FDA.reportPublic FDA data

Sucralfate

Product NDC
29033-003
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

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 [STAT RX USA LLC]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

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
29033-003-0529033000305500 TABLET in 1 BOTTLE, PLASTIC (29033-003-05) 500 tablet2020-02-170000-00-00NoNoCurrent