sucralfate

Product NDC
0378-9205
11-digit product format
003789205
Labeler code
0378
Product ID
0378-9205_107f926c-dcf7-4a04-a44a-e22ff1534f97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sucralfate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA212913
Marketing category
ANDA
Marketing start
2022-09-22
Substance
SUCRALFATE
Active strength
1 g/10mL
Pharmacologic classes
Aluminum Complex [EPC], Organometallic Compounds [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
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
0378-9205-35sucralfate420 mL in 1 BOTTLE, PLASTICSUSPENSION4202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-9205-35ML - Milliliter0378-9205aae41962-ced9-4916-9acc-9192c2cbb57f12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-9205SUCRALFATE SUSPENSION [MYLAN PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 1 package rows20220924_1e781cc0-24ec-4028-8262-dcef9873ea1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313123sucralfate 1 GM in 10 mL Oral SuspensionPSN1e781cc0-24ec-4028-8262-dcef9873ea1f2
313123sucralfate 100 MG/ML Oral SuspensionSCD1e781cc0-24ec-4028-8262-dcef9873ea1f2
313123sucralfate 1 GM per 10 ML Oral SuspensionSY1e781cc0-24ec-4028-8262-dcef9873ea1f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-9205-3500378920535420 mL in 1 BOTTLE, PLASTIC (0378-9205-35) 420 ml2022-09-220000-00-00NoNoCurrent