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 75 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BCBG GENERATION HAND SANITIZER ORANGE BLOSSOM SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO432d32fa-e3d3-4740-94f0-4a828ef5bc232026-02-13WarningsExact identifier
unii: 3K9958V90M
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
IsotretinoinISOTRETINOINUpsher-Smith Laboratories, LLC08529687-26b2-41e5-b6fb-35b4c0d891fe2026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197844
rxcui: 403930
rxcui: 197843
unii: EH28UP18IF
CalamineCALAMINE, PRAMOXINE HCLTopco Associates LLC15d1ae3f-509c-4e6b-8f0c-cf92656803582026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
AdvancedETHYL ALCOHOLTopco Associates LLCfaaa3452-ef1e-47db-9978-5105de69d9812026-02-13Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLTopco Associates LLC686dd9a1-13db-4a2b-ba04-492d14e81b562026-02-13Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerALCOHOLWakefern Food Corp.9859ef63-70a7-4986-ad22-0c1c7333c6cb2026-02-13WarningsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerALCOHOLWakefern Food Corp.c441a053-d241-48b4-a33b-971b890f27402026-02-13Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLWakefern Food Corp.c5dd2b25-9003-4c4b-8a86-ecf186695ce32026-02-13Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
IsotretinoinISOTRETINOINUpsher-Smith Laboratories, LLCc369e1c3-90c5-4768-9741-56c62253a2c42026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076485
rxcui: 197844
rxcui: 197845
rxcui: 403930
rxcui: 197843
unii: EH28UP18IF
BCBG GENERATION HAND SANITIZER BERGAMOT SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOfaba4dec-67dc-4db0-a48b-e39b3edf2f992026-02-13WarningsExact identifier
unii: 3K9958V90M
Smart Care VANILLA HEAVEN HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.43c129d8-0ad3-4630-acd9-b604cbda36e02026-02-13WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLWinCo Foods, LLC5f5ee353-2387-4b15-af39-5bbe3fda4dc42026-02-12Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLWinco Foods25204aac-e940-45dc-804b-81fd141449d72026-02-12Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLWalgreen Co.1e879904-055e-4bec-a504-3c783fc9fb242026-02-12Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
unii: PDC6A3C0OX
Spectrum Hand SanitizerETHYL ALCOHOLMedline Industries, LP70598373-bc89-07b9-e053-2991aa0a9e9a2026-02-11WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLMedline Industries, LPf84f7050-348d-4f75-ab93-e618ff8de7902026-02-11WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLMedline Industries, LP42813b3e-dfae-495c-bffb-bf3862857cb12026-02-11WarningsExact identifier
unii: 3K9958V90M
Spectrum 62% Hand SanitizerETHYL ALCOHOLMedline Industries, LP6971b7de-039d-292f-e053-2a91aa0a26b22026-02-11WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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