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 274 of 289 · 5,777 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
P b pure Antibacterial Hand Sanitizer Ocean Breeze ScentedALCOHOLFOURSTAR GROUP USA, INC.b17d3da6-a0f8-55d2-e053-2995a90a6ab92023-10-26WarningsExact identifier
unii: 3K9958V90M
P b pure Antibacterial Hand Sanitizer Cucumber Melon ScentedALCOHOLFOURSTAR GROUP USA, INC.b17d5660-8514-b1dc-e053-2a95a90a0ac82023-10-26WarningsExact identifier
unii: 3K9958V90M
Fresh Peach Scented Antibacterial Hand SanitizerALCOHOLFourstar Group USA, Inc.b3390527-82af-612d-e053-2995a90aafd92023-10-26WarningsExact identifier
unii: 3K9958V90M
Sweet Pea Scented Antibacterial Hand SanitizerALCOHOLFourstar Group USA, Inc.b33937e3-1a55-f020-e053-2a95a90a86572023-10-26WarningsExact identifier
unii: 3K9958V90M
Cucumber Melon Scented Antibacterial Hand SanitizerALCOHOLFourstar Group USA, Inc.b338dd92-0ace-2c9d-e053-2995a90a63ca2023-10-26WarningsExact identifier
unii: 3K9958V90M
P b pure Antibacterial Hand Sanitizer Sweet Pea ScentedALCOHOLFOURSTAR GROUP USA, INC.b17d7c7c-c354-4554-e053-2a95a90a9e842023-10-26WarningsExact identifier
unii: 3K9958V90M
Ocean Breeze Scented Antibacterial Hand SanitizerALCOHOLFourstar Group USA, Inc.b3391b8e-877f-e74a-e053-2995a90afd622023-10-26WarningsExact identifier
unii: 3K9958V90M
Lavender scented anti-bacterial hand sanitizerALCOHOLFOURSTAR GROUP USA, INC.c54e85c6-3c3a-5c53-e053-2995a90ab7592023-10-26WarningsExact identifier
unii: 3K9958V90M
Coconut and Lime Scented Hand SanitizerALCOHOLFOURSTAR GROUP USA, INC.c090752c-8a03-e19b-e053-2995a90a73702023-10-26WarningsExact identifier
unii: 3K9958V90M
Cucumber and Melon Scented Hand SanitizerALCOHOLFOURSTAR GROUP USA, INC.c090c632-ecae-3c13-e053-2995a90a130d2023-10-26WarningsExact identifier
unii: 3K9958V90M
Aloe scented anti-bacterial hand sanitizerALCOHOLFOURSTAR GROUP USA, INC.c55d0287-ff05-82dd-e053-2995a90af78f2023-10-26WarningsExact identifier
unii: 3K9958V90M
Rose scented anti-bacterial hand sanitizerALCOHOLFOURSTAR GROUP USA, INC.c55d3036-1d0d-0cbf-e053-2995a90a1e042023-10-26WarningsExact identifier
unii: 3K9958V90M
Pomegranate and Vanilla Scented Hand SanitizerALCOHOLFOURSTAR GROUP USA, INC.c09137da-36ac-7fcf-e053-2a95a90a63962023-10-26WarningsExact identifier
unii: 3K9958V90M
Jasmine scented anti-bacterial hand sanitizerALCOHOLFOURSTAR GROUP USA, INC.c55e09b0-c61f-3037-e053-2995a90a72e22023-10-26WarningsExact identifier
unii: 3K9958V90M
CHERRY BLOSSOM SCENTED HAND SANITIZERALCOHOLFourstar Group USA, Inc.06e7d79d-6c12-45db-8da4-96f8505966bd2023-10-26WarningsExact identifier
unii: 3K9958V90M
BERRY SCENTED CLIP ON HAND SANITIZERALCOHOLFourstar Group USA, Inc.87887e2c-dde0-4753-8f7a-2747a1ff2a9d2023-10-26WarningsExact identifier
unii: 3K9958V90M
CHAI LATTE SCENTED HAND SANITIZERALCOHOLFourstar Group USA, Inc.4925eaed-f427-44dd-a456-d00aaec6a0322023-10-26WarningsExact identifier
unii: 3K9958V90M
CHAI LATTE SCENTED CLIP ON HAND SANITIZERALCOHOLFourstar Group USA, Inc.144d694a-b807-44fe-af13-91b8de1605812023-10-26WarningsExact identifier
unii: 3K9958V90M
PUMPKIN SPICE SCENTED HAND SANITIZERALCOHOLFourstar Group USA, Inc.f4de93d9-ac50-45af-aacd-62c7b325ce1c2023-10-26WarningsExact identifier
unii: 3K9958V90M
Aloe Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.d641ac0d-c25b-4727-b7da-107cdc3312af2023-10-26WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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