FDA.reportPublic FDA data

NDC 68308-784-01 - Isotretinoin

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
68308-784
Requested NDC
68308-784-01
Package NDCs from labels
68308-784-01, 68308-784-30
Manufacturer
Mayne Pharma
Effective date
2024-06-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Isotretinoin - Mayne PharmaMayne Pharma2024-06-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68308-784-01Isotretinoin10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED104
68308-784-30Isotretinoin3 in 1 BOXCAPSULE, LIQUID FILLED34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68308-784ISOTRETINOIN CAPSULE, LIQUID FILLED [MAYNE PHARMA]4Current NDC, 2 package rows20240628_0114567b-3bac-490d-b9eb-03a6c5d90935.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68308-784-01EA - Each68308-784462faae8-2883-4ab8-904e-aad7aa61654212024-01-04
68308-784-30EA - Each68308-784a238822f-acae-4f2f-8696-c46354a4b72d12024-01-04

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 275 of 289 · 5,777 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PUMPKIN SPICE SCENTED CLIP ON HAND SANITIZERALCOHOLFourstar Group USA, Inc.7b099ca8-3045-416d-86f0-36885a280b622023-10-26WarningsExact identifier
unii: 3K9958V90M
Lavender Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.f87f4df2-a595-45e7-b1d0-8f0247c270932023-10-26WarningsExact identifier
unii: 3K9958V90M
Jasmine Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.a1d07799-1b5d-464f-bfe3-3779706375d82023-10-26WarningsExact identifier
unii: 3K9958V90M
Rose Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.b986a0e8-aadf-44dd-a1a8-dcea7c1e66b52023-10-26WarningsExact identifier
unii: 3K9958V90M
Zeyco Antiseptic Hand Sanitizer GelALCOHOLLaboratorios Zeyco, S.A. de C.V.a85df538-dedd-7617-e053-2995a90a4a362023-10-26WarningsExact identifier
unii: 3K9958V90M
Antiseptic Hand SanitizerALCOHOLLaboratorios Zeyco, S.A. de C.V.ad14b387-e280-8dab-e053-2995a90a590c2023-10-26WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLLaboratorios Zeyco, S.A. de C.V.a58cf759-0485-6740-e053-2a95a90a8b432023-10-26WarningsExact identifier
unii: 3K9958V90M
Family WellnessGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, PETROLATUMFRONT PHARMACEUTICAL PLCeb1785f4-5876-443b-b175-9b59d65d1a482023-10-26WarningsExact identifier
unii: PDC6A3C0OX
Zeyco Hand SanitizerALCOHOLLaboratorios Zeyco, S.A. de C.V.aa073f96-5774-c12f-e053-2a95a90aec222023-10-26WarningsExact identifier
unii: 3K9958V90M
Monarch Hand SanitizerALCOHOLLaboratorios Zeyco, S.A. de C.V.aa920f62-352c-4c67-9575-e78f12edef842023-10-26WarningsExact identifier
unii: 3K9958V90M
CVS Health Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMFRONT PHARMACEUTICAL PLCcb448d78-553c-4e65-80c5-d4b31d7b36612023-10-26WarningsExact identifier
unii: PDC6A3C0OX
INSTANT FREE HAND SANITIZERALCOHOLTravel Retail Global Inca3ffa72b-b7d4-463a-a880-66081f16bd1a2023-10-26WarningsExact identifier
unii: 3K9958V90M
SIMPLE TRUTH MINERAL BASED SPF 50 SUNSCREENTITANIUM DIOXIDE, ZINC OXIDETHE KROGER COMPANYa52872bf-cd0f-06da-e053-2995a90af28d2023-10-26WarningsExact identifier
unii: 15FIX9V2JP
PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45TITANIUM DIOXIDE AND ZINC OXIDEESTEE LAUDER INCe87c4a76-5f21-4989-a1e0-0b7c6902f2012023-10-26WarningsExact identifier
unii: 15FIX9V2JP
Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 40TITANIUM DIOXIDE, ZINC OXIDENATURA BISSE INTERNATIONAL SAbf8b71c7-257b-0eb6-e053-2a95a90a3a4c2023-10-26WarningsExact identifier
unii: 15FIX9V2JP
Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCardinal Health 110, LLC. dba Leader85a51d5c-679e-1959-e053-2a91aa0a76d52023-10-25WarningsExact identifier
unii: PDC6A3C0OX
Justice Berry Scented Anti-bacterial Hand SanitizerALCOHOLTween Brands, Inc.8a465ff2-5cb5-43bc-a9a7-d4e2162ac90d2023-10-25WarningsExact identifier
unii: 3K9958V90M
Justice 198824 You Rock Antibacterial Cotton Candy Blueberry Hand SanitizerALCOHOLTween Brands,Inc.84c4fb4b-9f63-4414-b8f3-39f65212f22a2023-10-25WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLBath Concept Cosmetics (Dongguan) Co., Ltd065e083f-3c13-495d-8619-df45c5fce68b2023-10-25WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLIn Designs Global LLCa2dcedcd-e071-176e-e053-2a95a90a176b2023-10-25WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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