Sucralfate

Product NDC: 67046-1469
11-digit product format: 670461469
Labeler code: 67046
Product ID: 67046-1469_2d5893c4-5f80-adea-e063-6294a90ae3e9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sucralfate
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA215705
Marketing category: ANDA
Marketing start: 2025-02-04
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
A215705-001	SUCRALFATE	SUCRALFATE	1GM	TABLET / ORAL	AB		2023-05-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215705-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215705-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2023-05-03	`a50c72e98297…`

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	A215705-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215705-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215705-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215705-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215705-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215705-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215705-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215705-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215705-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215705-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215705-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215705-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215705-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215705-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215705-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215705-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215705-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215705-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215705-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215705-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215705-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215705-001	AB	1	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215705-001	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
2d586736-73ae-9af0-e063-6294a90ad875	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
67046-1469-3	Sucralfate	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-1469	SUCRALFATE TABLET [COUPLER LLC]	1	Current NDC, 1 package rows	20250206_2d586736-73ae-9af0-e063-6294a90ad875.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sucralfate	SUCRALFATE	Zydus Lifesciences Limited	882b7596-f62c-4be2-8f67-e64310718baa	2026-08-08	Adverse reactions	Exact identifier application applno (ANDA): 215705 application number: ANDA215705
Sucralfate	SUCRALFATE	Viona Pharmaceuticals Inc	c708201b-2618-4470-a3ff-8ecf04d6b3a0	2026-08-08	Adverse reactions	Exact identifier application applno (ANDA): 215705 application number: ANDA215705
Sucralfate	SUCRALFATE	NCS HealthCare of KY, LLC dba Vangard Labs	3b0259fa-806f-44c1-8deb-c11dbd84582d	2026-06-24	Adverse reactions	Exact identifier application applno (ANDA): 215705 application number: ANDA215705
Sucralfate	SUCRALFATE	Preferred Pharmaceuticals Inc	a434bf8f-cc60-4d84-a9a4-61c3ff6b700e	2026-01-21	Adverse reactions	Exact identifier application applno (ANDA): 215705 application number: ANDA215705
Sucralfate	SUCRALFATE	Redpharm Drug	3251e156-4c52-63b3-e063-6294a90a9a95	2025-12-18	Adverse reactions	Exact identifier application applno (ANDA): 215705 application number: ANDA215705
Sucralfate	SUCRALFATE	NuCare Pharmaceuticals, Inc.	31a7dcd0-e677-249a-e063-6294a90a75f6	2025-03-19	Adverse reactions	Exact identifier application applno (ANDA): 215705 application number: ANDA215705
Sucralfate	SUCRALFATE	Coupler LLC	2d586736-73ae-9af0-e063-6294a90ad875	2025-02-04	Adverse reactions	Exact identifier application applno (ANDA): 215705 application number: ANDA215705 ndc (product): 67046-1469
Sucralfate	SUCRALFATE	Bryant Ranch Prepack	a068e818-8da3-4f0d-88e0-acc88e76f3aa	2024-08-22	Adverse reactions	Exact identifier application applno (ANDA): 215705 application number: ANDA215705

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	2d586736-73ae-9af0-e063-6294a90ad875	1
314234	sucralfate 1000 MG Oral Tablet	SCD	2d586736-73ae-9af0-e063-6294a90ad875	1
314234	sucralfate 1 GM Oral Tablet	SY	2d586736-73ae-9af0-e063-6294a90ad875	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1469-3	67046146903	30 TABLET in 1 BLISTER PACK (67046-1469-3)	30 tablet	2025-02-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sucralfate Tablets USP, 1g	Coupler LLC \| Zydus Lifesciences Limited	2025-02-04	HUMAN PRESCRIPTION DRUG LABEL	1