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 214 of 294 · 5,869 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
germstarGelETHYL ALCOHOLSoaptronic, LLCb5fd6c3c-d452-74e6-e053-2995a90a90902024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Cucumber MelonALCOHOLBath & Body Works, Inc.29a63c54-116f-30bb-e063-6394a90a8c6f2024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Frosted Coconut SnowballALCOHOLBath & Body Works, Inc.29a652a8-15fd-80d4-e063-6394a90acb4d2024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Black Cherry FrostALCOHOLBath & Body Works, Inc.29a654df-016b-830e-e063-6394a90a10622024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Winterberry IceALCOHOLBath & Body Works, Inc.29a64c95-eb54-8081-e063-6394a90a07262024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Magic In The AirALCOHOLBath & Body Works, Inc.29a651e4-a014-57d2-e063-6394a90a35f02024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sweet Tea and LemonadeALCOHOLBath & Body Works, Inc.29a64de5-af39-5a91-e063-6394a90ac35c2024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Honolulu SunALCOHOLBath & Body Works, Inc.29a64c62-8517-1b39-e063-6294a90a35a82024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Strawberry SnowflakesALCOHOLBath & Body Works, Inc.29a651e4-a016-57d2-e063-6394a90a35f02024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Snowflakes and CashmereALCOHOLBath & Body Works, Inc.29a654df-0169-830e-e063-6394a90a10622024-12-19WarningsExact identifier
unii: 3K9958V90M
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 CARAMELOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29a82ba9-c0f8-0edf-e063-6294a90a50b42024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SABLEOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29a8812b-70ff-e8aa-e063-6294a90a09f82024-12-19WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Neutral DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, AVOBENZONEKW ABSC, INC.3a548deb-3670-4c5b-a139-796701801fed2024-12-19WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Olive Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.be4434c0-cbdd-46cb-8015-4c7859e80d4a2024-12-19WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Golden MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.de50e956-a014-4147-922b-63c95fa6f86b2024-12-19WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Neutral LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.44cbb226-83ed-401b-baf8-ca8e4740dbef2024-12-19WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Neutral Medium LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.615f5e39-695d-41d4-af59-e0d3b76789bb2024-12-19WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Warm DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, AVOBENZONEKW ABSC, INC.6ab3e360-8104-4439-93fb-e11bc4a775582024-12-19WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Neutral MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.a297ff64-678c-4936-8384-022606a2f33c2024-12-19WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Neutral FairTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.aa8176c6-f1c9-43dd-96e0-f7d6ed30a1a22024-12-19WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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