FDA.reportPublic FDA data

Sucralfate

Product NDC
0121-0974
11-digit product format
001210974
Labeler code
0121
Product ID
0121-0974_2271d920-944f-42ac-9de4-2c09447a55b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sucralfate
Dosage form
SUSPENSION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA211884
Marketing category
ANDA
Marketing start
2022-03-15
Substance
SUCRALFATE
Active strength
1 g/10mL
Pharmacologic classes
Aluminum Complex [EPC], Organometallic Compounds [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUCRALFATE1 g/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXX73205DH5
Rxcui313123

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
01e96ee1-fe82-0132-025c-ec1559bf8b6eProduct name520260127
f9fa5fa8-e047-2182-3e2c-c4a9ec6531cdProduct name320240508
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0974-00Sucralfate10 in 1 TRAYSUSPENSION106
0121-0974-10Sucralfate10 mL in 1 CUP, UNIT-DOSESUSPENSION106
0121-0974-40Sucralfate4 in 1 CASESUSPENSION46
0121-0974-40Sucralfate10 in 1 TRAYSUSPENSION106
0121-0974-50Sucralfate5 in 1 TRAYSUSPENSION56
0121-0974-50Sucralfate10 in 1 PACKAGESUSPENSION106
0121-0974-94Sucralfate3 in 1 CASESUSPENSION36
0121-0974-94Sucralfate10 in 1 TRAYSUSPENSION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0974-00ML - Milliliter0121-0974f00e0171-7f21-4759-95fd-9db0732d27f012022-11-07
0121-0974-10ML - Milliliter0121-0974b316a3df-3cac-4e30-b029-f6be868e295812022-11-07
0121-0974-40ML - Milliliter0121-0974e8459b92-2e2b-4d29-959e-5b056e073b9a12022-11-07
0121-0974-50ML - Milliliter0121-0974e34e67d0-9212-47e9-bf47-2a33d62d929212022-11-07
0121-0974-94ML - Milliliter0121-0974366d8610-7cdd-448d-9923-be8e4882017e12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0974SUCRALFATE SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]5Current NDC, Legacy NDC, 8 package rows20240316_113a068a-2ce9-421c-8b89-87ce30e19225.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313123sucralfate 1 GM in 10 mL Oral SuspensionPSN113a068a-2ce9-421c-8b89-87ce30e192256
313123sucralfate 100 MG/ML Oral SuspensionSCD113a068a-2ce9-421c-8b89-87ce30e192256
313123sucralfate 1 GM per 10 ML Oral SuspensionSY113a068a-2ce9-421c-8b89-87ce30e192256
313123sucralfate 1 GM in 10 mL Oral SuspensionPSN92c8672a-c6b8-4ec8-a815-c30bdd960ac75
313123sucralfate 1 GM in 10 mL Oral SuspensionPSNc76c7bcb-d481-43ff-809b-da8e0e88f0965
313123sucralfate 100 MG/ML Oral SuspensionSCD92c8672a-c6b8-4ec8-a815-c30bdd960ac75
313123sucralfate 100 MG/ML Oral SuspensionSCDc76c7bcb-d481-43ff-809b-da8e0e88f0965
313123sucralfate 1 GM per 10 ML Oral SuspensionSY92c8672a-c6b8-4ec8-a815-c30bdd960ac75
313123sucralfate 1 GM per 10 ML Oral SuspensionSYc76c7bcb-d481-43ff-809b-da8e0e88f0965

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0974-000012109740010 TRAY in 1 TRAY (0121-0974-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0974-10) 10 tray2022-08-310000-00-00NoNoCurrent
0121-0974-100012109741010 mL in 1 CUP, UNIT-DOSE10 mlHistorical
0121-0974-30001210974303 TRAY in 1 CASE (0121-0974-30) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (0121-0974-10) 3 tray2022-08-310000-00-00NoNoCurrent
0121-0974-40001210974404 TRAY in 1 CASE (0121-0974-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0974-10) 4 tray2022-08-310000-00-00NoNoCurrent
0121-0974-50001210974505 PACKAGE in 1 TRAY (0121-0974-50) / 10 CUP, UNIT-DOSE in 1 PACKAGE / 10 mL in 1 CUP, UNIT-DOSE (0121-0974-10) 5 package2022-08-310000-00-00NoNoCurrent
0121-0974-94001210974943 TRAY in 1 CASE (0121-0974-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0974-10) 3 tray2022-08-310000-00-00NoNoCurrent