Sucralfate

Product NDC
29033-003
Requested package NDC
29033-003-01
11-digit product format
290330003
Labeler code
29033
Product ID
29033-003_60a4a349-5bb9-4685-86f8-b74068f1c614
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sucralfate
Dosage form
TABLET
Route
ORAL
Labeler
Nostrum Laboratories, Inc.
Application
ANDA074415
Marketing category
ANDA
Marketing start
2020-02-17
Marketing end
0000-00-00
Substance
SUCRALFATE
Active strength
1 g/1
Pharmacologic classes
Aluminum Complex [EPC],Organometallic Compounds [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage29033-00329033-003-01IInactivated by FDA2026-08-17

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
A074415-001SUCRALFATESUCRALFATE1GMTABLET / ORALAB1998-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074415-001AB

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 06:07:402026-07A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074415-001SUCRALFATE1GMTABLET / ORAL1998-06-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074415-001SUCRALFATE1GMTABLET / ORAL1998-06-083f01610625f2…
2019-09-15 20:21 UTC2019-09A074415-001SUCRALFATE1GMTABLET / ORAL1998-06-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A074415-001SUCRALFATE1GMTABLET / ORAL1998-06-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074415-001SUCRALFATE1GMTABLET / ORALAB1998-06-08e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074415-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074415-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074415-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074415-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074415-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074415-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074415-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074415-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074415-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074415-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074415-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074415-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074415-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074415-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074415-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074415-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074415-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074415-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A074415-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074415-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074415-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074415-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074415-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074415-001AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074415-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074415-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074415-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074415-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074415-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074415-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074415-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074415-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074415-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074415-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074415-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074415-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074415-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A074415-001AB1a50c72e98297…

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
29033-003-012026-01-29C16284748780-149896155-c45d-586f-e063-e6dba90add90Sucralfate Tablets, USP 1 gram
29033-003-052026-01-29C16284748780-149896155-c45d-586f-e063-e6dba90add90Sucralfate Tablets, USP 1 gram

