Sucralfate

Product NDC: 50742-386
11-digit product format: 507420386
Labeler code: 50742
Product ID: 50742-386_03497f8d-e649-40bf-b5c9-2df985b0fab4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sucralfate
Dosage form: SUSPENSION
Route: ORAL
Labeler: Ingenus Pharmaceuticals, LLC
Application: ANDA216726
Marketing category: ANDA
Marketing start: 2024-11-21
Marketing end: 2026-07-31
Substance: SUCRALFATE
Active strength: 1 g/10mL
Pharmacologic classes: Aluminum Complex [EPC], Organometallic Compounds [CS]
NDC exclude flag: No
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50742-386		D	Discontinued by firm		2026-08-17
excluded package	package	50742-386	50742-386-42	D	Discontinued by firm		2026-08-17

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
A216726-001	SUCRALFATE	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2024-03-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216726-001	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	A216726-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2024-03-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216726-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2024-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216726-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2024-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216726-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2024-03-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216726-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2024-03-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216726-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2024-03-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216726-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2024-03-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216726-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2024-03-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216726-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2024-03-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216726-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2024-03-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216726-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2024-03-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216726-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2024-03-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216726-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2024-03-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216726-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2024-03-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216726-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2024-03-21	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216726-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2024-03-21	`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	A216726-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216726-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216726-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216726-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216726-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216726-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216726-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216726-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216726-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216726-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216726-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216726-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216726-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216726-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216726-001	AB	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216726-001	AB	1	`a50c72e98297…`

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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50742-386-42	Sucralfate	420 mL in 1 BOTTLE	SUSPENSION	420		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50742-386-42	ML - Milliliter	50742-386	87ff8032-17bc-47b0-b5ce-11770e9534c9	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50742-386	SUCRALFATE SUSPENSION [INGENUS PHARMACEUTICALS, LLC]	5	Current NDC, 1 package rows	20241123_1921b3fc-f55c-e503-e063-6394a90a7da9.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sucralfate	SUCRALFATE	Torrent Pharmaceuticals Limited	dc361b46-fda4-4b0b-9950-e8885ba5b084	2025-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216726 application number: ANDA216726
Sucralfate	SUCRALFATE	Richmond Pharmaceuticals, Inc.	7ac10c3f-9d50-4702-900c-41075ac6f896	2025-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216726 application number: ANDA216726

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	1921b3fc-f55c-e503-e063-6394a90a7da9	6
313123	sucralfate 100 MG/ML Oral Suspension	SCD	1921b3fc-f55c-e503-e063-6394a90a7da9	6
313123	sucralfate 1 GM per 10 ML Oral Suspension	SY	1921b3fc-f55c-e503-e063-6394a90a7da9	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50742-386-42	50742038642	420 mL in 1 BOTTLE (50742-386-42)	420 ml	2024-11-21	2026-07-31	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sucralfate Oral Suspension	Ingenus Pharmaceuticals, LLC \| Tulex Pharmaceuticals Inc.	2025-12-30	HUMAN PRESCRIPTION DRUG LABEL	6