Sucralfate

Product NDC: 81646-101
11-digit product format: 816460101
Labeler code: 81646
Product ID: 81646-101_a133247e-4e09-4ae5-ab23-65249886e139
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sucralfate
Dosage form: SUSPENSION
Route: ORAL
Labeler: PINNACLE PHARMA LLC
Application: NDA019183
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2020-01-27
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: 2022-12-31
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	81646-101		I	Inactivated by FDA		2026-08-17
excluded package	package	81646-101	81646-101-10	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81646-101-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81646-101-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81646-101-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81646-101-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81646-101-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81646-101-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	81646-101-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	81646-101-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	81646-101-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	81646-101-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	81646-101-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	81646-101-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	81646-101-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	81646-101-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	81646-101-10	`1332a3947898…`	`d4bfe170f9cd…`

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
N019183-001	CARAFATE	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL		RLD	1993-12-16

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL		RLD	1993-12-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL		RLD, RS	1993-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL		RLD, RS	1993-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL		RLD, RS	1993-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019183-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019183-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019183-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019183-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019183-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019183-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019183-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019183-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019183-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019183-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019183-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019183-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019183-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019183-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019183-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019183-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019183-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N019183-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019183-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019183-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019183-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019183-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019183-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019183-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019183-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019183-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019183-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019183-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019183-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019183-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019183-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019183-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019183-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019183-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019183-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019183-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019183-001	AB	1	`cb3db0bc1861…`

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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
81646-101-10	2023-01-30	C162847	48780-1	f386c649-9d7c-0266-e053-dadaa90a7c1a	Sucralfate Oral Suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81646-101-10	Sucralfate	10 mL in 1 CUP, UNIT-DOSE	SUSPENSION	10		8
81646-101-10	Sucralfate	72 in 1 BOX, UNIT-DOSE	SUSPENSION	72		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81646-101	SUCRALFATE SUSPENSION [PINNACLE PHARMA LLC]	8	Legacy NDC, 2 package rows	20210513_0281961f-78f7-4f3c-947f-c7d1c505ad71.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	Pacific Pharma, Inc.	7407c58e-766f-4e93-a1bb-c77892ae0174	2024-02-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019183 application number: NDA019183
Carafate	SUCRALFATE	Allergan, Inc.	0fb67b1c-b4c0-46f2-8a81-df1510e006aa	2023-06-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019183 application number: NDA019183

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	0281961f-78f7-4f3c-947f-c7d1c505ad71	8
313123	sucralfate 100 MG/ML Oral Suspension	SCD	0281961f-78f7-4f3c-947f-c7d1c505ad71	8
313123	sucralfate 1 GM per 10 ML Oral Suspension	SY	0281961f-78f7-4f3c-947f-c7d1c505ad71	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
81646-101-10	81646010110	72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (81646-101-10) > 10 mL in 1 CUP, UNIT-DOSE	2020-01-27	0000-00-00	No	No	Current