FDA.reportPublic FDA data

NDC 59572-210-15 - Thalomid

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
59572-210
Requested NDC
59572-210-15
Package NDCs from labels
59572-210-15, 59572-210-95
Manufacturer
Celgene Corporation
Effective date
2023-03-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Thalomid - Celgene CorporationCelgene Corporation2023-03-24HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59572-210-15Thalomid28 in 1 BLISTER PACKCAPSULE2825
59572-210-95Thalomid5 in 1 BOXCAPSULE525

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59572-210THALOMID (THALIDOMIDE) CAPSULE [CELGENE CORPORATION]25Current NDC, Legacy NDC, 2 package rows20230406_2eda833b-1357-4ed4-a093-194524fcb061.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59572-210-15EA - Each59572-210fd9b990e-47ec-464d-af98-02d0a7fbcc3d12012-07-24
59572-210-95EA - Each59572-210f1a1c5b7-c449-43a8-a25d-fd0f0ba1036f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
THALIDOMIDEACTIVE INGREDIENT4Z8R6ORS6LTHALOMID (THALIDOMIDE) CAPSULE [CELGENE CORPORATION]12
THALIDOMIDEACTIVE MOIETY4Z8R6ORS6LTHALOMID (THALIDOMIDE) CAPSULE [CELGENE CORPORATION]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30THALOMID (THALIDOMIDE) CAPSULE [CELGENE CORPORATION]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTHALOMID (THALIDOMIDE) CAPSULE [CELGENE CORPORATION]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 1 of 1 ยท 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
ThalomidTHALIDOMIDECelgene Corporation2eda833b-1357-4ed4-a093-194524fcb0612023-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA020785
ndc (package): 59572-205-94
ndc (package): 59572-215-93
ndc (package): 59572-210-15
ndc (package): 59572-220-16
ndc (package): 59572-215-13
ndc (package): 59572-205-97
ndc (package): 59572-220-96
ndc (package): 59572-210-95
ndc (package): 59572-205-14
ndc (package): 59572-205-17
ndc (product): 59572-210
ndc (product): 59572-215
ndc (product): 59572-220
ndc (product): 59572-205
ndc11 (package): 59572021015
rxcui: 404449
rxcui: 360177
rxcui: 700418
rxcui: 360176
rxcui: 200390
rxcui: 700416
rxcui: 404450
rxcui: 213360
spl id: 58b287d1-24f5-4dfe-84ca-898a8a5b9302
spl set id: 2eda833b-1357-4ed4-a093-194524fcb061
unii: 4Z8R6ORS6L

Reported adverse events (FAERS/openFDA)#

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