FDA.reportPublic FDA data

NDC 60505-3947-03 - Adefovir dipivoxil

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
60505-3947
Requested NDC
60505-3947-03
Package NDCs from labels
60505-3947-3, 60505-3947-03
Manufacturer
Apotex Corp. | Apotex Inc.
Effective date
2025-07-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Adefovir dipivoxil - Apotex Corp. | Apotex Inc.Apotex Corp. | Apotex Inc.2025-07-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-3947-3Adefovir dipivoxil1 in 1 CARTONTABLET18
60505-3947-3Adefovir dipivoxil30 in 1 BOTTLETABLET308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-3947ADEFOVIR DIPIVOXIL TABLET [APOTEX CORP.]7Current NDC, Legacy NDC, 2 package rows20250412_08e07fae-3191-b6a3-c894-d3a8cc53923f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3947-3EA - Each60505-3947f666cf0b-d8c3-43e3-ab15-a23e1fa3b72e12018-10-11

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 9 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
Adefovir dipivoxilADEFOVIR DIPIVOXILApotex Corp.08e07fae-3191-b6a3-c894-d3a8cc53923f2025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205459
ndc (package): 60505-3947-3
ndc (product): 60505-3947
ndc11 (package): 60505394703
rxcui: 881341
spl id: bd0233d0-e141-a321-66a5-4afd09dbabfe
spl set id: 08e07fae-3191-b6a3-c894-d3a8cc53923f
unii: U6Q8Z01514
Steritalc 2gTALCNovatech SAc94e51d9-beef-4b06-e053-2a95a90a754a2025-06-25Warnings, Adverse reactionsExact identifier
unii: 7SEV7J4R1U
SENSITIVE POCKET SUNSENSITIVE POCKET SUNShantou Oushiya Biotechnology Co., Ltd36ac412f-e31f-6906-e063-6394a90a4a3d2025-06-14WarningsExact identifier
unii: 7SEV7J4R1U
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
ADEFOVIR DIPIVOXILADEFOVIR DIPIVOXILSigmapharm Laboratories, LLCe047f3b2-feae-4c5e-9d07-1fefb4c0ec252023-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 881341
unii: U6Q8Z01514

Reported adverse events (FAERS/openFDA)#

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