FDA.reportPublic FDA data

Isotretinoin

Manufacturer
BLUEBAY SHANDONG CO.,LTD
Effective date
2021-11-19
Label type
BULK INGREDIENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:50:13

Label at a glance#

ProductIsotretinoin
Active ingredientISOTRETINOIN
Label structure1 sections

Label contents#

Full prescribing information#

Isotretinoin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8300c0f6-79a4-735b-88ec-d781bfffdb10Product name520260305
644afe93-ba9b-4043-8e40-a9fe9af2d5d7Product name220250616
e5fedfa5-6b96-4769-872b-95d1e7f3a85aProduct name120200415

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73309-342-01Isotretinoin1000 g in 1 JARPOWDER10001
73309-342-02Isotretinoin100 g in 1 JARPOWDER1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73309-342ISOTRETINOIN POWDER [BLUEBAY SHANDONG CO.,LTD]12 package rows20211121_2bb9bc89-0e3c-4261-9fb0-8b710d654799.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73309-34273309-342-01, 73309-342-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOTRETINOINEH28UP18IFACTIB

Source Document#

Source XML

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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IsotretinoinISOTRETINOINAmneal Pharmaceuticals LLCc2917c3d-3499-48a0-ba53-120cb979195d2026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isotretinoin
generic name: ISOTRETINOIN
IsotretinoinISOTRETINOINZydus Pharmaceuticals USA Inc.31f62a49-4c6d-4ce3-a0ca-d159562370b12026-08-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isotretinoin
generic name: ISOTRETINOIN
IsotretinoinISOTRETINOINActavis Pharma, Inc.1cf11710-f966-4529-8e08-02175f588bca2026-08-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isotretinoin
generic name: ISOTRETINOIN
Absorica LDISOTRETINOINSun Pharmaceutical Industries, Inc.3ef0cff8-19c1-4441-b780-fca6c7ee16152026-08-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ISOTRETINOIN
AmnesteemISOTRETINOINMylan Pharmaceuticals Inc.b2cb63c9-f825-4991-9a2c-6260f1bbcc2c2026-08-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ISOTRETINOIN
ClaravisISOTRETINOINTeva Pharmaceuticals USA, Inc.a31fd109-d0fd-4ab9-ba98-a3d64333c18d2026-07-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ISOTRETINOIN
IsotretinoinISOTRETINOINZydus Pharmaceuticals USA Inc.28948c32-a598-4bb5-bdb5-efbd87214d982026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isotretinoin
generic name: ISOTRETINOIN
ZENATANEISOTRETINOINBluePoint Laboratories486d4a4b-0de5-431a-bef7-dae6b0e4fa202026-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ISOTRETINOIN
IsotretinoinISOTRETINOINUpsher-Smith Laboratories, LLC08529687-26b2-41e5-b6fb-35b4c0d891fe2026-02-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isotretinoin
generic name: ISOTRETINOIN
IsotretinoinISOTRETINOINUpsher-Smith Laboratories, LLCc369e1c3-90c5-4768-9741-56c62253a2c42026-02-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isotretinoin
generic name: ISOTRETINOIN
ACCUTANEISOTRETINOINJG Pharma Inc.5b524a51-a16b-496e-b764-11c98c479c362026-01-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ISOTRETINOIN
IsotretinoinISOTRETINOINZydus Lifesciences Limited245898e5-3a61-4d6a-8375-8b3a8b7364ac2025-06-04Name fallback
brand name: Isotretinoin
generic name: ISOTRETINOIN
IsotretinoinISOTRETINOINZydus Lifesciences Limiteddae33df0-386c-4db5-9759-7096e770ed172024-11-30Name fallback
brand name: Isotretinoin
generic name: ISOTRETINOIN
IsotretinoinISOTRETINOINMayne Pharma0114567b-3bac-490d-b9eb-03a6c5d909352024-06-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isotretinoin
generic name: ISOTRETINOIN
IsotretinoinISOTRETINOINSun Pharmaceutical Industries, Inc.b44200ba-6672-4ea7-b151-7caec3f53c9c2024-01-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isotretinoin
generic name: ISOTRETINOIN
IsotretinoinISOTRETINOINAmneal Pharmaceuticals NY LLC9f1c8971-c6dc-4708-848b-5cee50b6c32a2023-08-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isotretinoin
generic name: ISOTRETINOIN
IsotretinoinISOTRETINOINMayne Pharma72867c88-070f-4608-bfef-cc5225ebce6d2022-11-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isotretinoin
generic name: ISOTRETINOIN
IsotretinoinISOTRETINOINMayne Pharmaebe1b3e3-1013-4cf6-bdc8-2baa3dc26e162022-11-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isotretinoin
generic name: ISOTRETINOIN
IsotretinoinISOTRETINOINUpsher-Smith Laboratories, LLCff1edbb8-ac0e-4563-9c2a-94385ce055e32022-10-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isotretinoin
generic name: ISOTRETINOIN

Reported adverse events (FAERS/openFDA)#

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