1a-44de-9d27-f6addabc24c8	3
313123	sucralfate 1 GM per 10 ML Oral Suspension	SY	e5073597-ac51-4e7c-a9dc-7695773a01f1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
66689-305-16	66689030516	1 BOTTLE, PLASTIC in 1 CARTON (66689-305-16) / 414 mL in 1 BOTTLE, PLASTIC	2022-03-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sucralfate Oral Suspension	VistaPharm, LLC	2026-09-02	HUMAN PRESCRIPTION DRUG LABEL	9
SUCRALFATE- sucralfate suspension MAJOR® PHARMACEUTICALS	Major Pharmaceuticals	2025-07-21	HUMAN PRESCRIPTION DRUG LABEL	6
Sucralfate Oral Suspension	ATLANTIC BIOLOGICALS CORP.	2025-05-27	HUMAN PRESCRIPTION DRUG LABEL	3
Sucralfate Oral Suspension	McKesson Corporation dba SKY Packaging	2024-12-12	HUMAN PRESCRIPTION DRUG LABEL	4
Sucralfate Oral Suspension Rx Only I0974C0223 R02/23	American Health Packaging	2023-08-10	HUMAN PRESCRIPTION DRUG LABEL	3