Sucralfate

Product NDC
0713-0791
11-digit product format
007130791
Labeler code
0713
Product ID
0713-0791_27c19a55-ceb8-91c3-e063-6394a90a726e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sucralfate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA217126
Marketing category
ANDA
Marketing start
2024-12-19
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
0713-0791-75Sucralfate420 mL in 1 BOTTLESUSPENSION4202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0791-75ML - Milliliter0713-07912caafb96-24cd-4d2d-bd97-7f3590c9d7f512025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0791SUCRALFATE SUSPENSION [COSETTE PHARMACEUTICALS, INC.]2Current NDC, 1 package rows20241220_3054ce94-78a2-4da4-8b14-95311b412ab2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313123sucralfate 1 GM in 10 mL Oral SuspensionPSN3054ce94-78a2-4da4-8b14-95311b412ab22
313123sucralfate 100 MG/ML Oral SuspensionSCD3054ce94-78a2-4da4-8b14-95311b412ab22
313123sucralfate 1 GM per 10 ML Oral SuspensionSY3054ce94-78a2-4da4-8b14-95311b412ab22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0713-0791-7500713079175420 mL in 1 BOTTLE (0713-0791-75) 420 ml2024-12-19NoNoCurrent