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 85 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Blueberry FreesiaETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48de4a31-c620-6c1c-e063-6394a90abb962026-01-20WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Lemon Sugar BlossomETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48df981a-74da-a629-e063-6294a90a7f402026-01-20WarningsExact identifier
unii: 3K9958V90M
Smart Care COCO CABANA HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.026aff02-33cf-486d-ae7f-0f0913ce83992026-01-20WarningsExact identifier
unii: 3K9958V90M
Walgreens PEAR Hand Sanitizer MistETHYL ALCOHOLWalgreen Co.a89f90e1-0696-4688-9503-5e6b3e7853bd2026-01-20WarningsExact identifier
unii: 3K9958V90M
Smart Care CITRUS SUNSET HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.de33db2f-9329-4c42-b67f-de5358c547aa2026-01-19WarningsExact identifier
unii: 3K9958V90M
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior12edec55-2414-4bbd-bc96-4599a96b96ac2026-01-19WarningsExact identifier
unii: 15FIX9V2JP
OUTER REEF MINERAL SUNSCREEN SPF 30TITANIUM DIOXIDECoral Reef Park Co., Inc.86ee2fdf-8a88-44e6-b12a-36a92360477a2026-01-19WarningsExact identifier
unii: 15FIX9V2JP
IntralipidI.V. FAT EMULSIONProPharma Distribution48c12fbe-c5e8-a1fc-e063-6294a90a15ae2026-01-19Warnings, Adverse reactionsExact identifier
unii: 241ATL177A
Scent Theory Hand Sanitizers Coastal Mist, Boardwalk Treats, Firecracker FreezeALCOHOLScent Theory Products LLC48c3d5e9-2d57-5a46-e063-6394a90a07222026-01-19WarningsExact identifier
unii: 3K9958V90M
Smart Care SWEET AND STILL HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.1086c3cd-5081-49ed-8380-7a7f31488f532026-01-19WarningsExact identifier
unii: 3K9958V90M
CURESHIELD MANICURE SUNSCREENZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD48b4fad7-073d-d983-e063-6394a90ae3142026-01-18WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior65ff0448-17e6-42ce-989a-940794fcbd8c2026-01-17WarningsExact identifier
unii: 15FIX9V2JP
Walgreens WATERMELON Hand Sanitizer MistETHYL ALCOHOLWalgreen Co.08952596-4a48-4792-9d4d-008590c713122026-01-17WarningsExact identifier
unii: 3K9958V90M
Smart Care MORNING DEW HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.7a3915c6-8f40-4c08-a5c1-ea28ed583df72026-01-16WarningsExact identifier
unii: 3K9958V90M
Smart Care ROSEBUD HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.e6d8afb6-7f6c-4093-b4fb-ec66a998273b2026-01-16WarningsExact identifier
unii: 3K9958V90M
Smart Care SEA BREEZE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.d98cddef-e846-4e6f-939b-d854221399f72026-01-16WarningsExact identifier
unii: 3K9958V90M
Smart Care TROPICAL MANGO HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.5f4744c2-da0e-41ca-b5a5-2829cbf0cb1e2026-01-16WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZERHAND SANITIZERGuangdong bangze medicine co., ltd40018618-8f95-f6db-e063-6394a90ac7dd2026-01-16WarningsExact identifier
unii: 3K9958V90M
hi peach layneETHYL ALCOHOLZhejiang Jinghui Cosmetics Share Co., Ltd.487b648a-1680-6de5-e063-6394a90ab8522026-01-16WarningsExact identifier
unii: 3K9958V90M
hi peach layneETHYL ALCOHOLZhejiang Jinghui Cosmetics Share Co., Ltd.487e6851-1ca3-f9db-e063-6394a90a56f12026-01-16WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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