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 247 of 294 · 5,869 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Anti Bacterial Hand Gel Calypso ClementineALCOHOLBath & Body Works, Inc.1a25084f-b8d7-1188-e063-6294a90a1e962024-06-05WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Candy Apple CauldronALCOHOLBath & Body Works, Inc.1a251228-7fda-5a38-e063-6294a90a5d082024-06-05WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Champagne Apple and HoneyALCOHOLBath & Body Works, Inc.1a252344-cf76-752e-e063-6294a90a010f2024-06-05WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Chasing DaydreamsALCOHOLBath & Body Works, Inc.1a25aac4-34f8-0371-e063-6294a90ac0822024-06-05WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Coffee and WhiskeyALCOHOLBath & Body Works, Inc.1a25de73-8740-c98d-e063-6394a90afffb2024-06-05WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Crystal Blue CoastALCOHOLBath & Body Works, Inc.1a25f084-5228-b3ef-e063-6294a90a98822024-06-05WarningsExact identifier
unii: 3K9958V90M
toty Solaria BodyOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDECHIPICAN LLC1a121b17-3621-6bc1-e063-6394a90ac9a12024-06-04WarningsExact identifier
unii: 15FIX9V2JP
Anti Bacterial Hand Gel Brightest BloomALCOHOLBath & Body Works, Inc.1a128ecb-230f-0882-e063-6294a90a41372024-06-04WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Brown Sugar Toaster TreatALCOHOLBath & Body Works, Inc.1a12d9ca-fec4-2adc-e063-6394a90ab1812024-06-04WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel ButterflyALCOHOLBath & Body Works, Inc.1a12dbf3-2d95-291c-e063-6394a90a1efd2024-06-04WarningsExact identifier
unii: 3K9958V90M
PROCEUTICALS PRIVATE LABEL by TiZO tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD0b62062d-b77e-4e6c-b3ab-b35ab24db7cb2024-06-04WarningsExact identifier
unii: 15FIX9V2JP
Hand SanitizerALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.dbfdecf0-a961-4cc5-bf87-ae30bbc302dd2024-05-31WarningsExact identifier
unii: 3K9958V90M
hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.19a6c3c6-4b27-9011-e063-6394a90ae5122024-05-30WarningsExact identifier
unii: 3K9958V90M
antibacterial hand sanitizer gel 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.19a7b2fc-239c-b53c-e063-6394a90a09062024-05-30WarningsExact identifier
unii: 3K9958V90M
Protectif Deep TintZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.19b19023-1340-6609-e063-6394a90a6eaf2024-05-30WarningsExact identifier
unii: 15FIX9V2JP
Anti Bacterial Hand Gel Beautiful DayALCOHOLBath & Body Works, Inc.19858fde-3697-1263-e063-6394a90a1c252024-05-28WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Blackberries and BasilALCOHOLBath & Body Works, Inc.19861b01-1595-6863-e063-6294a90a147f2024-05-28WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Blue Raspberry FreezeALCOHOLBath & Body Works, Inc.198654f2-f145-c411-e063-6394a90ae5bb2024-05-28WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Bridgerton StudyALCOHOLBath & Body Works, Inc.19868209-5c8f-2d32-e063-6294a90a82af2024-05-28WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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