Sucralfate

Product NDC: 71610-017
11-digit product format: 716100017
Labeler code: 71610
Product ID: 71610-017_8527dc6d-ebec-4ba3-91be-59553b69aef6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sucralfate
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA018333
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2017-09-25
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
N018333-001	CARAFATE	SUCRALFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018333-001	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	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`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	N018333-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018333-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018333-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018333-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018333-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018333-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018333-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018333-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018333-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018333-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018333-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018333-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018333-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018333-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018333-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018333-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018333-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018333-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018333-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018333-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018333-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018333-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018333-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018333-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018333-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018333-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018333-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018333-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018333-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018333-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018333-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018333-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018333-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018333-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018333-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018333-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018333-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018333-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018333-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018333-001	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
84447e21-e311-4e9f-9065-53956e90135c	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	SPL version
71610-017-60	Sucralfate	90 in 1 BOTTLE	TABLET	90	2
71610-017-70	Sucralfate	120 in 1 BOTTLE	TABLET	120	2
71610-017-94	Sucralfate	360 in 1 BOTTLE	TABLET	360	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-017-60	EA - Each	71610-017	ff3dbb87-2ebc-49e8-9269-826a4620fc21	1	2018-03-08
71610-017-70	EA - Each	71610-017	00eb04b0-3fb4-4ad5-b495-cf27a092ba14	1	2019-05-02
71610-017-94	EA - Each	71610-017	198bfe51-6a42-49d3-8d43-e82434991f88	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-017	SUCRALFATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Current NDC, Legacy NDC, 3 package rows	20190424_84447e21-e311-4e9f-9065-53956e90135c.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sucralfate	SUCRALFATE	Northwind Health Company, LLC	f3095db3-fd02-873c-e053-2a95a90a5b1f	2026-01-01	Adverse reactions	Exact identifier application applno (NDA): 018333 application number: NDA018333
Sucralfate	SUCRALFATE	Preferred Pharmaceuticals Inc.	536b8c00-13ab-4397-a754-63a1c92bf883	2025-09-24	Adverse reactions	Exact identifier application applno (NDA): 018333 application number: NDA018333
Sucralfate	SUCRALFATE	Bryant Ranch Prepack	a73010fb-960c-4567-8ab1-6d902fee2c14	2025-06-02	Adverse reactions	Exact identifier application applno (NDA): 018333 application number: NDA018333
Sucralfate	SUCRALFATE	Advanced Rx Pharmacy of Tennessee, LLC	f15fbb45-4406-0d32-e053-2995a90a40c5	2024-12-31	Adverse reactions	Exact identifier application applno (NDA): 018333 application number: NDA018333
Carafate	SUCRALFATE	Allergan, Inc.	c87c6b50-6977-4fa7-ae98-40c0753f7aee	2024-05-21	Adverse reactions	Exact identifier application applno (NDA): 018333 application number: NDA018333
Sucralfate	SUCRALFATE	Advanced Rx Pharmacy of Tennessee, LLC	138f0929-caad-56c6-e063-6294a90a55ef	2024-03-13	Adverse reactions	Exact identifier application applno (NDA): 018333 application number: NDA018333
Sucralfate	SUCRALFATE	A-S Medication Solutions	793d033d-d341-4910-8dda-d43d8fd03a4d	2023-06-29	Adverse reactions	Exact identifier application applno (NDA): 018333 application number: NDA018333
Sucralfate	SUCRALFATE	Mylan Pharmaceuticals, Inc.	ae58c382-c1cf-4ebf-9c97-bdff0682df8b	2020-06-12	Adverse reactions	Exact identifier application applno (NDA): 018333 application number: NDA018333
Sucralfate	SUCRALFATE	Aphena Pharma Solutions - Tennessee, LLC	84447e21-e311-4e9f-9065-53956e90135c	2019-04-22	Adverse reactions	Exact identifier application applno (NDA): 018333 application number: NDA018333 ndc (product): 71610-017

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	84447e21-e311-4e9f-9065-53956e90135c	2
314234	sucralfate 1000 MG Oral Tablet	SCD	84447e21-e311-4e9f-9065-53956e90135c	2
314234	sucralfate 1 GM Oral Tablet	SY	84447e21-e311-4e9f-9065-53956e90135c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-017-60	71610001760	90 TABLET in 1 BOTTLE (71610-017-60)	90 tablet	2017-12-27	0000-00-00	No	No	Current
71610-017-70	71610001770	120 TABLET in 1 BOTTLE (71610-017-70)	120 tablet	2018-01-19	0000-00-00	No	No	Current
71610-017-94	71610001794	360 TABLET in 1 BOTTLE (71610-017-94)	360 tablet	2018-01-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sucralfate Tablets	Aphena Pharma Solutions - Tennessee, LLC	2019-04-22	HUMAN PRESCRIPTION DRUG LABEL	2