FDA.reportPublic FDA data

NDC 73309-342-01 - 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
73309-342
Requested NDC
73309-342-01
Package NDCs from labels
73309-342-01, 73309-342-02
Manufacturer
BLUEBAY SHANDONG CO.,LTD
Effective date
2021-11-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Isotretinoin - BLUEBAY SHANDONG CO.,LTDBLUEBAY SHANDONG CO.,LTD2021-11-19BULK INGREDIENT

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

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 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 reactionsExact identifier
unii: EH28UP18IF
IsotretinoinISOTRETINOINZydus Pharmaceuticals USA Inc.31f62a49-4c6d-4ce3-a0ca-d159562370b12026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
IsotretinoinISOTRETINOINActavis Pharma, Inc.1cf11710-f966-4529-8e08-02175f588bca2026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
Absorica LDISOTRETINOINSun Pharmaceutical Industries, Inc.3ef0cff8-19c1-4441-b780-fca6c7ee16152026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
AmnesteemISOTRETINOINMylan Pharmaceuticals Inc.b2cb63c9-f825-4991-9a2c-6260f1bbcc2c2026-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
ClaravisISOTRETINOINTeva Pharmaceuticals USA, Inc.a31fd109-d0fd-4ab9-ba98-a3d64333c18d2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
IsotretinoinISOTRETINOINZydus Pharmaceuticals USA Inc.28948c32-a598-4bb5-bdb5-efbd87214d982026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
ZENATANEISOTRETINOINBluePoint Laboratories486d4a4b-0de5-431a-bef7-dae6b0e4fa202026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
IsotretinoinISOTRETINOINUpsher-Smith Laboratories, LLC08529687-26b2-41e5-b6fb-35b4c0d891fe2026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
IsotretinoinISOTRETINOINUpsher-Smith Laboratories, LLCc369e1c3-90c5-4768-9741-56c62253a2c42026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
ACCUTANEISOTRETINOINJG Pharma Inc.5b524a51-a16b-496e-b764-11c98c479c362026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
IsotretinoinISOTRETINOINZydus Lifesciences Limited245898e5-3a61-4d6a-8375-8b3a8b7364ac2025-06-04Exact identifier
unii: EH28UP18IF
IsotretinoinISOTRETINOINZydus Lifesciences Limiteddae33df0-386c-4db5-9759-7096e770ed172024-11-30Exact identifier
unii: EH28UP18IF
IsotretinoinISOTRETINOINMayne Pharma0114567b-3bac-490d-b9eb-03a6c5d909352024-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
IsotretinoinISOTRETINOINSun Pharmaceutical Industries, Inc.b44200ba-6672-4ea7-b151-7caec3f53c9c2024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
IsotretinoinISOTRETINOINAmneal Pharmaceuticals NY LLC9f1c8971-c6dc-4708-848b-5cee50b6c32a2023-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
IsotretinoinISOTRETINOINMayne Pharma72867c88-070f-4608-bfef-cc5225ebce6d2022-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
IsotretinoinISOTRETINOINMayne Pharmaebe1b3e3-1013-4cf6-bdc8-2baa3dc26e162022-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
IsotretinoinISOTRETINOINUpsher-Smith Laboratories, LLCff1edbb8-ac0e-4563-9c2a-94385ce055e32022-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF

Reported adverse events (FAERS/openFDA)#

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