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 264 of 294 · 5,869 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATTITUDE Super Leaves Hand Sanitizer Olive LeavesETHYL ALCOHOL9055-7588 Quebec Inc. DBA Attitude09d2fef3-00b3-9ee1-e063-6394a90ae3442023-12-11WarningsExact identifier
unii: 3K9958V90M
antiseptic hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.e9f9b7b6-fed7-10e1-e053-2a95a90a9aa62023-12-11WarningsExact identifier
unii: 3K9958V90M
HAN-I-SIZEHAN-I-SIZEMomar, Inc.05e1f56d-2ee9-d13f-e063-6294a90afc912023-12-11WarningsExact identifier
unii: 3K9958V90M
INSTANTINSTANTUltra-Chem, Inc.0c425c6e-6c05-1748-e063-6394a90a9b5e2023-12-11WarningsExact identifier
unii: 3K9958V90M
AntiochPharma Hand SanitizerALCOHOLWeeks & Leoa1a0d368-b004-59b8-e053-2995a90ab4b12023-12-11WarningsExact identifier
unii: 3K9958V90M
Vichy Laboratoires Capital Soleil 60 Mineral Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra LightweightTITANIUM DIOXIDELOreal USA Products Inc4692b146-1abe-48e8-b097-ea9c556962b62023-12-11WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin ProtectantGLYCERINL'Oreal USA Products Inc32eaaaab-41bd-4efe-a71d-92e3a702c1e52023-12-11WarningsExact identifier
unii: PDC6A3C0OX
Vichy Laboratoires Capital Soleil 60 Mineral Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra Lightweight SunscreenTITANIUM DIOXIDECosmetique Active Productionacb887bc-7e46-4257-9fe3-a2cade6c4f382023-12-11WarningsExact identifier
unii: 15FIX9V2JP
Family Wellness HEMORRHOIDGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLFAMILY DOLLAR (Family Wellness)16ceb129-5c0a-428a-a867-cfbbb08bb62a2023-12-11WarningsExact identifier
unii: PDC6A3C0OX
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5GLYCERINCosmetique Active Production01c8a0d5-bcd1-4639-be45-530a226401f02023-12-11WarningsExact identifier
unii: PDC6A3C0OX
Erborian BB creme au Ginseng chocolate SPF 20OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lddcd6ea4-e7b1-88df-e053-2a95a90a99232023-12-09WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN - BB CREME AU GINSENG CARAMEL SPF20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L43c81760-6bb6-25fe-e054-00144ff8d46c2023-12-09WarningsExact identifier
unii: 15FIX9V2JP
Erborian CC Dull Correct SPF25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lcb23ba95-1e83-4523-a35c-3b70c0605dd12023-12-09WarningsExact identifier
unii: 15FIX9V2JP
Algonquin HanSanALCOHOLWhisk Products, Inc.1808f5ab-4bee-4768-995b-911b10cfa18b2023-12-08WarningsExact identifier
unii: 3K9958V90M
D-GermALCOHOLWhisk Products, Inc.fe08fb0c-007c-40a7-e053-6294a90acac92023-12-08WarningsExact identifier
unii: 3K9958V90M
Pacific Breeze Instant Hand Sanitizer GelALCOHOLWhisk Products, Inc.3f574300-b05a-4f98-98fa-dd2177bb3d752023-12-08WarningsExact identifier
unii: 3K9958V90M
Pretty Pump Hand SanitizerALCOHOLWhisk Products, Inc.c6d6ca9a-9fe7-4a6d-8179-e085a4b414c82023-12-08WarningsExact identifier
unii: 3K9958V90M
AP HanSanALCOHOLWhiskProducts, Inc.e212fd90-f4e4-44c4-bfb7-16e313c30be92023-12-07WarningsExact identifier
unii: 3K9958V90M
Aire-Master Waterless Hand SanitizerALCOHOLWhisk Products, Inc.8f0b77b1-ef16-4a3c-874b-07f78d6a45b72023-12-07WarningsExact identifier
unii: 3K9958V90M
Cetaphil Sheer Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.ac2d5713-9955-477e-a10f-e8a1191b5fdd2023-12-07WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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