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 180 of 295 · 5,897 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WISH RUBBING ALCOHOL 99% WINTERGREENISOPROPYL ALCOHOLLJ Pharmade7b2253-7f36-4a27-8838-442ec635f69b2025-06-16WarningsExact identifier
unii: ND2M416302
WISH RUBBING ALCOHOL 70% WINTERGREENISOPROPYL ALCOHOLLJ Pharma98ebf7a7-7c13-4feb-90b5-21cc6dab99f62025-06-16WarningsExact identifier
unii: ND2M416302
Smart Care JUICY BERRY HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.8f9feca1-59e9-4be9-9b89-0a615be159ef2025-06-16WarningsExact identifier
unii: 3K9958V90M
Smart Care PISTACHIO BRULE HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.3a88b38c-f754-4756-be73-e1c03fe607302025-06-16WarningsExact identifier
unii: 3K9958V90M
HAND-I-SAN75% ISOPROPYL ALCOHOL HAND SANITIZERZECO, LLC37627a51-cf31-013c-e063-6294a90ae13a2025-06-13WarningsExact identifier
unii: ND2M416302
Lacura Moisturizing Hand SanitizerETHYL ALCOHOL 62%Aldidafa52fe-42e6-2c21-e053-2995a90a413f2025-06-13WarningsExact identifier
unii: 3K9958V90M
RefresherALCOHOLJao Limited1debc8ca-2ea4-40c3-ad1e-8c1dc763d0f82025-06-13WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Sugar Plum ScentedALCOHOLFourstar Group USA, Inc.5a1a58d4-dddf-45f7-a327-b18a6eed44d42025-06-12WarningsExact identifier
unii: 3K9958V90M
Instantly DryTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC37624bf6-4949-1b10-e063-6294a90ac4882025-06-12Exact identifier
unii: 15FIX9V2JP
Smart Care Cucumber Melon HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.cdae74d9-48a7-47dc-b006-8e2b0c2562572025-06-12WarningsExact identifier
unii: 3K9958V90M
Smart Care Sweet Citrus HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.3c1581c6-c615-463e-83ad-cc84391b80e72025-06-12WarningsExact identifier
unii: 3K9958V90M
Reflecting Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEHelande, LLC3750f04b-7f9f-8793-e063-6294a90a91432025-06-11WarningsExact identifier
unii: 15FIX9V2JP
Smart Care Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.371ef8bb-9e3e-e5cc-e063-6394a90a4b6e2025-06-09WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer SpidermanALCOHOLShenzhen Lantern Scicence Co.,Ltd.371f6cbb-0164-e82d-e063-6294a90ae2df2025-06-09WarningsExact identifier
unii: 3K9958V90M
SHISEIDO ULTIMATE SUN PROTECTION STITANIUM DIOXIDE AND ZINC OXIDEShiseido Americas Corporationb2fae1ba-67fe-48ef-b31f-62db343499612025-06-09WarningsExact identifier
unii: 15FIX9V2JP
Smart Care Hand Sanitizer --SquishmallowsALCOHOLShenzhen Lantern Scicence Co.,Ltd.371b5429-a392-02d0-e063-6294a90a7fe82025-06-08WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer TransformerALCOHOLShenzhen Lantern Scicence Co.,Ltd.371c47f6-ba88-4a7c-e063-6294a90a16972025-06-08WarningsExact identifier
unii: 3K9958V90M
Smart Care Passion Fruit HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.0fec6b2c-21ac-44ae-8e84-5e3795fdd5d52025-06-06WarningsExact identifier
unii: 3K9958V90M
Singular Wipes fragrance freeISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLC6026cb8b-4556-41bd-a7b9-d9bb309005c72025-06-06WarningsExact identifier
unii: ND2M416302
Singular WipesALCOHOLSINGULAR ENTERPRISES LLC03957345-ccd0-4def-b528-7733e6a24cbb2025-06-06WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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