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 243 of 294 · 5,869 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Be Smart Get Prepared Hand SanitizerALCOHOLTotal Resources International, Ince7930ec4-6920-4abb-adce-8cc4de44801d2024-07-02WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLBiocosmetica Excel Argentinaaefcbf7b-3524-9e28-e053-2995a90a5a422024-06-30WarningsExact identifier
unii: 3K9958V90M
Exel Clarifying Line SPF 50OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDEExelencia importers0d6d4098-4121-477e-b404-3ab18628ed682024-06-30WarningsExact identifier
unii: 15FIX9V2JP
Hand SanitizerETHYL ALCOHOLExelencia Importers, Corp.abffec96-20e5-fd78-e053-2a95a90a4b082024-06-30WarningsExact identifier
unii: 3K9958V90M
Maybelline New York Dream Fresh BB Beauty Balm Skin Perfector Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc28c51c59-dbfb-45e5-b536-6e5d5c5560d62024-06-28WarningsExact identifier
unii: 15FIX9V2JP
b pure Hand Sanitizer Lemon ScentedALCOHOLFOURSTAR GROUP USA, INC.3fc74eff-46d6-45f5-bfa5-76a6a923cb942024-06-28WarningsExact identifier
unii: 3K9958V90M
b pure Hand Sanitizer Watermelon ScentedALCOHOLFourstar Group USA, Inc.102d3955-be15-4c1c-b097-c566d675ab7c2024-06-28WarningsExact identifier
unii: 3K9958V90M
LOreal Paris Infallible UP TO 32H Fresh Wear Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Incf6457973-3718-44cd-a764-de0b089d4eee2024-06-28WarningsExact identifier
unii: 15FIX9V2JP
LOreal Paris Visible Lift Serum Absolute Advanced Makeup Broad Spectrum SPF 17 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc8598d56b-adcd-48e8-b6fc-77bc934009c72024-06-27WarningsExact identifier
unii: 15FIX9V2JP
Genuine First Aid Alcohol Cleansing PadBENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.c39c4d80-9718-459f-8ae4-ada043bba5b72024-06-26WarningsExact identifier
unii: 3K9958V90M
IsotretinoinISOTRETINOINMayne Pharma0114567b-3bac-490d-b9eb-03a6c5d909352024-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076485
ndc (package): 68308-782-30
ndc (package): 68308-784-01
ndc (package): 68308-782-01
ndc (package): 68308-781-01
ndc (package): 68308-783-01
ndc (package): 68308-784-30
ndc (package): 68308-783-30
ndc (package): 68308-781-30
ndc (product): 68308-781
ndc (product): 68308-784
ndc (product): 68308-783
ndc (product): 68308-782
ndc11 (package): 68308078401
rxcui: 197844
rxcui: 197845
rxcui: 403930
rxcui: 197843
spl id: 1bcfc61e-1b15-60e8-e063-6294a90ab074
spl set id: 0114567b-3bac-490d-b9eb-03a6c5d90935
unii: EH28UP18IF
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Incbe2a83fb-e4f8-4313-b5bd-150f351fb3452024-06-26WarningsExact identifier
unii: 15FIX9V2JP
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE066a0951-2e7e-40c0-8035-4d708a32f16c2024-06-26WarningsExact identifier
unii: 15FIX9V2JP
b pure Hand Sanitizer Aloe ScentedALCOHOLFOURSTAR GROUP USA, INC.efd7a413-d29b-4b18-97bb-82746376e3df2024-06-25WarningsExact identifier
unii: 3K9958V90M
b pure Hand Sanitizer Eucalyptus ScentedALCOHOLFOURSTAR GROUP USA, INCd154ca37-a28d-48fb-94c8-add632c82bdc2024-06-25WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Gel LeavesALCOHOLBath & Body Works, Inc.1ba7e3fe-d83c-db66-e063-6394a90a3b3a2024-06-25WarningsExact identifier
unii: 3K9958V90M
b pure Hand Sanitizer Shea Butter ScentedALCOHOLFOURSTAR GROUP USA, INC.1eca1353-3422-4e78-96a5-dd4603c04aac2024-06-25WarningsExact identifier
unii: 3K9958V90M
Genuine First Aid Alcohol Cleansing PadISOPROPYL ALCOHOLGFA Production(Xiamen) Co.,Ltdd8842561-f61e-4cac-80d6-001e5369f0d12024-06-25WarningsExact identifier
unii: ND2M416302
Anti Bacterial Hand Gel Raspberries and Whipped VanillaALCOHOLBath & Body Works, Inc.1bbaa102-f43e-a7e8-e063-6394a90a89e82024-06-25WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Mahogany CoconutALCOHOLBath & Body Works, Inc.1bba9390-36ba-20e2-e063-6294a90a4b882024-06-25WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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