FDA.reportPublic FDA data

NDC 70710-1024-08 - Isotretinoin

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
70710-1024
Requested NDC
70710-1024-08
Package NDCs from labels
70710-1024-8, 70710-1024-08
Manufacturer
Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited
Effective date
2026-07-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Isotretinoin - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2026-07-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1024-8Isotretinoin3 in 1 CARTONCAPSULE31
70710-1024-8Isotretinoin10 in 1 BLISTER PACKCAPSULE101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1024ISOTRETINOIN CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]1Current NDC, 2 package rows20230912_28948c32-a598-4bb5-bdb5-efbd87214d98.zip

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 291 of 298 · 5,942 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SpectricETHYLICUM, KALI BROMATUM, ASPARTIC ACID, L-DOPA, SEROTONIN (HYDROCHLORIDE), CEREBRUM SUIS, PLACENTA TOTALIS SUIS, AGARICUS MUSCARIUS, BUFO RANA, HELLEBORUS NIGER, HYOSCYAMUS NIGER, OLIBANUM (BOSWELLIA SERRATA), STRAMONIUM, THUJA OCCIDENTALIS, HELIUM, NEON, CARCINOSIN, HYDROGENDeseret Biologicals, Inc3e534017-4a9f-42a2-bdfd-1e8c73c0515a2022-11-08WarningsExact identifier
unii: 3K9958V90M
IsotretinoinISOTRETINOINMayne Pharma72867c88-070f-4608-bfef-cc5225ebce6d2022-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197845
unii: EH28UP18IF
IsotretinoinISOTRETINOINMayne Pharmaebe1b3e3-1013-4cf6-bdc8-2baa3dc26e162022-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197844
rxcui: 403930
rxcui: 197843
unii: EH28UP18IF
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
IsotretinoinISOTRETINOINUpsher-Smith Laboratories, LLCff1edbb8-ac0e-4563-9c2a-94385ce055e32022-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197845
unii: EH28UP18IF
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
REFRESH OPTIVECARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.7f8d88af-fd3b-4138-af61-f24c59ccebd72022-09-23WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: PDC6A3C0OX
DEFENSE Hand SanitizerISOPROPYL ALCOHOLWalla Walla Environmental, Inc.af49488d-5aeb-e3d9-e053-2a95a90afb042022-08-31WarningsExact identifier
unii: ND2M416302
DEFENSE Hand SanitizerISOPROPYL ALCOHOLWalla Walla Environmental, Inc.af498f92-6029-46b9-e053-2995a90a1c6d2022-08-31WarningsExact identifier
unii: ND2M416302
IntralipidI.V. FAT EMULSIONBaxter Healthcare CORP069460a5-3e9a-428f-b2dc-3405690f4fd72022-07-25Boxed warning, Adverse reactionsExact identifier
unii: 241ATL177A
IntralipidI.V. FAT EMULSIONBaxter Healthcare Corporation55609586-f0b4-42e6-8dd9-cd090afb5dca2022-07-21Boxed warning, Adverse reactionsExact identifier
unii: 241ATL177A
IntralipidI.V. FAT EMULSIONBaxter Healthcare Corporationa69c82da-15ba-4d4d-8d7f-871dc3981eb82022-07-21Boxed warning, Adverse reactionsExact identifier
unii: 241ATL177A
IntralipidI. V. FAT EMULSIONBaxter Healthcare Corporationdd269651-30e8-43f0-880f-484346eaafeb2022-07-21Boxed warning, Adverse reactionsExact identifier
unii: 241ATL177A
GlycerinumGLYCERINUMHahnemann Laboratories, INC.e34f8796-85b5-2946-e053-2995a90a251e2022-07-08Exact identifier
unii: PDC6A3C0OX
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ethylicum (ETOH, aka Alcoholus)ETHYLICUM (ETOH, AKA ALCOHOLUS)Hahnemann Laboratories, INC.e1fef03a-ed76-4294-e053-2995a90aee672022-06-21Exact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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