FDA.reportPublic FDA data

ISOtretinoin 40 MG Oral Capsule

RxCUI
197845
RxNorm name
ISOtretinoin 40 MG Oral Capsule
Display name
ISOtretinoin 40 MG Oral Capsule
Full name
ISOtretinoin 40 MG Oral Capsule
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:51

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
IsotretinoinISOTRETINOINZydus Pharmaceuticals USA Inc.28948c32-a598-4bb5-bdb5-efbd87214d982026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197845
IsotretinoinISOTRETINOINZydus Pharmaceuticals USA Inc.31f62a49-4c6d-4ce3-a0ca-d159562370b12026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197845
Absorica LDISOTRETINOINSun Pharmaceutical Industries, Inc.3ef0cff8-19c1-4441-b780-fca6c7ee16152026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197845
ZENATANEISOTRETINOINBluePoint Laboratories486d4a4b-0de5-431a-bef7-dae6b0e4fa202026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197845
IsotretinoinISOTRETINOINUpsher-Smith Laboratories, LLCc369e1c3-90c5-4768-9741-56c62253a2c42026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197845
ACCUTANEISOTRETINOINJG Pharma Inc.5b524a51-a16b-496e-b764-11c98c479c362026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197845
ISOTRETINOINISOTRETINOINAurobindo Pharma Limited4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e62025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197845
IsotretinoinISOTRETINOINActavis Pharma, Inc.1cf11710-f966-4529-8e08-02175f588bca2025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197845
IsotretinoinISOTRETINOINZydus Lifesciences Limited245898e5-3a61-4d6a-8375-8b3a8b7364ac2025-06-04Exact identifier
rxcui: 197845
ZENATANEISOTRETINOINDr. Reddy's Laboratories Limited27b3cf26-f22e-5b70-1c24-009933b7c6ee2025-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197845
IsotretinoinISOTRETINOINZydus Lifesciences Limiteddae33df0-386c-4db5-9759-7096e770ed172024-11-30Exact identifier
rxcui: 197845
IsotretinoinISOTRETINOINMayne Pharma0114567b-3bac-490d-b9eb-03a6c5d909352024-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197845
AmnesteemISOTRETINOINMylan Pharmaceuticals Inc.b2cb63c9-f825-4991-9a2c-6260f1bbcc2c2024-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197845
IsotretinoinISOTRETINOINSun Pharmaceutical Industries, Inc.b44200ba-6672-4ea7-b151-7caec3f53c9c2024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197845
IsotretinoinISOTRETINOINAmneal Pharmaceuticals NY LLCc2917c3d-3499-48a0-ba53-120cb979195d2023-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197845
IsotretinoinISOTRETINOINAmneal Pharmaceuticals NY LLC9f1c8971-c6dc-4708-848b-5cee50b6c32a2023-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197845
IsotretinoinISOTRETINOINMayne Pharma72867c88-070f-4608-bfef-cc5225ebce6d2022-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197845
IsotretinoinISOTRETINOINUpsher-Smith Laboratories, LLCff1edbb8-ac0e-4563-9c2a-94385ce055e32022-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197845
ClaravisISOTRETINOINTeva Pharmaceuticals USA, Inc.a31fd109-d0fd-4ab9-ba98-a3d64333c18d2022-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197845

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
27b3cf26-f22e-5b70-1c24-009933b7c6eeisotretinoin 40 MG Oral CapsuleSCD27Isotretinoin Capsules USP20250207
