FDA.reportPublic FDA data

Isotretinoin

Product NDC
57664-020
11-digit product format
576640020
Labeler code
57664
Product ID
57664-020_0e924cf6-5375-28c4-e063-6294a90a4ac4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isotretinoin
Dosage form
CAPSULE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA021951
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-12-29
Substance
ISOTRETINOIN
Active strength
10 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
Isotretinoin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOTRETINOIN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEH28UP18IF
Rxcui197843, 197844, 197845, 403930, 1547561, 1547565

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
57664-020-97Isotretinoin3 in 1 BOXCAPSULE32
57664-020-98Isotretinoin10 in 1 BLISTER PACKCAPSULE102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-020-97EA - Each57664-0209e054472-d958-4183-b550-2c941040596f12021-05-05
57664-020-98EA - Each57664-020f414c3a7-b28c-4791-bc11-647485ae157e12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-020ISOTRETINOIN CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]2Current NDC, Legacy NDC, 2 package rows20240110_b44200ba-6672-4ea7-b151-7caec3f53c9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197843ISOtretinoin 10 MG Oral CapsulePSNb44200ba-6672-4ea7-b151-7caec3f53c9c2
197844ISOtretinoin 20 MG Oral CapsulePSNb44200ba-6672-4ea7-b151-7caec3f53c9c2
1547561ISOtretinoin 25 MG Oral CapsulePSNb44200ba-6672-4ea7-b151-7caec3f53c9c2
403930ISOtretinoin 30 MG Oral CapsulePSNb44200ba-6672-4ea7-b151-7caec3f53c9c2
1547565ISOtretinoin 35 MG Oral CapsulePSNb44200ba-6672-4ea7-b151-7caec3f53c9c2
197845ISOtretinoin 40 MG Oral CapsulePSNb44200ba-6672-4ea7-b151-7caec3f53c9c2
197843isotretinoin 10 MG Oral CapsuleSCDb44200ba-6672-4ea7-b151-7caec3f53c9c2
197844isotretinoin 20 MG Oral CapsuleSCDb44200ba-6672-4ea7-b151-7caec3f53c9c2
1547561isotretinoin 25 MG Oral CapsuleSCDb44200ba-6672-4ea7-b151-7caec3f53c9c2
403930isotretinoin 30 MG Oral CapsuleSCDb44200ba-6672-4ea7-b151-7caec3f53c9c2
1547565isotretinoin 35 MG Oral CapsuleSCDb44200ba-6672-4ea7-b151-7caec3f53c9c2
197845isotretinoin 40 MG Oral CapsuleSCDb44200ba-6672-4ea7-b151-7caec3f53c9c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-020-97576640020973 BLISTER PACK in 1 BOX (57664-020-97) / 10 CAPSULE in 1 BLISTER PACK (57664-020-98) 3 blister pack2020-12-290000-00-00NoNoCurrent
57664-020-985766400209810 in 1 BLISTER PACKHistorical