Carafate

Product NDC
17856-0170
11-digit product format
178560170
Labeler code
17856
Product ID
17856-0170_c29af205-9e17-4d8c-8259-8874a9eb7591
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sucralfate
Dosage form
SUSPENSION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
NDA019183
Marketing category
NDA
Marketing start
1993-12-16
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct17856-0170IInactivated by FDA2026-08-17
excluded packagepackage17856-017017856-0170-1IInactivated by FDA2026-08-17
excluded packagepackage17856-017017856-0170-3IInactivated by FDA2026-08-17

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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0170-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0170-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0170-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0170-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0170-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0170-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0170-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0170-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17856-0170-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17856-0170-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17856-0170-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17856-0170-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-0170-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-0170-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-0170-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-0170-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-0170-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-0170-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17856-0170-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17856-0170-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17856-0170-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17856-0170-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17856-0170-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17856-0170-3557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage17856-0170-18af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage17856-0170-38af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage17856-0170-1834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage17856-0170-3834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-0170-11332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-0170-31332a3947898…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-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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0170-12023-01-30C16284748780-1f386c649-fdcf-0266-e053-dadaa90a7c1aCARAFATE (sucralfate) Suspension
17856-0170-32023-01-30C16284748780-1f386c649-fdcf-0266-e053-dadaa90a7c1aCARAFATE (sucralfate) Suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0170-1Carafate10 mL in 1 CUPSUSPENSION106
17856-0170-3Carafate10 mL in 1 CUP, UNIT-DOSESUSPENSION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0170CARAFATE (SUCRALFATE) SUSPENSION [ATLANTIC BIOLOGICALS CORP.]6Legacy NDC, 2 package rows20210128_64ae3d08-5651-463e-a255-9004100433e7.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
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
208094Carafate 1 GM in 10 mL Oral SuspensionPSN64ae3d08-5651-463e-a255-9004100433e76
313123sucralfate 1 GM in 10 mL Oral SuspensionPSN64ae3d08-5651-463e-a255-9004100433e76
208094sucralfate 100 MG/ML Oral Suspension [Carafate]SBD64ae3d08-5651-463e-a255-9004100433e76
313123sucralfate 100 MG/ML Oral SuspensionSCD64ae3d08-5651-463e-a255-9004100433e76
208094Carafate 1 GM per 10 ML Oral SuspensionSY64ae3d08-5651-463e-a255-9004100433e76
208094Carafate 100 MG/ML Oral SuspensionSY64ae3d08-5651-463e-a255-9004100433e76
313123sucralfate 1 GM per 10 ML Oral SuspensionSY64ae3d08-5651-463e-a255-9004100433e76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0170-11785601700110 mL in 1 CUP (17856-0170-1) 10 ml2021-01-260000-00-00NoNoCurrent
17856-0170-31785601700310 mL in 1 CUP, UNIT-DOSE (17856-0170-3) 10 ml2021-01-260000-00-00NoNoCurrent