FDA.reportPublic FDA data

Isotretinoin

Product NDC
70771-1558
11-digit product format
707711558
Labeler code
70771
Product ID
70771-1558_b071eb5c-28f7-4b86-b4e9-7c98da2f19df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isotretinoin
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA211568
Marketing category
ANDA
Marketing start
2023-09-12
Substance
ISOTRETINOIN
Active strength
20 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
ISOTRETINOIN20 mg/1

Harmonized Identifiers#

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

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
70771-1558-4Isotretinoin10 in 1 CARTONCAPSULE102
70771-1558-4Isotretinoin10 in 1 BLISTER PACKCAPSULE102
70771-1558-8Isotretinoin10 in 1 BLISTER PACKCAPSULE102
70771-1558-8Isotretinoin3 in 1 CARTONCAPSULE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1558ISOTRETINOIN CAPSULE [ZYDUS LIFESCIENCES LIMITED]2Current NDC, 4 package rows20241201_dae33df0-386c-4db5-9759-7096e770ed17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197843ISOtretinoin 10 MG Oral CapsulePSNdae33df0-386c-4db5-9759-7096e770ed172
197844ISOtretinoin 20 MG Oral CapsulePSNdae33df0-386c-4db5-9759-7096e770ed172
403930ISOtretinoin 30 MG Oral CapsulePSNdae33df0-386c-4db5-9759-7096e770ed172
197845ISOtretinoin 40 MG Oral CapsulePSNdae33df0-386c-4db5-9759-7096e770ed172
197843isotretinoin 10 MG Oral CapsuleSCDdae33df0-386c-4db5-9759-7096e770ed172
197844isotretinoin 20 MG Oral CapsuleSCDdae33df0-386c-4db5-9759-7096e770ed172
403930isotretinoin 30 MG Oral CapsuleSCDdae33df0-386c-4db5-9759-7096e770ed172
197845isotretinoin 40 MG Oral CapsuleSCDdae33df0-386c-4db5-9759-7096e770ed172

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1558-47077115580410 BLISTER PACK in 1 CARTON (70771-1558-4) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2023-09-12NoNoHistorical
70771-1558-8707711558083 BLISTER PACK in 1 CARTON (70771-1558-8) / 10 CAPSULE in 1 BLISTER PACK3 blister pack2023-09-12NoNoHistorical