FDA.reportPublic FDA data

isotretinoin 25 MG Oral Capsule

RxCUI
1547561
RxNorm name
isotretinoin 25 MG Oral Capsule
Display name
isotretinoin 25 MG Oral Capsule
Full name
isotretinoin 25 MG Oral Capsule
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:49

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IsotretinoinISOTRETINOINZydus Pharmaceuticals USA Inc.31f62a49-4c6d-4ce3-a0ca-d159562370b12026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1547561
Absorica LDISOTRETINOINSun Pharmaceutical Industries, Inc.3ef0cff8-19c1-4441-b780-fca6c7ee16152026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1547561
ISOTRETINOINISOTRETINOINAurobindo Pharma Limited4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e62025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1547561
IsotretinoinISOTRETINOINActavis Pharma, Inc.1cf11710-f966-4529-8e08-02175f588bca2025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1547561
IsotretinoinISOTRETINOINZydus Lifesciences Limited245898e5-3a61-4d6a-8375-8b3a8b7364ac2025-06-04Exact identifier
rxcui: 1547561
IsotretinoinISOTRETINOINSun Pharmaceutical Industries, Inc.b44200ba-6672-4ea7-b151-7caec3f53c9c2024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1547561
IsotretinoinISOTRETINOINAmneal Pharmaceuticals NY LLC9f1c8971-c6dc-4708-848b-5cee50b6c32a2023-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1547561

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
1cf11710-f966-4529-8e08-02175f588bcaisotretinoin 25 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 25 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 25 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 25 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
9f1c8971-c6dc-4708-848b-5cee50b6c32aISOtretinoin 25 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 25 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
4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e6isotretinoin 25 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 25 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
b44200ba-6672-4ea7-b151-7caec3f53c9cisotretinoin 25 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 25 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
245898e5-3a61-4d6a-8375-8b3a8b7364acisotretinoin 25 MG Oral CapsuleSCD120250604
245898e5-3a61-4d6a-8375-8b3a8b7364acISOtretinoin 25 MG Oral CapsulePSN120250604
31f62a49-4c6d-4ce3-a0ca-d159562370b1isotretinoin 25 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
31f62a49-4c6d-4ce3-a0ca-d159562370b1ISOtretinoin 25 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