FDA.reportPublic FDA data

Amnesteem

Product NDC
0378-6613
11-digit product format
003786613
Labeler code
0378
Product ID
0378-6613_8105505f-9df6-4bc4-b201-7281a2d3af00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isotretinoin
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA075945
Marketing category
ANDA
Marketing start
2025-04-10
Substance
ISOTRETINOIN
Active strength
30 mg/1
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amnesteem
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOTRETINOIN30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEH28UP18IF
Rxcui197843, 197844, 197845, 403930, 404058, 404061, 404064, 2711694

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-6613-85Amnesteem10 in 1 BLISTER PACKCAPSULE1023
0378-6613-93Amnesteem3 in 1 CARTONCAPSULE323

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6613-85EA - Each0378-66138d3dc274-7cf2-409b-804b-ae1316867e6112025-05-14
0378-6613-93EA - Each0378-6613ab153841-4a49-482b-9c2a-c6785a7e08ee12025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOTRETINOINACTIVE INGREDIENTEH28UP18IFAMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]7
ISOTRETINOINACTIVE MOIETYEH28UP18IFAMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]7
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UAMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]7
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]7
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]7
SOYBEAN OILINACTIVE INGREDIENT241ATL177AAMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]7
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VAMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-6613AMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]22Current NDC, 2 package rows20250412_b2cb63c9-f825-4991-9a2c-6260f1bbcc2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
404058Amnesteem 10 MG Oral CapsulePSNb2cb63c9-f825-4991-9a2c-6260f1bbcc2c23
404061Amnesteem 20 MG Oral CapsulePSNb2cb63c9-f825-4991-9a2c-6260f1bbcc2c23
2711694Amnesteem 30 MG Oral CapsulePSNb2cb63c9-f825-4991-9a2c-6260f1bbcc2c23
404064Amnesteem 40 MG Oral CapsulePSNb2cb63c9-f825-4991-9a2c-6260f1bbcc2c23
197843ISOtretinoin 10 MG Oral CapsulePSNb2cb63c9-f825-4991-9a2c-6260f1bbcc2c23
197844ISOtretinoin 20 MG Oral CapsulePSNb2cb63c9-f825-4991-9a2c-6260f1bbcc2c23
403930ISOtretinoin 30 MG Oral CapsulePSNb2cb63c9-f825-4991-9a2c-6260f1bbcc2c23
197845ISOtretinoin 40 MG Oral CapsulePSNb2cb63c9-f825-4991-9a2c-6260f1bbcc2c23
404058isotretinoin 10 MG Oral Capsule [Amnesteem]SBDb2cb63c9-f825-4991-9a2c-6260f1bbcc2c23
404061isotretinoin 20 MG Oral Capsule [Amnesteem]SBDb2cb63c9-f825-4991-9a2c-6260f1bbcc2c23
2711694isotretinoin 30 MG Oral Capsule [Amnesteem]SBDb2cb63c9-f825-4991-9a2c-6260f1bbcc2c23
404064isotretinoin 40 MG Oral Capsule [Amnesteem]SBDb2cb63c9-f825-4991-9a2c-6260f1bbcc2c23
197843isotretinoin 10 MG Oral CapsuleSCDb2cb63c9-f825-4991-9a2c-6260f1bbcc2c23
197844isotretinoin 20 MG Oral CapsuleSCDb2cb63c9-f825-4991-9a2c-6260f1bbcc2c23
403930isotretinoin 30 MG Oral CapsuleSCDb2cb63c9-f825-4991-9a2c-6260f1bbcc2c23
197845isotretinoin 40 MG Oral CapsuleSCDb2cb63c9-f825-4991-9a2c-6260f1bbcc2c23
404058Amnesteem 10 MG Oral CapsuleSYb2cb63c9-f825-4991-9a2c-6260f1bbcc2c23
404061Amnesteem 20 MG Oral CapsuleSYb2cb63c9-f825-4991-9a2c-6260f1bbcc2c23
2711694Amnesteem 30 MG Oral CapsuleSYb2cb63c9-f825-4991-9a2c-6260f1bbcc2c23
404064Amnesteem 40 MG Oral CapsuleSYb2cb63c9-f825-4991-9a2c-6260f1bbcc2c23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0378-6613-850037866138510 in 1 BLISTER PACKHistorical
0378-6613-93003786613933 BLISTER PACK in 1 CARTON (0378-6613-93) / 10 CAPSULE in 1 BLISTER PACK (0378-6613-85) 3 blister pack2025-04-10NoNoCurrent