Sucralfate

Product NDC
59762-0401
11-digit product format
597620401
Labeler code
59762
Product ID
59762-0401_311db6f8-1bc9-46af-a866-d7ad4d8193dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sucralfate
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals, Inc.
Application
NDA018333
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2017-09-25
Substance
SUCRALFATE
Active strength
1 g/1
Pharmacologic classes
Aluminum Complex [EPC], Organometallic Compounds [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
N018333-001CARAFATESUCRALFATE1GMTABLET / ORALABRLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018333-001AB

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 06:07:402026-07N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018333-001CARAFATE1GMTABLET / ORALABRLD, RS, Approved before 1982e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N018333-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018333-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018333-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018333-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018333-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018333-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018333-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018333-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018333-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018333-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018333-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018333-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018333-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018333-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018333-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018333-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018333-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018333-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018333-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018333-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018333-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018333-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N018333-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018333-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018333-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018333-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N018333-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018333-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018333-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018333-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018333-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018333-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018333-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018333-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018333-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018333-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018333-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018333-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018333-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018333-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Sucralfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUCRALFATE1 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
XX73205DH5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
314234Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ae58c382-c1cf-4ebf-9c97-bdff0682df8bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
01e96ee1-fe82-0132-025c-ec1559bf8b6eProduct name520260127
f9fa5fa8-e047-2182-3e2c-c4a9ec6531cdProduct name320240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-0401-1Sucralfate100 in 1 BOTTLETABLET1008
59762-0401-5Sucralfate500 in 1 BOTTLETABLET5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0401-1EA - Each59762-04013ddd04f4-562e-4166-9142-62d72866d96612017-11-06
59762-0401-5EA - Each59762-04013a24233e-7ccb-4d0b-bef5-dc157a1d750812017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0401SUCRALFATE TABLET [GREENSTONE LLC]7Current NDC, Legacy NDC, 2 package rows20241109_ae58c382-c1cf-4ebf-9c97-bdff0682df8b.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SucralfateSUCRALFATENorthwind Health Company, LLCf3095db3-fd02-873c-e053-2a95a90a5b1f2026-01-01Adverse reactionsExact identifier
application applno (NDA): 018333
application number: NDA018333
SucralfateSUCRALFATEPreferred Pharmaceuticals Inc.536b8c00-13ab-4397-a754-63a1c92bf8832025-09-24Adverse reactionsExact identifier
application applno (NDA): 018333
application number: NDA018333
SucralfateSUCRALFATEBryant Ranch Prepacka73010fb-960c-4567-8ab1-6d902fee2c142025-06-02Adverse reactionsExact identifier
application applno (NDA): 018333
application number: NDA018333
SucralfateSUCRALFATEAdvanced Rx Pharmacy of Tennessee, LLCf15fbb45-4406-0d32-e053-2995a90a40c52024-12-31Adverse reactionsExact identifier
application applno (NDA): 018333
application number: NDA018333
CarafateSUCRALFATEAllergan, Inc.c87c6b50-6977-4fa7-ae98-40c0753f7aee2024-05-21Adverse reactionsExact identifier
application applno (NDA): 018333
application number: NDA018333
SucralfateSUCRALFATEAdvanced Rx Pharmacy of Tennessee, LLC138f0929-caad-56c6-e063-6294a90a55ef2024-03-13Adverse reactionsExact identifier
application applno (NDA): 018333
application number: NDA018333
SucralfateSUCRALFATEA-S Medication Solutions793d033d-d341-4910-8dda-d43d8fd03a4d2023-06-29Adverse reactionsExact identifier
application applno (NDA): 018333
application number: NDA018333
SucralfateSUCRALFATEMylan Pharmaceuticals, Inc.ae58c382-c1cf-4ebf-9c97-bdff0682df8b2020-06-12Adverse reactionsExact identifier
application applno (NDA): 018333
application number: NDA018333
ndc (product): 59762-0401
SucralfateSUCRALFATEAphena Pharma Solutions - Tennessee, LLC84447e21-e311-4e9f-9065-53956e90135c2019-04-22Adverse reactionsExact identifier
application applno (NDA): 018333
application number: NDA018333

