sucralfate

Product NDC
64380-149
11-digit product format
643800149
Labeler code
64380
Product ID
64380-149_a60083fe-4fc9-444d-a210-184ca92a4716
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sucralfate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA216474
Marketing category
ANDA
Marketing start
2024-07-10
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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-149-01sucralfate420 mL in 1 BOTTLE, PLASTICSUSPENSION4206
64380-149-02sucralfate10 mL in 1 CUP, UNIT-DOSESUSPENSION106
64380-149-03sucralfate5 in 1 TRAYSUSPENSION56
64380-149-04sucralfate3 in 1 CARTONSUSPENSION36
64380-149-04sucralfate10 in 1 TRAYSUSPENSION106
64380-149-05sucralfate4 in 1 CARTONSUSPENSION46
64380-149-05sucralfate10 in 1 TRAYSUSPENSION106
64380-149-06sucralfate5 in 1 CARTONSUSPENSION56
64380-149-06sucralfate10 in 1 TRAYSUSPENSION106
64380-149-07sucralfate10 in 1 TRAYSUSPENSION106
64380-149-07sucralfate10 in 1 CARTONSUSPENSION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-149-01ML - Milliliter64380-149c80459ab-18c0-44d6-9763-20c2cbcecb1112024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-149SUCRALFATE SUSPENSION [STRIDES PHARMA SCIENCE LIMITED]5Current NDC, 11 package rows20250316_8e25bff2-769e-4bd4-a6de-895c58b840d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313123sucralfate 1 GM in 10 mL Oral SuspensionPSNabc44549-ac41-4aef-9b15-2ba536e1555f103
313123sucralfate 100 MG/ML Oral SuspensionSCDabc44549-ac41-4aef-9b15-2ba536e1555f103
313123sucralfate 1 GM per 10 ML Oral SuspensionSYabc44549-ac41-4aef-9b15-2ba536e1555f103
313123sucralfate 1 GM in 10 mL Oral SuspensionPSN8e25bff2-769e-4bd4-a6de-895c58b840d26
313123sucralfate 100 MG/ML Oral SuspensionSCD8e25bff2-769e-4bd4-a6de-895c58b840d26
313123sucralfate 1 GM per 10 ML Oral SuspensionSY8e25bff2-769e-4bd4-a6de-895c58b840d26
313123sucralfate 1 GM in 10 mL Oral SuspensionPSN36d940f2-207b-68c5-e063-6294a90a6b4a1
313123sucralfate 100 MG/ML Oral SuspensionSCD36d940f2-207b-68c5-e063-6294a90a6b4a1
313123sucralfate 1 GM per 10 ML Oral SuspensionSY36d940f2-207b-68c5-e063-6294a90a6b4a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64380-149-0164380014901420 mL in 1 BOTTLE, PLASTIC (64380-149-01) 420 ml2024-07-10NoNoCurrent
64380-149-026438001490210 mL in 1 CUP, UNIT-DOSE10 mlHistorical
64380-149-03643800149035 CUP, UNIT-DOSE in 1 TRAY (64380-149-03) / 10 mL in 1 CUP, UNIT-DOSE (64380-149-02) 2024-07-10NoNoCurrent
64380-149-04643800149043 TRAY in 1 CARTON (64380-149-04) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (64380-149-02) 3 tray2024-07-10NoNoCurrent
64380-149-05643800149054 TRAY in 1 CARTON (64380-149-05) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (64380-149-02) 4 tray2024-07-10NoNoCurrent
64380-149-06643800149065 TRAY in 1 CARTON (64380-149-06) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (64380-149-02) 5 tray2024-07-10NoNoCurrent
64380-149-076438001490710 TRAY in 1 CARTON (64380-149-07) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (64380-149-02) 10 tray2024-07-10NoNoCurrent