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 45 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEGPNY CORP211dea04-faad-8ffc-e063-6294a90a8d682026-04-29WarningsExact identifier
unii: 15FIX9V2JP
B-Pure Moisturizing Hand Sanitizer Vanilla Creme ScentedALCOHOLFourstar Group USA, Inc.13faded0-7953-4d86-b952-e4bcf4ba53cc2026-04-28WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Sweet Plum and Jasmine ScentedALCOHOLFourstar Group USA, Inc.450d025a-cc11-796e-e063-6394a90a7e5c2026-04-28WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Coconut Vanilla ScentedALCOHOLFourstar Group USA, Inc.e179b21d-fb93-4671-87c0-b8ae094533282026-04-28WarningsExact identifier
unii: 3K9958V90M
Anything SPFOCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDEAnything SPF LLC508b8dcb-6600-6dad-e063-6294a90a565a2026-04-28WarningsExact identifier
unii: 15FIX9V2JP
Scriptsusa Hand SanitizerALCOHOLEnergized Solution Corp4f97edd9-717a-315b-e063-6394a90aade72026-04-27WarningsExact identifier
unii: 3K9958V90M
Alcohol wet wipesALCOHOL WET WIPESShandong Aishule Hygiene Products Co., Ltdf79dbac0-cec0-46bc-e053-6294a90a2b132026-04-25WarningsExact identifier
unii: 3K9958V90M
Wet wipesWET WIPESJINGXIN GROUP (M) SDN BHD395225b1-486b-1867-e063-6394a90a18652026-04-25WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLMerchSource, LLC5054a055-50d0-f12a-e063-6294a90ad78e2026-04-25WarningsExact identifier
unii: 3K9958V90M
REFRESH TEARS PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.9e1cba7b-84ed-47f3-b19a-1219928343502026-04-24WarningsExact identifier
unii: PDC6A3C0OX
Ethyl AlcoholETHYL ALCOHOLUpLift Brands, LLC5035ec52-2d65-cbbf-e063-6294a90a4a5c2026-04-24Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Foaming Sanitizing HandALCOHOLKutol Products Companyb2e22e51-88f5-4391-8705-3855c1645d802026-04-24WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Amber Breeze ScentedALCOHOLFourstar Group USA, Inc.eb39678d-7576-4147-be02-b7779a5758282026-04-24WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Kick Off ScentedALCOHOLFourstar Group USA, Inc.860f25c3-54b0-4438-ba97-0fc81cf350442026-04-24WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON HAND SANITIZER Island Coco ScentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO9e4d9add-0a02-4cce-91e0-7c3ce3ad5cb22026-04-23WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON HAND SANITIZER Sugar Lemon ScentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCObaa5166d-e41f-46aa-adae-038f444bb54e2026-04-23WarningsExact identifier
unii: 3K9958V90M
3M DuraPrep SurgicalIODINE POVACRYLEX AND ISOPROPYL ALCOHOLSolventum US LLC22a10a54-6a04-48b3-9ec4-b26526183daf2026-04-23WarningsExact identifier
unii: ND2M416302
FRESH FEELS HAND SANITIZER MIST LAVENDER SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited8efafedf-a66e-44a3-b2af-700292f1d0012026-04-23WarningsExact identifier
unii: 3K9958V90M
3M SoluPrep SCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLSolventum US LLC084aa305-5863-441a-a94d-36bc1b05195a2026-04-23WarningsExact identifier
unii: ND2M416302
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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