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314234sucralfate 1 GM Oral TabletPSNae58c382-c1cf-4ebf-9c97-bdff0682df8b8
314234sucralfate 1000 MG Oral TabletSCDae58c382-c1cf-4ebf-9c97-bdff0682df8b8
314234sucralfate 1 GM Oral TabletSYae58c382-c1cf-4ebf-9c97-bdff0682df8b8
314234sucralfate 1 GM Oral TabletPSN793d033d-d341-4910-8dda-d43d8fd03a4d5
314234sucralfate 1000 MG Oral TabletSCD793d033d-d341-4910-8dda-d43d8fd03a4d5
314234sucralfate 1 GM Oral TabletSY793d033d-d341-4910-8dda-d43d8fd03a4d5
314234sucralfate 1 GM Oral TabletPSN536b8c00-13ab-4397-a754-63a1c92bf8834
314234sucralfate 1 GM Oral TabletPSN071cc50c-03cb-4a2e-8bbe-b04f3388cfed4
314234sucralfate 1000 MG Oral TabletSCD536b8c00-13ab-4397-a754-63a1c92bf8834
314234sucralfate 1000 MG Oral TabletSCD071cc50c-03cb-4a2e-8bbe-b04f3388cfed4
314234sucralfate 1 GM Oral TabletSY071cc50c-03cb-4a2e-8bbe-b04f3388cfed4
314234sucralfate 1 GM Oral TabletSY536b8c00-13ab-4397-a754-63a1c92bf8834
314234sucralfate 1 GM Oral TabletPSNf15fbb45-4406-0d32-e053-2995a90a40c53
314234sucralfate 1000 MG Oral TabletSCDf15fbb45-4406-0d32-e053-2995a90a40c53
314234sucralfate 1 GM Oral TabletSYf15fbb45-4406-0d32-e053-2995a90a40c53
314234sucralfate 1 GM Oral TabletPSNf3095db3-fd02-873c-e053-2a95a90a5b1f2
314234sucralfate 1 GM Oral TabletPSN84447e21-e311-4e9f-9065-53956e90135c2
314234sucralfate 1 GM Oral TabletPSN115e8d00-8a63-f159-e063-6394a90a9dcc2
314234sucralfate 1000 MG Oral TabletSCD84447e21-e311-4e9f-9065-53956e90135c2
314234sucralfate 1000 MG Oral TabletSCD115e8d00-8a63-f159-e063-6394a90a9dcc2
314234sucralfate 1000 MG Oral TabletSCDf3095db3-fd02-873c-e053-2a95a90a5b1f2
314234sucralfate 1 GM Oral TabletSY84447e21-e311-4e9f-9065-53956e90135c2
314234sucralfate 1 GM Oral TabletSY115e8d00-8a63-f159-e063-6394a90a9dcc2
314234sucralfate 1 GM Oral TabletSYf3095db3-fd02-873c-e053-2a95a90a5b1f2
314234sucralfate 1 GM Oral TabletPSNa73010fb-960c-4567-8ab1-6d902fee2c141
314234sucralfate 1 GM Oral TabletPSN138f0929-caad-56c6-e063-6294a90a55ef1
314234sucralfate 1000 MG Oral TabletSCDa73010fb-960c-4567-8ab1-6d902fee2c141
314234sucralfate 1000 MG Oral TabletSCD138f0929-caad-56c6-e063-6294a90a55ef1
314234sucralfate 1 GM Oral TabletSYa73010fb-960c-4567-8ab1-6d902fee2c141
314234sucralfate 1 GM Oral TabletSY138f0929-caad-56c6-e063-6294a90a55ef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-0401-159762040101100 TABLET in 1 BOTTLE (59762-0401-1) 100 tablet2017-09-250000-00-00NoNoCurrent
59762-0401-559762040105500 TABLET in 1 BOTTLE (59762-0401-5) 500 tablet2017-09-250000-00-00NoNoCurrent