Sucralfate

Product NDC
0254-1011
Requested package NDC
0254-1011-96
11-digit product format
002541011
Labeler code
0254
Product ID
0254-1011_afd960c2-2c06-4f64-b895-ff24401b5090
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sucralfate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Par Pharmaceutical Inc.
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0254-10110254-1011-96DDiscontinued by firm2026-08-17

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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019183-001CARAFATESUCRALFATE1GM/10MLSUSPENSION / ORALRLD1993-12-16

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N019183-001CARAFATE1GM/10MLSUSPENSION / ORALRLD1993-12-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019183-001CARAFATE1GM/10MLSUSPENSION / ORALRLD, RS1993-12-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-1687673890dc5c…
2021-03-12 10:30 UTC2021-03N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-163f01610625f2…
2019-09-15 20:21 UTC2019-09N019183-001CARAFATE1GM/10MLSUSPENSION / ORALRLD, RS1993-12-16b00525d2431f…
2019-07-19 19:46 UTC2019-07N019183-001CARAFATE1GM/10MLSUSPENSION / ORALRLD, RS1993-12-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-163f0d92c62455…
2023-05-13 08:27 UTC2023-05N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16053a50430f4f…
2023-01-26 05:58 UTC2023-01N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N019183-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019183-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019183-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019183-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019183-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019183-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019183-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019183-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019183-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019183-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019183-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019183-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019183-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019183-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019183-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019183-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019183-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N019183-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019183-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019183-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N019183-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019183-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019183-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019183-001AB13f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019183-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019183-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019183-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019183-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019183-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019183-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019183-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N019183-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N019183-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019183-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019183-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019183-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019183-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
01e96ee1-fe82-0132-025c-ec1559bf8b6eProduct name520260127
f9fa5fa8-e047-2182-3e2c-c4a9ec6531cdProduct name320240508
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0254-1011-96ML - Milliliter0254-1011860c8acc-16a5-41ab-bdf3-6826c6399d4d12020-02-13

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SucralfateSUCRALFATEPacific Pharma, Inc.7407c58e-766f-4e93-a1bb-c77892ae01742024-02-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 019183
application number: NDA019183
CarafateSUCRALFATEAllergan, Inc.0fb67b1c-b4c0-46f2-8a81-df1510e006aa2023-06-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 019183
application number: NDA019183

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313123sucralfate 1 GM in 10 mL Oral SuspensionPSN0281961f-78f7-4f3c-947f-c7d1c505ad718
313123sucralfate 100 MG/ML Oral SuspensionSCD0281961f-78f7-4f3c-947f-c7d1c505ad718
313123sucralfate 1 GM per 10 ML Oral SuspensionSY0281961f-78f7-4f3c-947f-c7d1c505ad718

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0254-1011-9600254101196420 mL in 1 BOTTLE (0254-1011-96) 420 ml2020-01-270000-00-00NoNoCurrent