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29033-003-01Sucralfate100 in 1 BOTTLE, PLASTICTABLET1005
29033-003-05Sucralfate500 in 1 BOTTLE, PLASTICTABLET5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29033-003-01EA - Each29033-003b5746e11-5b56-40f4-986f-4461147c39c512012-07-24
29033-003-05EA - Each29033-003f24cc57f-9933-4850-9ee3-bb28ca351aa912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SucralfateACTIVE INGREDIENTXX73205DH5SUCRALFATE TABLET [NOSTRUM LABORATORIES, INC.]3
SucralfateACTIVE MOIETYXX73205DH5SUCRALFATE TABLET [NOSTRUM LABORATORIES, INC.]3
Magnesium stearateINACTIVE INGREDIENT70097M6I30SUCRALFATE TABLET [NOSTRUM LABORATORIES, INC.]3
PovidoneINACTIVE INGREDIENTFZ989GH94ESUCRALFATE TABLET [NOSTRUM LABORATORIES, INC.]3
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4SUCRALFATE TABLET [NOSTRUM LABORATORIES, INC.]3
SucralfateACTIVE INGREDIENTXX73205DH5SUCRALFATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SUCRALFATEACTIVE INGREDIENTXX73205DH5SUCRALFATE TABLET [STAT RX USA LLC]1
SucralfateACTIVE MOIETYXX73205DH5SUCRALFATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SUCRALFATEACTIVE MOIETYXX73205DH5SUCRALFATE TABLET [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29033-003SUCRALFATE TABLET [NOSTRUM LABORATORIES, INC.]5Legacy NDC, 2 package rows20200227_ec2db707-3cad-473d-8a04-05f23574b612.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SucralfateSUCRALFATEChartwell RX, LLC30c0965a-02a0-46b5-aa09-3f5fb5047b222026-07-06Adverse reactionsExact identifier
application applno (ANDA): 074415
application number: ANDA074415
SucralfateSUCRALFATEDirect_Rxf5f0fecb-949c-3998-e053-2a95a90aac8c2025-01-22Adverse reactionsExact identifier
application applno (ANDA): 074415
application number: ANDA074415
SucralfateSUCRALFATENuCare Pharmaceuticals,Inc.0206d7fa-a1d5-35d9-e063-6294a90a5eb32025-01-03Adverse reactionsExact identifier
application applno (ANDA): 074415
application number: ANDA074415
SucralfateSUCRALFATEAdvanced Rx Pharmacy of Tennessee, LLCd3c41720-7e1a-08c1-e053-2a95a90aba032024-12-31Adverse reactionsExact identifier
application applno (ANDA): 074415
application number: ANDA074415
SucralfateSUCRALFATEProficient Rx LP51459cdb-a04a-49c2-8ee4-8f234f5224762024-05-01Adverse reactionsExact identifier
application applno (ANDA): 074415
application number: ANDA074415
SucralfateSUCRALFATEGolden State Medical Supply, Inc.15ad28fa-81ac-66d1-e063-6394a90aa3ea2024-04-09Adverse reactionsExact identifier
application applno (ANDA): 074415
application number: ANDA074415
SucralfateSUCRALFATEBryant Ranch Prepack28d7d257-8545-4b9f-8412-8ba1445024002024-02-23Adverse reactionsExact identifier
application applno (ANDA): 074415
application number: ANDA074415
SucralfateSUCRALFATEBryant Ranch Prepack7b05323d-4695-41d7-8236-1e7b4e8f2a1e2024-01-11Adverse reactionsExact identifier
application applno (ANDA): 074415
application number: ANDA074415
SucralfateSUCRALFATEBryant Ranch Prepack25ae2ebc-a7e0-4fc9-a8d1-07f7dd7138e52024-01-11Adverse reactionsExact identifier
application applno (ANDA): 074415
application number: ANDA074415
SucralfateSUCRALFATEBryant Ranch Prepack370f5ac6-2c64-42ef-ab5d-075a473012f12023-05-22Adverse reactionsExact identifier
application applno (ANDA): 074415
application number: ANDA074415
SucralfateSUCRALFATEA-S Medication Solutions03b66f88-d346-4260-867c-c942c4c68a792023-05-02Adverse reactionsExact identifier
application applno (ANDA): 074415
application number: ANDA074415
SucralfateSUCRALFATEAphena Pharma Solutions - Tennessee, LLCb414dc07-681c-4fde-965f-09df64c015e72021-05-19Adverse reactionsExact identifier
application applno (ANDA): 074415
application number: ANDA074415

