FDA.reportPublic FDA data

ZENATANE

Product NDC
55111-135
11-digit product format
551110135
Labeler code
55111
Product ID
55111-135_d7d883f9-7d20-2c50-8023-e661b46dcd5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ISOTRETINOIN
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA202099
Marketing category
ANDA
Marketing start
2013-03-26
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
ZENATANE
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, 1373333, 1373335, 1373337, 1605088

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
55111-135-79ZENATANE10 in 1 BLISTER PACKCAPSULE, GELATIN COATED1027
55111-135-81ZENATANE3 in 1 CARTONCAPSULE, GELATIN COATED327

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-135-79EA - Each55111-1353156f59f-7cca-46c4-88b2-e970e654094012013-05-02
55111-135-81EA - Each55111-135b8bfb80a-097c-4ed9-8d75-2e558f628e3812013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOTRETINOINACTIVE INGREDIENTEH28UP18IFZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
ISOTRETINOINACTIVE MOIETYEH28UP18IFZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
GELATININACTIVE INGREDIENT2G86QN327LZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
GLYCERININACTIVE INGREDIENTPDC6A3C0OXZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
HYDROGENATED SOYBEAN OILINACTIVE INGREDIENTA2M91M918CZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
SHELLACINACTIVE INGREDIENT46N107B71OZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
SOYBEAN OILINACTIVE INGREDIENT241ATL177AZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-135ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]27Current NDC, Legacy NDC, 2 package rows20250210_27b3cf26-f22e-5b70-1c24-009933b7c6ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197843ISOtretinoin 10 MG Oral CapsulePSN27b3cf26-f22e-5b70-1c24-009933b7c6ee27
197844ISOtretinoin 20 MG Oral CapsulePSN27b3cf26-f22e-5b70-1c24-009933b7c6ee27
403930ISOtretinoin 30 MG Oral CapsulePSN27b3cf26-f22e-5b70-1c24-009933b7c6ee27
197845ISOtretinoin 40 MG Oral CapsulePSN27b3cf26-f22e-5b70-1c24-009933b7c6ee27
1373333ZENATANE 10 MG Oral CapsulePSN27b3cf26-f22e-5b70-1c24-009933b7c6ee27
1373335ZENATANE 20 MG Oral CapsulePSN27b3cf26-f22e-5b70-1c24-009933b7c6ee27
1605088ZENATANE 30 MG Oral CapsulePSN27b3cf26-f22e-5b70-1c24-009933b7c6ee27
1373337ZENATANE 40 MG Oral CapsulePSN27b3cf26-f22e-5b70-1c24-009933b7c6ee27
1373333isotretinoin 10 MG Oral Capsule [Zenatane]SBD27b3cf26-f22e-5b70-1c24-009933b7c6ee27
1373335isotretinoin 20 MG Oral Capsule [Zenatane]SBD27b3cf26-f22e-5b70-1c24-009933b7c6ee27
1605088isotretinoin 30 MG Oral Capsule [Zenatane]SBD27b3cf26-f22e-5b70-1c24-009933b7c6ee27
1373337isotretinoin 40 MG Oral Capsule [Zenatane]SBD27b3cf26-f22e-5b70-1c24-009933b7c6ee27
197843isotretinoin 10 MG Oral CapsuleSCD27b3cf26-f22e-5b70-1c24-009933b7c6ee27
197844isotretinoin 20 MG Oral CapsuleSCD27b3cf26-f22e-5b70-1c24-009933b7c6ee27
403930isotretinoin 30 MG Oral CapsuleSCD27b3cf26-f22e-5b70-1c24-009933b7c6ee27
197845isotretinoin 40 MG Oral CapsuleSCD27b3cf26-f22e-5b70-1c24-009933b7c6ee27
1373333Zenatane 10 MG Oral CapsuleSY27b3cf26-f22e-5b70-1c24-009933b7c6ee27
1373335Zenatane 20 MG Oral CapsuleSY27b3cf26-f22e-5b70-1c24-009933b7c6ee27
1605088Zenatane 30 MG Oral CapsuleSY27b3cf26-f22e-5b70-1c24-009933b7c6ee27
1373337Zenatane 40 MG Oral CapsuleSY27b3cf26-f22e-5b70-1c24-009933b7c6ee27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-135-795511101357910 in 1 BLISTER PACKHistorical
55111-135-81551110135813 BLISTER PACK in 1 CARTON (55111-135-81) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-135-79) 3 blister pack2013-03-260000-00-00NoNoCurrent