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 61 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-BacterialHandSpray Twisted PeppermintALCOHOLBath & Body Works, Inc.463f5b3a-d693-869c-e063-6394a90ac8d02026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Spring AppleALCOHOLBath & Body Works, Inc.463fcad3-0c5c-599f-e063-6394a90a8d212026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pink Peach BlossomALCOHOLBath & Body Works, Inc.4650bac0-c64a-f595-e063-6294a90abdf22026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Gingerbread BakeryALCOHOLBath & Body Works, Inc.4690a48e-b80e-cafc-e063-6394a90aa6a12026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Cinnamon Sugar Pretzel CookieALCOHOLBath & Body Works, Inc.4691401f-e697-898a-e063-6394a90a8d322026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel To The MoonALCOHOLBath & Body Works, Inc.46914e57-f085-e6cd-e063-6294a90a6fc42026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Winter Candy AppleALCOHOLBath & Body Works, Inc.463f7ab4-e5f3-ab23-e063-6394a90a541b2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Marshmallow Pumpkin LatteALCOHOLBath & Body Works, Inc.4650a56b-c159-b228-e063-6394a90a5a6e2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Bright Christmas MorningALCOHOLBath & Body Works, Inc.4650bf54-c759-f503-e063-6294a90a1d2e2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Cookie Butter TruffleALCOHOLBath & Body Works, Inc.468c92f6-9cae-0c6e-e063-6394a90a78ef2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Mrs. Claus CocktailALCOHOLBath & Body Works, Inc.468c93d1-8265-7cd2-e063-6294a90a57762026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Fresh Sparkling SnowALCOHOLBath & Body Works, Inc.468c9682-6163-830f-e063-6294a90a76a92026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray White Tea and SageALCOHOLBath & Body Works, Inc.463fc2a9-742a-fbd3-e063-6394a90a0bf92026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Twisted PeppermintALCOHOLBath & Body Works, Inc.4650b8b0-87be-8c88-e063-6394a90a52ed2026-03-10WarningsExact identifier
unii: 3K9958V90M
Isopropyl alcoholISOPROPYL ALCOHOLSalado Sales Inc.30294cad-d806-4d5b-8c86-484f22d214b62026-03-10Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Anti Bacterial Hand Gel Cereal Milk Soft ServeALCOHOLBath & Body Works, Inc.469140f3-24ed-88e5-e063-6394a90a2f512026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Peppermint Bark TruffleALCOHOLBath & Body Works, Inc.469149e2-656a-cb52-e063-6294a90ad50c2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pumpkin AppleALCOHOLBath & Body Works, Inc.4650ae83-ed71-a7aa-e063-6294a90ad1092026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Fresh RainfallALCOHOLBath & Body Works, Inc.4650bbda-1646-da3a-e063-6294a90a67fa2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Blackberries and BasilALCOHOLBath & Body Works, Inc.4650ab55-8ce4-a5e1-e063-6294a90a79bf2026-03-10WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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