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 289 of 289 · 5,777 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol WipesALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.14dbe9dc-2504-4181-9565-5fa7c1a9c3772017-10-09WarningsExact identifier
unii: 3K9958V90M
Freeman Packaging Hand SanitizerALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.9827418a-3ab6-447b-8f8a-9eacb56d3a892017-10-09WarningsExact identifier
unii: 3K9958V90M
ONID WipeETHANOLONID Technology Corp83d8b8b6-6257-4553-9441-901bb02c3d602017-06-28Exact identifier
unii: 3K9958V90M
FIND BICHON CLEANSING MASKGLYCERINPioom Cosmetic Co.,ltd50b7db48-7b55-6df4-e054-00144ff88e882017-05-30WarningsExact identifier
unii: PDC6A3C0OX
Age Renewal Firming and Hydrating Moisturizer SPF 30OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDECVS Health5f6f677d-2404-4e56-a48f-4263314afd9b2017-03-14WarningsExact identifier
unii: 15FIX9V2JP
Your Name Cosmetics Brightening CC Cream Broad Spectrum SPF 20YOUR NAME COSMETICS BRIGHTENING CC CREAM BROAD SPECTRUM SPF 20Mana Productsae6a86d2-a95b-4fa8-9676-233ef9fdc3b02017-02-22WarningsExact identifier
unii: 15FIX9V2JP
Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 SunscreenNUANCE SALMA HAYEK RENEWED RADIANCE BRIGHTENING BB CREAM BROAD SPECTRUM SPF 30 SUNSCREENCVS Pharmacy, Inc7795e651-838e-41f8-b48d-bd2e0dd1beec2017-01-18WarningsExact identifier
unii: 15FIX9V2JP
DERMAdoctor DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30DERMADOCTOR DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30Mana Productscec89a7e-1670-4d3c-b48c-28ed1ea7f9572016-12-07WarningsExact identifier
unii: 15FIX9V2JP
Age Renewal FirmingOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAMCOL Health & Beauty Solutions, Inc. DBA6cb27f87-40a3-4049-aded-eb788509c5752016-10-07WarningsExact identifier
unii: 15FIX9V2JP
Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 SunscreenNUANCE SALMA HAYEK RENEWED RADIANCE BRIGHTENING BB CREAM BROAD SPECTRUM SPF 30 SUNSCREENMana Productsd0e00d97-dbf4-46af-aeda-bdfd6f49b5ab2016-09-08WarningsExact identifier
unii: 15FIX9V2JP
Meijer Kids Tear Free SPF 50TITANIUM DIOXIDE, ZINC OXIDEMeijer Distribution, Inc.7415511e-1ecf-4646-b64b-267fbf7d116b2016-06-02WarningsExact identifier
unii: 15FIX9V2JP
Meijer Baby Tear Free SPF 50TITANIUM DIOXIDE, ZINC OXIDEMeijer Distributing Inc.2434de23-bcc9-4a83-9945-16fc3f2b8c612016-06-01WarningsExact identifier
unii: 15FIX9V2JP
TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted)OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.6a996e03-907f-4e6a-b232-0892b86956b02015-08-21WarningsExact identifier
unii: 15FIX9V2JP
CVS Hand SanitizerALCOHOLCVSd0081c50-c0d2-436a-ba83-5d1982ae64b72015-08-17WarningsExact identifier
unii: 3K9958V90M
Renewal Firming Day Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEBURT'S BEES, INC.18ceb5d8-4b76-6a54-e054-00144ff88e882015-06-18WarningsExact identifier
unii: 15FIX9V2JP
Instant Hand SanitizerALCOHOLSafetec of America, Inc.f9e30645-491b-4f54-acfd-f863ee2356072013-08-07WarningsExact identifier
unii: 3K9958V90M
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD.30468afc-9616-4765-b046-12e97a0a78272010-12-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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