Sucralfate

Product NDC: 66689-790
Requested package NDC: 66689-790-99
11-digit product format: 666890790
Labeler code: 66689
Product ID: 66689-790_96c64254-3e59-48a9-871a-8db57ede6a29
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sucralfate
Dosage form: SUSPENSION
Route: ORAL
Labeler: VistaPharm, Inc.
Application: NDA019183
Marketing category: NDA
Marketing start: 2012-08-16
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	66689-790	66689-790-99	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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N019183-001	CARAFATE	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL		RLD	1993-12-16

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL		RLD	1993-12-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL		RLD, RS	1993-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL		RLD, RS	1993-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL		RLD, RS	1993-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`e64feba35796…`

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	N019183-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019183-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019183-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019183-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019183-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019183-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019183-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019183-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019183-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019183-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019183-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019183-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019183-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019183-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019183-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019183-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019183-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N019183-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019183-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019183-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019183-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019183-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019183-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019183-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019183-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019183-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019183-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019183-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019183-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019183-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019183-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019183-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019183-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019183-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019183-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019183-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019183-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66689-790-01	ML - Milliliter	66689-790	8aaaf07c-3f03-408a-a5e0-76c68da7edc1	1	2013-02-13
66689-790-40	ML - Milliliter	66689-790	68888f93-4247-4f4a-abc9-cbf5348dfd97	1	2021-08-05
66689-790-50	ML - Milliliter	66689-790	150adfc5-acdd-48b9-afb3-8ff277437e6a	1	2013-02-13
66689-790-99	ML - Milliliter	66689-790	845bd884-d1a5-4168-8b9b-6cf60a69a862	1	2020-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Sucralfate	ACTIVE INGREDIENT	XX73205DH5	SUCRALFATE SUSPENSION [VISTAPHARM, INC.]	1
Sucralfate	ACTIVE MOIETY	XX73205DH5	SUCRALFATE SUSPENSION [VISTAPHARM, INC.]	1
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	SUCRALFATE SUSPENSION [VISTAPHARM, INC.]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	SUCRALFATE SUSPENSION [VISTAPHARM, INC.]	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	SUCRALFATE SUSPENSION [VISTAPHARM, INC.]	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	SUCRALFATE SUSPENSION [VISTAPHARM, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	SUCRALFATE SUSPENSION [VISTAPHARM, INC.]	1

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sucralfate	SUCRALFATE	Pacific Pharma, Inc.	7407c58e-766f-4e93-a1bb-c77892ae0174	2024-02-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019183 application number: NDA019183
Carafate	SUCRALFATE	Allergan, Inc.	0fb67b1c-b4c0-46f2-8a81-df1510e006aa	2023-06-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019183 application number: NDA019183

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
66689-790-99	66689079099	10 TRAY in 1 CASE (66689-790-99) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (66689-790-01)	10 tray	2012-08-16	0000-00-00	No	No	Current