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314234sucralfate 1 GM Oral TabletPSN7b05323d-4695-41d7-8236-1e7b4e8f2a1e102
314234sucralfate 1 GM Oral TabletPSN25ae2ebc-a7e0-4fc9-a8d1-07f7dd7138e5102
314234sucralfate 1000 MG Oral TabletSCD7b05323d-4695-41d7-8236-1e7b4e8f2a1e102
314234sucralfate 1000 MG Oral TabletSCD25ae2ebc-a7e0-4fc9-a8d1-07f7dd7138e5102
314234sucralfate 1 GM Oral TabletSY25ae2ebc-a7e0-4fc9-a8d1-07f7dd7138e5102
314234sucralfate 1 GM Oral TabletSY7b05323d-4695-41d7-8236-1e7b4e8f2a1e102
314234sucralfate 1 GM Oral TabletPSN370f5ac6-2c64-42ef-ab5d-075a473012f1101
314234sucralfate 1000 MG Oral TabletSCD370f5ac6-2c64-42ef-ab5d-075a473012f1101
314234sucralfate 1 GM Oral TabletSY370f5ac6-2c64-42ef-ab5d-075a473012f1101
314234sucralfate 1 GM Oral TabletPSN28d7d257-8545-4b9f-8412-8ba144502400100
314234sucralfate 1000 MG Oral TabletSCD28d7d257-8545-4b9f-8412-8ba144502400100
314234sucralfate 1 GM Oral TabletSY28d7d257-8545-4b9f-8412-8ba144502400100
314234sucralfate 1 GM Oral TabletPSNec2db707-3cad-473d-8a04-05f23574b6125
314234sucralfate 1000 MG Oral TabletSCDec2db707-3cad-473d-8a04-05f23574b6125
314234sucralfate 1 GM Oral TabletSYec2db707-3cad-473d-8a04-05f23574b6125
314234sucralfate 1 GM Oral TabletPSNd3c41720-7e1a-08c1-e053-2a95a90aba034
314234sucralfate 1000 MG Oral TabletSCDd3c41720-7e1a-08c1-e053-2a95a90aba034
314234sucralfate 1 GM Oral TabletSYd3c41720-7e1a-08c1-e053-2a95a90aba034
314234sucralfate 1 GM Oral TabletPSNe7364686-3638-4061-ae4a-62b1df7af9d03
314234sucralfate 1000 MG Oral TabletSCDe7364686-3638-4061-ae4a-62b1df7af9d03
314234sucralfate 1 GM Oral TabletSYe7364686-3638-4061-ae4a-62b1df7af9d03
314234sucralfate 1 GM Oral TabletPSNf5f0fecb-949c-3998-e053-2a95a90aac8c2
314234sucralfate 1 GM Oral TabletPSN0206d7fa-a1d5-35d9-e063-6294a90a5eb32
314234sucralfate 1000 MG Oral TabletSCDf5f0fecb-949c-3998-e053-2a95a90aac8c2
314234sucralfate 1000 MG Oral TabletSCD0206d7fa-a1d5-35d9-e063-6294a90a5eb32
314234sucralfate 1 GM Oral TabletSY0206d7fa-a1d5-35d9-e063-6294a90a5eb32
314234sucralfate 1 GM Oral TabletSYf5f0fecb-949c-3998-e053-2a95a90aac8c2
314234sucralfate 1 GM Oral TabletPSNb414dc07-681c-4fde-965f-09df64c015e71
314234sucralfate 1 GM Oral TabletPSNc7e61193-6f73-4ae6-9560-ff23003b959b1
314234sucralfate 1 GM Oral TabletPSN03b66f88-d346-4260-867c-c942c4c68a791
314234sucralfate 1 GM Oral TabletPSN51459cdb-a04a-49c2-8ee4-8f234f5224761
314234sucralfate 1 GM Oral TabletPSN15ad28fa-81ac-66d1-e063-6394a90aa3ea1
314234sucralfate 1000 MG Oral TabletSCD15ad28fa-81ac-66d1-e063-6394a90aa3ea1
314234sucralfate 1000 MG Oral TabletSCD03b66f88-d346-4260-867c-c942c4c68a791
314234sucralfate 1000 MG Oral TabletSCD51459cdb-a04a-49c2-8ee4-8f234f5224761
314234sucralfate 1000 MG Oral TabletSCDc7e61193-6f73-4ae6-9560-ff23003b959b1
314234sucralfate 1000 MG Oral TabletSCDb414dc07-681c-4fde-965f-09df64c015e71
314234sucralfate 1 GM Oral TabletSY15ad28fa-81ac-66d1-e063-6394a90aa3ea1
314234sucralfate 1 GM Oral TabletSY03b66f88-d346-4260-867c-c942c4c68a791
314234sucralfate 1 GM Oral TabletSYc7e61193-6f73-4ae6-9560-ff23003b959b1
314234sucralfate 1 GM Oral TabletSYb414dc07-681c-4fde-965f-09df64c015e71
314234sucralfate 1 GM Oral TabletSY51459cdb-a04a-49c2-8ee4-8f234f5224761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29033-003-0129033000301100 TABLET in 1 BOTTLE, PLASTIC (29033-003-01) 100 tablet2020-02-170000-00-00NoNoCurrent