Sucralfate

Product NDC: 68071-3478
11-digit product format: 680713478
Labeler code: 68071
Product ID: 68071-3478_2ad411ea-6bf6-b3bd-e063-6394a90af2e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sucralfate
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA074415
Marketing category: ANDA
Marketing start: 2020-02-17
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
A074415-001	SUCRALFATE	SUCRALFATE	1GM	TABLET / ORAL	AB		1998-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074415-001	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	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074415-001	SUCRALFATE	1GM	TABLET / ORAL		1998-06-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074415-001	SUCRALFATE	1GM	TABLET / ORAL		1998-06-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074415-001	SUCRALFATE	1GM	TABLET / ORAL		1998-06-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074415-001	SUCRALFATE	1GM	TABLET / ORAL		1998-06-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074415-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1998-06-08	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074415-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074415-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074415-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074415-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074415-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074415-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074415-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074415-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074415-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074415-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074415-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074415-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074415-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074415-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074415-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074415-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074415-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074415-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A074415-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074415-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074415-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074415-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074415-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074415-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074415-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074415-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074415-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074415-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074415-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074415-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074415-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074415-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074415-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074415-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074415-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074415-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074415-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A074415-001	AB	1	`a50c72e98297…`

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
0206d7fa-a1d5-35d9-e063-6294a90a5eb3	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	Strength	SPL version
68071-3478-3	Sucralfate	30 in 1 BOTTLE, PLASTIC	TABLET	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3478	SUCRALFATE TABLET [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, 1 package rows	20250105_0206d7fa-a1d5-35d9-e063-6294a90a5eb3.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sucralfate	SUCRALFATE	Chartwell RX, LLC	30c0965a-02a0-46b5-aa09-3f5fb5047b22	2026-07-06	Adverse reactions	Exact identifier application applno (ANDA): 074415 application number: ANDA074415
Sucralfate	SUCRALFATE	Direct_Rx	f5f0fecb-949c-3998-e053-2a95a90aac8c	2025-01-22	Adverse reactions	Exact identifier application applno (ANDA): 074415 application number: ANDA074415
Sucralfate	SUCRALFATE	NuCare Pharmaceuticals,Inc.	0206d7fa-a1d5-35d9-e063-6294a90a5eb3	2025-01-03	Adverse reactions	Exact identifier application applno (ANDA): 074415 application number: ANDA074415 ndc (product): 68071-3478
Sucralfate	SUCRALFATE	Advanced Rx Pharmacy of Tennessee, LLC	d3c41720-7e1a-08c1-e053-2a95a90aba03	2024-12-31	Adverse reactions	Exact identifier application applno (ANDA): 074415 application number: ANDA074415
Sucralfate	SUCRALFATE	Proficient Rx LP	51459cdb-a04a-49c2-8ee4-8f234f522476	2024-05-01	Adverse reactions	Exact identifier application applno (ANDA): 074415 application number: ANDA074415
Sucralfate	SUCRALFATE	Golden State Medical Supply, Inc.	15ad28fa-81ac-66d1-e063-6394a90aa3ea	2024-04-09	Adverse reactions	Exact identifier application applno (ANDA): 074415 application number: ANDA074415
Sucralfate	SUCRALFATE	Bryant Ranch Prepack	28d7d257-8545-4b9f-8412-8ba144502400	2024-02-23	Adverse reactions	Exact identifier application applno (ANDA): 074415 application number: ANDA074415
Sucralfate	SUCRALFATE	Bryant Ranch Prepack	7b05323d-4695-41d7-8236-1e7b4e8f2a1e	2024-01-11	Adverse reactions	Exact identifier application applno (ANDA): 074415 application number: ANDA074415
Sucralfate	SUCRALFATE	Bryant Ranch Prepack	25ae2ebc-a7e0-4fc9-a8d1-07f7dd7138e5	2024-01-11	Adverse reactions	Exact identifier application applno (ANDA): 074415 application number: ANDA074415
Sucralfate	SUCRALFATE	Bryant Ranch Prepack	370f5ac6-2c64-42ef-ab5d-075a473012f1	2023-05-22	Adverse reactions	Exact identifier application applno (ANDA): 074415 application number: ANDA074415
Sucralfate	SUCRALFATE	A-S Medication Solutions	03b66f88-d346-4260-867c-c942c4c68a79	2023-05-02	Adverse reactions	Exact identifier application applno (ANDA): 074415 application number: ANDA074415
Sucralfate	SUCRALFATE	Aphena Pharma Solutions - Tennessee, LLC	b414dc07-681c-4fde-965f-09df64c015e7	2021-05-19	Adverse reactions	Exact identifier application applno (ANDA): 074415 application number: ANDA074415

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	0206d7fa-a1d5-35d9-e063-6294a90a5eb3	2
314234	sucralfate 1000 MG Oral Tablet	SCD	0206d7fa-a1d5-35d9-e063-6294a90a5eb3	2
314234	sucralfate 1 GM Oral Tablet	SY	0206d7fa-a1d5-35d9-e063-6294a90a5eb3	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-3478-3	68071347803	30 TABLET in 1 BOTTLE, PLASTIC (68071-3478-3)	30 tablet	2023-08-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sucralfate Tablets, USP 1 gram	NuCare Pharmaceuticals,Inc.	2025-01-03	HUMAN PRESCRIPTION DRUG LABEL	2