27b3cf26-f22e-5b70-1c24-009933b7c6eeISOtretinoin 40 MG Oral CapsulePSN27Isotretinoin Capsules USP20250207
c2917c3d-3499-48a0-ba53-120cb979195dISOtretinoin 40 MG Oral CapsulePSN26Isotretinoin Capsules, USP 10 mg, 20 mg, 30 mg, 40 mg Rx Only20231230
c2917c3d-3499-48a0-ba53-120cb979195disotretinoin 40 MG Oral CapsuleSCD26Isotretinoin Capsules, USP 10 mg, 20 mg, 30 mg, 40 mg Rx Only20231230
b2cb63c9-f825-4991-9a2c-6260f1bbcc2cisotretinoin 40 MG Oral CapsuleSCD2320240623
b2cb63c9-f825-4991-9a2c-6260f1bbcc2cISOtretinoin 40 MG Oral CapsulePSN2320240623
1cf11710-f966-4529-8e08-02175f588bcaisotretinoin 40 MG Oral CapsuleSCD20These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 198220250722
1cf11710-f966-4529-8e08-02175f588bcaISOtretinoin 40 MG Oral CapsulePSN20These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 198220250722
3ef0cff8-19c1-4441-b780-fca6c7ee1615ISOtretinoin 40 MG Oral CapsulePSN18These highlights do not include all the information needed to use ABSORICA/ABSORICA LD safely and effectively. See full prescribing information for ABSORICA/ABSORICA LD. ABSORICA ® (isotretinoin) capsules, for oral use ABSORICA LD ® (isotretinoin) capsules, for oral use Initial U.S. Approval: 198220230612
3ef0cff8-19c1-4441-b780-fca6c7ee1615isotretinoin 40 MG Oral CapsuleSCD18These highlights do not include all the information needed to use ABSORICA/ABSORICA LD safely and effectively. See full prescribing information for ABSORICA/ABSORICA LD. ABSORICA ® (isotretinoin) capsules, for oral use ABSORICA LD ® (isotretinoin) capsules, for oral use Initial U.S. Approval: 198220230612
a31fd109-d0fd-4ab9-ba98-a3d64333c18dISOtretinoin 40 MG Oral CapsulePSN18CLARAVIS ™ (isotretinoin capsules USP)20220831
a31fd109-d0fd-4ab9-ba98-a3d64333c18disotretinoin 40 MG Oral CapsuleSCD18CLARAVIS ™ (isotretinoin capsules USP)20220831
51ff6346-9256-4c01-9f52-417d13f2df05isotretinoin 40 MG Oral CapsuleSCD14Myorisan ® (isotretinoin capsules, USP) 10 mg, 20 mg, 30 mg, 40 mg20221219
51ff6346-9256-4c01-9f52-417d13f2df05ISOtretinoin 40 MG Oral CapsulePSN14Myorisan ® (isotretinoin capsules, USP) 10 mg, 20 mg, 30 mg, 40 mg20221219
9f1c8971-c6dc-4708-848b-5cee50b6c32aISOtretinoin 40 MG Oral CapsulePSN9These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 198220230824
9f1c8971-c6dc-4708-848b-5cee50b6c32aisotretinoin 40 MG Oral CapsuleSCD9These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 198220230824
ff1edbb8-ac0e-4563-9c2a-94385ce055e3isotretinoin 40 MG Oral CapsuleSCD5These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 198220221024
ff1edbb8-ac0e-4563-9c2a-94385ce055e3ISOtretinoin 40 MG Oral CapsulePSN5These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 198220221024
0018861f-1b9b-431b-84ee-9d34aab615c3ISOtretinoin 40 MG Oral CapsulePSN520120625
0018861f-1b9b-431b-84ee-9d34aab615c3isotretinoin 40 MG Oral CapsuleSCD520120625
486d4a4b-0de5-431a-bef7-dae6b0e4fa20isotretinoin 40 MG Oral CapsuleSCD4Isotretinoin Capsules USP20260401
486d4a4b-0de5-431a-bef7-dae6b0e4fa20ISOtretinoin 40 MG Oral CapsulePSN4Isotretinoin Capsules USP20260401
0114567b-3bac-490d-b9eb-03a6c5d90935isotretinoin 40 MG Oral CapsuleSCD4Isotretinoin Capsules, USP20240626
0114567b-3bac-490d-b9eb-03a6c5d90935ISOtretinoin 40 MG Oral CapsulePSN4Isotretinoin Capsules, USP20240626
