NDC 55111-135-79 - ZENATANE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
55111-135
Requested NDC
55111-135-79
Package NDCs from labels
55111-135-79, 55111-135-81
Manufacturer
Dr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited FTO-SEZ-Process Unit-02 | Reed-Lane Inc.
Effective date
2025-02-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Isotretinoin Capsules USPDr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited FTO-SEZ-Process Unit-02 | Reed-Lane Inc.2025-02-07HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-05-02Indexing - Billing Unit

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 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 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 127 · 2,533 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
ISOTRETINOINISOTRETINOINAurobindo Pharma Limited4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e62026-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197844
rxcui: 197845
rxcui: 403930
rxcui: 197843
unii: EH28UP18IF
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
IsotretinoinISOTRETINOINAmneal Pharmaceuticals LLCc2917c3d-3499-48a0-ba53-120cb979195d2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197844
rxcui: 197845
rxcui: 403930
rxcui: 197843
unii: EH28UP18IF
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Smelling SaltsAMMONIAShenzhen Finona Information Technology Co., Ltd3874ec89-0f1d-87b9-e063-6394a90a300a2026-08-24WarningsExact identifier
unii: 5138Q19F1X
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
IsotretinoinISOTRETINOINZydus Pharmaceuticals USA Inc.31f62a49-4c6d-4ce3-a0ca-d159562370b12026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197844
rxcui: 197845
rxcui: 403930
rxcui: 197843
unii: EH28UP18IF
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSHodayfa Abu Alkian524e002c-f509-9395-e063-6394a90acd9e2026-08-20WarningsExact identifier
unii: 5138Q19F1X
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.