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 245 of 294 · 5,869 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Wisteria GardenALCOHOLBath & Body Works, Inc.1ba69e52-2b70-6d06-e063-6394a90a69232024-06-24WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Turquoise WatersALCOHOLBath & Body Works, Inc.1ba6982d-6822-50ed-e063-6394a90a6ac92024-06-24WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Vampire BloodALCOHOLBath & Body Works, Inc.1ba67404-fecc-b089-e063-6394a90a20d92024-06-24WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Wildberry French ToastALCOHOLBath & Body Works, Inc.1ba6a663-9590-4f80-e063-6294a90ac1dd2024-06-24WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Lavender and VanillaALCOHOLBath & Body Works, Inc.1ba6a8d8-b081-bd38-e063-6294a90a44c22024-06-24WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Champagne ToastALCOHOLBath & Body Works, Inc.1ba6a544-2748-68ff-e063-6394a90a63c32024-06-24WarningsExact identifier
unii: 3K9958V90M
STAYKLEARALCOHOLeHealth Nexus LLCc8b31580-5672-61de-e053-2995a90a3e782024-06-24WarningsExact identifier
unii: 3K9958V90M
b pure Hydrating Hand Sanitizer Vanilla Sugar Cookie ScentedALCOHOLFOURSTAR GROUP USA, INC.162a9382-134f-42c1-8961-bcb281be282c2024-06-24WarningsExact identifier
unii: 3K9958V90M
b pure Hydrating Hand Sanitizer Frosted Coconut ScentedALCOHOLFOURSTAR GROUP USA, INC.dd57d7fa-deb3-4b02-a9cc-a39153afa0492024-06-24WarningsExact identifier
unii: 3K9958V90M
Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 30 Sunscreen Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE66a91768-6012-485a-b569-a293ea6d48802024-06-24WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 30 Sunscreen Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc43539766-2e70-4b42-b64b-1d30367b2eb92024-06-24WarningsExact identifier
unii: 15FIX9V2JP
Exel Clarifying Line SPF 50OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDEBiocosmetica Exel Argentina SRLe65a68f6-d1b7-4cbf-a3f8-5cc04036221a2024-06-23WarningsExact identifier
unii: 15FIX9V2JP
Anti Bacterial Hand Gel Love Always WinsALCOHOLBath & Body Works, Inc.1b6a8105-53d2-8e0f-e063-6394a90a64af2024-06-21WarningsExact identifier
unii: 3K9958V90M
ABREVA Rapid Pain ReliefGLYCERIN, LIDOCAINEHaleon US Holdings LLC65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d2024-06-20WarningsExact identifier
unii: PDC6A3C0OX
Anti Bacterial Hand Gel Kitchen MandarinALCOHOLBath & Body Works, Inc.1b2e5934-5914-2060-e063-6394a90ae0d32024-06-18WarningsExact identifier
unii: 3K9958V90M
Protectif Fair TintZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.1a8c8804-1d6b-b5a5-e063-6394a90a12602024-06-18WarningsExact identifier
unii: 15FIX9V2JP
Anti Bacterial Hand Gel Island MargaritaALCOHOLBath & Body Works, Inc.1ac7101d-bef1-7db6-e063-6294a90aca922024-06-13WarningsExact identifier
unii: 3K9958V90M
Protectif UntintedZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.1acd3f09-87f2-75e4-e063-6394a90a0cd92024-06-13WarningsExact identifier
unii: 15FIX9V2JP
MegaBabe Butt Stuff HemorrhoidalCOCOA BUTTER, GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDEMEGABABE, LLC01c156ff-69f9-4d5e-a9ea-abbc52d4afff2024-06-12WarningsExact identifier
unii: PDC6A3C0OX
Anti Bacterial Hand Gel Gingham UnstoppableALCOHOLBath & Body Works, Inc.1ab80018-e9c2-a8eb-e063-6394a90a97f72024-06-12WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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