FDA.reportPublic FDA data

NDC 69339-209-01 - Sucralfate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
69339-209
Requested NDC
69339-209-01
Package NDCs from labels
69339-209-01, 69339-209-17, 69339-209-19
Manufacturer
Natco Pharma USA LLC
Effective date
2024-07-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sucralfate - Natco Pharma USA LLCNatco Pharma USA LLC2024-07-03HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69339-209-172026-01-29Sucralfate Oral Suspension
69339-209-192026-01-29Sucralfate Oral Suspension
69339-209-172025-07-29Sucralfate Oral Suspension
69339-209-192025-07-29Sucralfate Oral Suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69339-209-01Sucralfate10 mL in 1 CUP, UNIT-DOSESUSPENSION105
69339-209-17Sucralfate10 in 1 TRAYSUSPENSION105
69339-209-17Sucralfate4 in 1 CASESUSPENSION45
69339-209-19Sucralfate10 in 1 CASESUSPENSION105
69339-209-19Sucralfate10 in 1 TRAYSUSPENSION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69339-209SUCRALFATE SUSPENSION [NATCO PHARMA USA LLC]55 package rows20240802_c76c7bcb-d481-43ff-809b-da8e0e88f096.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69339-209-01ML - Milliliter69339-209e5eced45-5c0c-444a-b8c0-58f3ffc5347712024-08-12
69339-209-17ML - Milliliter69339-209a18cbd51-1a29-45b3-81b5-2db38b984c7312024-08-12
69339-209-19ML - Milliliter69339-209a54326f5-92de-4c29-8894-e75476d3c61c12024-08-12

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 56 of 56 · 1,102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SucralfateSUCRALFATETeva Pharmaceuticals USA, Inc.c7a43df7-eb37-4273-9250-87953b1fd2702015-09-01Adverse reactionsExact identifier
unii: XX73205DH5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.