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 266 of 289 · 5,777 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDENEWCO LLCfa3c73a3-0dfb-4673-822a-45d946dee2602023-11-06WarningsExact identifier
unii: 15FIX9V2JP
RADIANCE Silky Mineral Primer Sunscreen SPF-42 HONEYTITANIUM DIOXIDE, ZINC OXIDESANTO REMEDIO LLC867a88df-9a18-447f-8301-2ec91566302e2023-11-06WarningsExact identifier
unii: 15FIX9V2JP
KOVR All-Natural SPF-30 Moisturizing Sunscreen for MenTITANIUM DIOXIDE, ZINC OXIDEACTIVE LIFE INCbf766aab-a52d-41e8-a06a-f2e536d2219b2023-11-06WarningsExact identifier
unii: 15FIX9V2JP
PROJECT REEF SPF-50ZINC OXIDE, TITANIUM DIOXIDEProject Reef LLC6bcd470c-6994-4d28-8370-4cc9d68e1e782023-11-06WarningsExact identifier
unii: 15FIX9V2JP
BB OSKIN Broad Spectrum SPF-30TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDEO'Skin Studio NYd84cca38-b673-484e-aa25-df58d904d4d32023-11-06WarningsExact identifier
unii: 15FIX9V2JP
Aruba Aloe Sport Line Lip Balm Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEAruba Aloe Balm NV80461b6d-b1b7-4220-894d-8bd4259094742023-11-06WarningsExact identifier
unii: 15FIX9V2JP
Antibacterial Hand SanitizerETHYL ALCOHOLZhejiang Ayan Biotech Co.,Ltd.51cc4062-a4ef-4504-91a8-4901c4a187802023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.9c56a823-bf7a-3005-e053-2a95a90a22e32023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerETHYL ALCOHOLZhejiang Ayan Biotech Co.,Ltd.c7e94ccb-5ec4-4e35-b8d3-8e1f066f4bb82023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerETHYL ALCOHOLZhejiang Ayan Biotech Co.,Ltd.27dd30e7-3e2c-4409-9cf1-66db27611c1b2023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.9c574647-161d-6459-e053-2995a90a44702023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerETHYL ALCOHOLZhejiang Ayan Biotech Co.,Ltd.075de65e-448f-40e8-b129-7647f923b7832023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.9c56afa2-c06c-fa03-e053-2995a90a74372023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.9c563e53-2246-cd57-e053-2995a90a82d72023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.9c5753a4-f8af-9f09-e053-2995a90ad1382023-11-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.a29c47b9-1a99-5272-e053-2a95a90af4f62023-11-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.50ac080f-ae60-49dd-a01f-7b9bd8ea73a82023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLProstock LLCa185a4b0-a5d3-2487-e053-2995a90a01d32023-11-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERLS PROMOTIONS INC.3f8cae4e-a017-4db6-9a29-ebae65bba34c2023-11-06WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLProstock LLC1f4833c5-fcac-4c01-a5c6-e72837ca0a482023-11-06WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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