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 35 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
B-Pure Moisturizing Hand Sanitizer Midnight Freesia ScentedALCOHOLFourstar Group USA, Inc.e145d190-5290-47d9-9961-e35f746e6b5a2026-05-28WarningsExact identifier
unii: 3K9958V90M
Alcohol Cleansing WipeALCOHOLHubei Fanjian Medical Product Co.,Ltdf278a911-ac4e-6868-e053-2a95a90a2ee32026-05-28WarningsExact identifier
unii: 3K9958V90M
Insect Sting ReliefBENZOCAINE, ALCOHOLHubei Fanjian Medical Product Co.,Ltdf30401c1-961e-44dd-e053-2a95a90a69d62026-05-28WarningsExact identifier
unii: 3K9958V90M
Peep ClubGLYCERINPeep Club Eyecare Corp.513d1988-2827-28d8-e063-6294a90a8d1f2026-05-28WarningsExact identifier
unii: PDC6A3C0OX
Ashley Belle Moisturizing Hand Sanitizer Warm DriftwoodALCOHOLMy Imports Usa, LLCb8457e01-e95f-4507-ac83-3c537c4677392026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer White MuskALCOHOLMy Imports Usa, LLCee41e0d2-7109-4423-82db-2c751de6a5d82026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Caramel CinnamonALCOHOLMy Imports Usa, LLCa77a074b-662a-4d40-a73e-6fe215d2c22f2026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Bergamot WaterALCOHOLMy Imports Usa, LLC4e709d1b-b902-4c40-b156-70b3e0f31cc22026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Tropical MelonALCOHOLMy Imports Usa, LLCb12baf08-4a3d-4e5a-9720-a9d2174a01242026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Champagne AppleALCOHOLMy Imports Usa, LLC84b2359f-3446-4b2a-abc5-6503209bc06f2026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Sunset AmberALCOHOLMy Imports Usa, LLC004452a0-7e99-4487-8311-6e428e3c0f262026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Honey Fresh BloomALCOHOLMy Imports Usa, LLC3a64b15c-c8dc-471c-9e2e-b144d9e13cc52026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Soft CottonALCOHOLMy Imports Usa, LLCadd6c1a8-5ae7-4350-b4f5-e5222db854b12026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Sweet Mint SplashALCOHOLMy Imports Usa, LLC1d1b0435-f6d8-4fe2-83f0-b6943ce924f82026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Raspberry LemonadeALCOHOLMy Imports Usa, LLC9a052668-16cb-4d8e-9964-84d1516baed32026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Golden Honey CitrusALCOHOLMy Imports Usa, LLC66788240-f39b-455f-9aee-08715dbe0eab2026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Sugared CoconutALCOHOLMy Imports Usa, LLC2d52e9de-e850-4842-899e-1f8cc721154d2026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Berry PunchALCOHOLMy Imports Usa, LLCd89cafbe-fdc4-4789-a469-4e705a32208f2026-05-28WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer E3 GelALCOHOLGOJO Industries, LLC52d04540-b14b-8c88-e063-6394a90afd392026-05-27WarningsExact identifier
unii: 3K9958V90M
Rio Glow Hand SanitizerETHYL ALCOHOLPEACH LAYNE, LLC52275eda-9964-0f51-e063-6294a90ad88c2026-05-26WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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