Sucralfate

Product NDC
63629-1307
Requested package NDC
63629-1307-3
11-digit product format
636291307
Labeler code
63629
Product ID
63629-1307_fc785200-389b-e031-e053-6294a90a88f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sucralfate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA070848
Marketing category
ANDA
Marketing start
1996-11-11
Substance
SUCRALFATE
Active strength
1 g/1
Pharmacologic classes
Aluminum Complex [EPC], Organometallic Compounds [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-130763629-1307-3IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

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
A070848-001SUCRALFATESUCRALFATE1GMTABLET / ORALAB1996-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070848-001AB

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 06:07:402026-07A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-293f01610625f2…
2019-09-15 20:21 UTC2019-09A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070848-001SUCRALFATE1GMTABLET / ORALAB1996-03-29e64feba35796…

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 06:07:402026-07A070848-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070848-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070848-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070848-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070848-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070848-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070848-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070848-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070848-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070848-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070848-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070848-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070848-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070848-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070848-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070848-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070848-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070848-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070848-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070848-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070848-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070848-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A070848-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070848-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070848-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070848-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A070848-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A070848-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070848-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070848-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070848-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070848-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070848-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070848-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070848-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A070848-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A070848-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070848-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070848-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070848-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Sucralfate
Listing expiration
2026-12-31

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
2687d670-8af6-42a2-9081-fee112e80fc0Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1307-0Sucralfate28 in 1 BOTTLETABLET281015
63629-1307-1Sucralfate100 in 1 BOTTLETABLET1001015
63629-1307-2Sucralfate60 in 1 BOTTLETABLET601015
63629-1307-3Sucralfate30 in 1 BOTTLETABLET301015
63629-1307-4Sucralfate20 in 1 BOTTLETABLET201015
63629-1307-6Sucralfate150 in 1 BOTTLETABLET1501015
63629-1307-7Sucralfate90 in 1 BOTTLETABLET901015
63629-1307-8Sucralfate40 in 1 BOTTLETABLET401015
63629-1307-9Sucralfate120 in 1 BOTTLETABLET1201015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1307-1EA - Each63629-1307f95cea6f-bb60-4368-b153-7dfcbc66893b12012-07-24
63629-1307-2EA - Each63629-130733784a61-4f8e-4cfd-89cf-4649f50ae6ae12012-07-24
63629-1307-3EA - Each63629-1307cf20f35d-a174-44b6-afe3-d674983d1e9612012-07-24
63629-1307-4EA - Each63629-130713270fc0-eda4-4350-8b86-4432c81d579512012-07-24
63629-1307-5EA - Each63629-13070922d8d2-75fd-431f-b172-01e40793153012012-07-24
63629-1307-6EA - Each63629-1307e0297835-bf47-423b-891c-aa8c660d59c412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SUCRALFATEACTIVE INGREDIENTXX73205DH5SUCRALFATE TABLET [BRYANT RANCH PREPACK]1004
SUCRALFATEACTIVE MOIETYXX73205DH5SUCRALFATE TABLET [BRYANT RANCH PREPACK]1004
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUCRALFATE TABLET [BRYANT RANCH PREPACK]1004
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUCRALFATE TABLET [BRYANT RANCH PREPACK]1004
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSUCRALFATE TABLET [BRYANT RANCH PREPACK]1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1307SUCRALFATE TABLET [BRYANT RANCH PREPACK]1015Current NDC, Legacy NDC, 9 package rows20230525_2687d670-8af6-42a2-9081-fee112e80fc0.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SucralfateSUCRALFATECardinal Health 107, LLC444a743a-4843-4b33-bad5-3dfc1fb2d0042026-07-29Adverse reactionsExact identifier
application applno (ANDA): 070848
application number: ANDA070848
SucralfateSUCRALFATECardinal Health 107, LLC1eb38f64-4d5a-46e6-a030-057beece5e442026-07-10Adverse reactionsExact identifier
application applno (ANDA): 070848
application number: ANDA070848
SucralfateSUCRALFATEASCLEMED USA INC.cd25eb96-29ea-48b2-bdee-c2ea98f216b82026-05-18Adverse reactionsExact identifier
application applno (ANDA): 070848
application number: ANDA070848
SucralfateSUCRALFATESafecor Health LLC1a6d96f2-fe1f-4aaf-8520-616973c224aa2026-04-07Adverse reactionsExact identifier
application applno (ANDA): 070848
application number: ANDA070848
SucralfateSUCRALFATENorthwind Health Company, LLC464bf611-4dbb-4707-b9dd-39ca178ed4bf2025-12-26Adverse reactionsExact identifier
application applno (ANDA): 070848
application number: ANDA070848
SucralfateSUCRALFATEPreferred Pharmaceuticals Inc.5ec71444-cc55-47bd-8abc-b3cfc3b47d8e2025-09-24Adverse reactionsExact identifier
application applno (ANDA): 070848
application number: ANDA070848
SucralfateSUCRALFATEMylan Institutional Inc.989ca8a8-3ad6-4ee4-aa9c-eed7318287532025-07-22Adverse reactionsExact identifier
application applno (ANDA): 070848
application number: ANDA070848
SucralfateSUCRALFATENCS HealthCare of KY, LLC dba Vangard Labsd67dcaad-56c1-4e77-a0c8-6559708084142025-06-13Adverse reactionsExact identifier
application applno (ANDA): 070848
application number: ANDA070848
SUCRALFATESUCRALFATEDIRECT RXc50b5044-31ed-672a-e053-2995a90a49fc2025-01-20Adverse reactionsExact identifier
application applno (ANDA): 070848
application number: ANDA070848
SucralfateSUCRALFATEAdvanced Rx of Tennessee, LLCb39f22c8-f224-451a-e053-2995a90aaad72024-12-31Adverse reactionsExact identifier
application applno (ANDA): 070848
application number: ANDA070848
SucralfateSUCRALFATENuCare Pharmaceuticals,Inc.a40e43d4-9240-34ad-e053-2995a90a98e12024-07-15Adverse reactionsExact identifier
application applno (ANDA): 070848
application number: ANDA070848
SucralfateSUCRALFATEProficient Rx LPa42c5f3d-85f1-485b-91e6-58c25b3ddc712024-01-01Adverse reactionsExact identifier
application applno (ANDA): 070848
application number: ANDA070848
SucralfateSUCRALFATEBryant Ranch Prepack2687d670-8af6-42a2-9081-fee112e80fc02023-05-24Adverse reactionsExact identifier
application applno (ANDA): 070848
application number: ANDA070848
ndc (package): 63629-1307-3
ndc (product): 63629-1307
ndc11 (package): 63629130703
SucralfateSUCRALFATETeva Pharmaceuticals USA, Inc.c7a43df7-eb37-4273-9250-87953b1fd2702015-09-01Adverse reactionsExact identifier
application applno (ANDA): 070848
application number: ANDA070848

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314234sucralfate 1 GM Oral TabletPSN2687d670-8af6-42a2-9081-fee112e80fc01015
314234sucralfate 1000 MG Oral TabletSCD2687d670-8af6-42a2-9081-fee112e80fc01015
314234sucralfate 1 GM Oral TabletSY2687d670-8af6-42a2-9081-fee112e80fc01015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1307-36362913070330 TABLET in 1 BOTTLE (63629-1307-3) 30 tablet2008-09-190000-00-00NoNoCurrent