FDA.reportPublic FDA data

Myorisan

Product NDC
61748-304
11-digit product format
617480304
Labeler code
61748
Product ID
61748-304_3e34f054-8b03-4d79-821c-593120c49ea2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isotretinoin
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Akorn Operating Company LLC
Application
ANDA076485
Marketing category
ANDA
Marketing start
2012-05-01
Marketing end
0000-00-00
Substance
ISOTRETINOIN
Active strength
40 mg/1
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8300c0f6-79a4-735b-88ec-d781bfffdb10Product name520260305
644afe93-ba9b-4043-8e40-a9fe9af2d5d7Product name220250616
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
e5fedfa5-6b96-4769-872b-95d1e7f3a85aProduct name120200415
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61748-304-012024-01-30C16284748780-11030e364-fd70-111a-e063-dadaa90a10e2Myorisan ® (isotretinoin capsules, USP) 10 mg, 20 mg, 30 mg, 40 mg
61748-304-112024-01-30C16284748780-11030e364-fd70-111a-e063-dadaa90a10e2Myorisan ® (isotretinoin capsules, USP) 10 mg, 20 mg, 30 mg, 40 mg
61748-304-132024-01-30C16284748780-11030e364-fd70-111a-e063-dadaa90a10e2Myorisan ® (isotretinoin capsules, USP) 10 mg, 20 mg, 30 mg, 40 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61748-304-01Myorisan5000 in 1 BAGCAPSULE, LIQUID FILLED500014
61748-304-11Myorisan10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1014
61748-304-11Myorisan10 in 1 CARTONCAPSULE, LIQUID FILLED1014
61748-304-13Myorisan3 in 1 CARTONCAPSULE, LIQUID FILLED314
61748-304-13Myorisan10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61748-304-11EA - Each61748-304f05bd951-e7c1-49ac-bd05-0f47d834a58612012-07-24
61748-304-13EA - Each61748-304700f986a-feef-42fa-89ed-5f8d72599ed412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOTRETINOINACTIVE INGREDIENTEH28UP18IFMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
ISOTRETINOINACTIVE MOIETYEH28UP18IFMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
.ALPHA.-TOCOPHEROL, DL-INACTIVE INGREDIENT7QWA1RIO01MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
ALCOHOLINACTIVE INGREDIENT3K9958V90MMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
AMMONIAINACTIVE INGREDIENT5138Q19F1XMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
GELATININACTIVE INGREDIENT2G86QN327LMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
HYDROGENATED SOYBEAN OILINACTIVE INGREDIENTA2M91M918CMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
SHELLACINACTIVE INGREDIENT46N107B71OMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
SORBITOLINACTIVE INGREDIENT506T60A25RMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
SOYBEAN OILINACTIVE INGREDIENT241ATL177AMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
ISOTRETINOINACTIVE INGREDIENTEH28UP18IFMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
ISOTRETINOINACTIVE MOIETYEH28UP18IFMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
SOYBEAN OILINACTIVE INGREDIENT241ATL177AMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61748-304MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [AKORN OPERATING COMPANY LLC]14Legacy NDC, 5 package rows20221220_51ff6346-9256-4c01-9f52-417d13f2df05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197843ISOtretinoin 10 MG Oral CapsulePSN51ff6346-9256-4c01-9f52-417d13f2df0514
197844ISOtretinoin 20 MG Oral CapsulePSN51ff6346-9256-4c01-9f52-417d13f2df0514
403930ISOtretinoin 30 MG Oral CapsulePSN51ff6346-9256-4c01-9f52-417d13f2df0514
197845ISOtretinoin 40 MG Oral CapsulePSN51ff6346-9256-4c01-9f52-417d13f2df0514
1242611MYORISAN 10 MG Oral CapsulePSN51ff6346-9256-4c01-9f52-417d13f2df0514
1242613MYORISAN 20 MG Oral CapsulePSN51ff6346-9256-4c01-9f52-417d13f2df0514
1663728MYORISAN 30 MG Oral CapsulePSN51ff6346-9256-4c01-9f52-417d13f2df0514
1242615MYORISAN 40 MG Oral CapsulePSN51ff6346-9256-4c01-9f52-417d13f2df0514
1242611isotretinoin 10 MG Oral Capsule [Myorisan]SBD51ff6346-9256-4c01-9f52-417d13f2df0514
1242613isotretinoin 20 MG Oral Capsule [Myorisan]SBD51ff6346-9256-4c01-9f52-417d13f2df0514
1663728isotretinoin 30 MG Oral Capsule [Myorisan]SBD51ff6346-9256-4c01-9f52-417d13f2df0514
1242615isotretinoin 40 MG Oral Capsule [Myorisan]SBD51ff6346-9256-4c01-9f52-417d13f2df0514
197843isotretinoin 10 MG Oral CapsuleSCD51ff6346-9256-4c01-9f52-417d13f2df0514
197844isotretinoin 20 MG Oral CapsuleSCD51ff6346-9256-4c01-9f52-417d13f2df0514
403930isotretinoin 30 MG Oral CapsuleSCD51ff6346-9256-4c01-9f52-417d13f2df0514
197845isotretinoin 40 MG Oral CapsuleSCD51ff6346-9256-4c01-9f52-417d13f2df0514
1242611Myorisan 10 MG Oral CapsuleSY51ff6346-9256-4c01-9f52-417d13f2df0514
1242613Myorisan 20 MG Oral CapsuleSY51ff6346-9256-4c01-9f52-417d13f2df0514
1663728Myorisan 30 MG Oral CapsuleSY51ff6346-9256-4c01-9f52-417d13f2df0514
1242615Myorisan 40 MG Oral CapsuleSY51ff6346-9256-4c01-9f52-417d13f2df0514
197844ISOtretinoin 20 MG Oral CapsulePSNd8429009-c317-4618-a971-b0c6f1280d1a2
197845ISOtretinoin 40 MG Oral CapsulePSNd8429009-c317-4618-a971-b0c6f1280d1a2
1242613MYORISAN 20 MG Oral CapsulePSNd8429009-c317-4618-a971-b0c6f1280d1a2
1242615MYORISAN 40 MG Oral CapsulePSNd8429009-c317-4618-a971-b0c6f1280d1a2
1242613isotretinoin 20 MG Oral Capsule [Myorisan]SBDd8429009-c317-4618-a971-b0c6f1280d1a2
1242615isotretinoin 40 MG Oral Capsule [Myorisan]SBDd8429009-c317-4618-a971-b0c6f1280d1a2
197844isotretinoin 20 MG Oral CapsuleSCDd8429009-c317-4618-a971-b0c6f1280d1a2
197845isotretinoin 40 MG Oral CapsuleSCDd8429009-c317-4618-a971-b0c6f1280d1a2
1242613Myorisan 20 MG Oral CapsuleSYd8429009-c317-4618-a971-b0c6f1280d1a2
1242615Myorisan 40 MG Oral CapsuleSYd8429009-c317-4618-a971-b0c6f1280d1a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61748-304-01617480304015000 CAPSULE, LIQUID FILLED in 1 BAG (61748-304-01) 2012-05-010000-00-00NoNoCurrent
61748-304-116174803041110 BLISTER PACK in 1 CARTON (61748-304-11) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK10 blister pack2012-05-010000-00-00NoNoCurrent
61748-304-13617480304133 BLISTER PACK in 1 CARTON (61748-304-13) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK3 blister pack2012-05-010000-00-00NoNoCurrent