sucralfate

Product NDC: 0378-9205
11-digit product format: 003789205
Labeler code: 0378
Product ID: 0378-9205_107f926c-dcf7-4a04-a44a-e22ff1534f97
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sucralfate
Dosage form: SUSPENSION
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA212913
Marketing category: ANDA
Marketing start: 2022-09-22
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0378-9205		D	Discontinued by firm		2026-10-27
excluded package	package	0378-9205	0378-9205-35	D	Discontinued by firm		2026-10-27

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A212913-001	SUCRALFATE	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL			2022-09-12

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
2026-10-15 13:18:30	2026-09	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL		2022-09-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212913-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2022-09-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212913-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212913-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212913-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212913-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212913-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212913-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212913-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212913-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212913-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212913-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212913-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212913-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212913-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212913-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212913-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212913-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212913-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212913-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212913-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212913-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212913-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212913-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212913-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212913-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212913-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212913-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212913-001	AB	1	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212913-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
0378-9205-35	sucralfate	420 mL in 1 BOTTLE, PLASTIC	SUSPENSION	420		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-9205-35	ML - Milliliter	0378-9205	aae41962-ced9-4916-9acc-9192c2cbb57f	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-9205	SUCRALFATE SUSPENSION [MYLAN PHARMACEUTICALS INC.]	2	Legacy NDC, 1 package rows	20220924_1e781cc0-24ec-4028-8262-dcef9873ea1f.zip

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	1e781cc0-24ec-4028-8262-dcef9873ea1f	2
313123	sucralfate 100 MG/ML Oral Suspension	SCD	1e781cc0-24ec-4028-8262-dcef9873ea1f	2
313123	sucralfate 1 GM per 10 ML Oral Suspension	SY	1e781cc0-24ec-4028-8262-dcef9873ea1f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-9205-35	00378920535	420 mL in 1 BOTTLE, PLASTIC (0378-9205-35)	420 ml	2022-09-22	0000-00-00	No	No	Current