72867c88-070f-4608-bfef-cc5225ebce6disotretinoin 40 MG Oral CapsuleSCD4These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 198220221103
72867c88-070f-4608-bfef-cc5225ebce6dISOtretinoin 40 MG Oral CapsulePSN4These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 198220221103
ee862463-77c0-4694-bba8-97274f13963fisotretinoin 40 MG Oral CapsuleSCD4CLARAVIS™ (isotretinoin capsules USP)20140120
ee862463-77c0-4694-bba8-97274f13963fISOtretinoin 40 MG Oral CapsulePSN4CLARAVIS™ (isotretinoin capsules USP)20140120
c369e1c3-90c5-4768-9741-56c62253a2c4isotretinoin 40 MG Oral CapsuleSCD3Isotretinoin Capsules, USP 10 mg, 20 mg, 30 mg, 40 mg20260213
c369e1c3-90c5-4768-9741-56c62253a2c4ISOtretinoin 40 MG Oral CapsulePSN3Isotretinoin Capsules, USP 10 mg, 20 mg, 30 mg, 40 mg20260213
5b524a51-a16b-496e-b764-11c98c479c36isotretinoin 40 MG Oral CapsuleSCD3Isotretinoin Capsules USP20260130
5b524a51-a16b-496e-b764-11c98c479c36ISOtretinoin 40 MG Oral CapsulePSN3Isotretinoin Capsules USP20260130
4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e6isotretinoin 40 MG Oral CapsuleSCD3These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 198220251009
4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e6ISOtretinoin 40 MG Oral CapsulePSN3These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 198220251009
dae33df0-386c-4db5-9759-7096e770ed17ISOtretinoin 40 MG Oral CapsulePSN2Isotretinoin Capsules, USP Rx Only CAUSES BIRTH DEFECTS20241130
dae33df0-386c-4db5-9759-7096e770ed17isotretinoin 40 MG Oral CapsuleSCD2Isotretinoin Capsules, USP Rx Only CAUSES BIRTH DEFECTS20241130
b44200ba-6672-4ea7-b151-7caec3f53c9cisotretinoin 40 MG Oral CapsuleSCD2These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 198220240110
b44200ba-6672-4ea7-b151-7caec3f53c9cISOtretinoin 40 MG Oral CapsulePSN2These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 198220240110
d8429009-c317-4618-a971-b0c6f1280d1aISOtretinoin 40 MG Oral CapsulePSN2Myorisan TM (isotretinoin capsules, USP) 10 mg, 20 mg, 40 mg20130102
d8429009-c317-4618-a971-b0c6f1280d1aisotretinoin 40 MG Oral CapsuleSCD2Myorisan TM (isotretinoin capsules, USP) 10 mg, 20 mg, 40 mg20130102
245898e5-3a61-4d6a-8375-8b3a8b7364acISOtretinoin 40 MG Oral CapsulePSN120250604
245898e5-3a61-4d6a-8375-8b3a8b7364acisotretinoin 40 MG Oral CapsuleSCD120250604
31f62a49-4c6d-4ce3-a0ca-d159562370b1ISOtretinoin 40 MG Oral CapsulePSN1These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 198220250505
31f62a49-4c6d-4ce3-a0ca-d159562370b1isotretinoin 40 MG Oral CapsuleSCD1These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 198220250505
28948c32-a598-4bb5-bdb5-efbd87214d98isotretinoin 40 MG Oral CapsuleSCD1Isotretinoin Capsules, USP Rx Only20230901
28948c32-a598-4bb5-bdb5-efbd87214d98ISOtretinoin 40 MG Oral CapsulePSN1Isotretinoin Capsules, USP Rx Only20230901
517810a4-76bb-4739-893f-1f2ba94a5d0cISOtretinoin 40 MG Oral CapsulePSN1Isotretinoin Capsules USP20140822
517810a4-76bb-4739-893f-1f2ba94a5d0cisotretinoin 40 MG Oral CapsuleSCD1Isotretinoin Capsules USP20140822
d5a26c5e-9c3e-4781-8c08-62b91d21a68disotretinoin 40 MG Oral CapsuleSCD1SOTRET ® ISOTRETINOIN CAPSULES20061107
d5a26c5e-9c3e-4781-8c08-62b91d21a68dISOtretinoin 40 MG Oral CapsulePSN1SOTRET ® ISOTRETINOIN CAPSULES20061107