FDA.reportPublic FDA data

Sucralfate

Product NDC
68094-041
11-digit product format
680940041
Labeler code
68094
Product ID
68094-041_f2fb0919-1f13-4ca2-bf04-254c1e44b86c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sucralfate oral
Dosage form
SUSPENSION
Route
ORAL
Labeler
Precision Dose, Inc.
Application
ANDA209356
Marketing category
ANDA
Marketing start
2025-01-30
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
68094-041-59Sucralfate10 mL in 1 CUP, UNIT-DOSESUSPENSION102
68094-041-61Sucralfate10 in 1 TRAYSUSPENSION102
68094-041-61Sucralfate10 in 1 CASESUSPENSION102
68094-041-62Sucralfate10 in 1 TRAYSUSPENSION102
68094-041-62Sucralfate3 in 1 CASESUSPENSION32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-041-59ML - Milliliter68094-041d81ea45e-b5bb-4db8-b5a3-04118617831b12025-02-10
68094-041-61ML - Milliliter68094-04187632a1d-2a1c-4ce7-8999-a3941c1f6a3f12025-02-10
68094-041-62ML - Milliliter68094-041be0ab1d5-2fbb-41ad-a8ee-8677d969d1df12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-041SUCRALFATE (SUCRALFATE ORAL) SUSPENSION [PRECISION DOSE, INC.]2Current NDC, 5 package rows20250130_0dc592e9-541c-4fac-8ab5-829d43521c01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313123sucralfate 1 GM in 10 mL Oral SuspensionPSN0dc592e9-541c-4fac-8ab5-829d43521c012
313123sucralfate 100 MG/ML Oral SuspensionSCD0dc592e9-541c-4fac-8ab5-829d43521c012
313123sucralfate 1 GM per 10 ML Oral SuspensionSY0dc592e9-541c-4fac-8ab5-829d43521c012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68094-041-596809400415910 mL in 1 CUP, UNIT-DOSE10 mlHistorical
68094-041-616809400416110 TRAY in 1 CASE (68094-041-61) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-041-59) 10 tray2025-01-30NoNoHistorical
68094-041-62680940041623 TRAY in 1 CASE (68094-041-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-041-59) 3 tray2025-01-30NoNoHistorical