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 277 of 289 · 5,777 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd1c9f2c8b-6ed6-4e54-a151-5be4acb290e42023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd878bfaa7-d553-40db-8311-19010930abd92023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltdc1273e40-5c09-435b-adf3-e352fdd01e9e2023-10-23WarningsExact identifier
unii: ND2M416302
Jianerkang Sanitizing WipeALCOHOLJianerkang Medical Co., Ltda49b06b6-568b-05b1-e053-2995a90af1422023-10-23WarningsExact identifier
unii: 3K9958V90M
Jianerkang WipesALCOHOLJianerkang Medical Co., Ltda49afe9a-3eaa-401b-e053-2995a90a92452023-10-23WarningsExact identifier
unii: 3K9958V90M
Alcohol Preps SterileISOPROPYL ALCOHOLJianerkang Medical Co., Ltd65c8f4de-6516-4caa-a458-228b7b4f6f782023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltdc13af96e-f76a-4577-8d57-811ccc6527382023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep Pad 70 Isopropyl AlcoholISOPROPYL ALCOHOLJianerkang Medical Co., Ltdaf84e47f-01d6-d24e-e053-2a95a90a7edd2023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep Pad Non-SterileISOPROPYL ALCOHOLJianerkang Medical Co., Ltd9b835128-194a-4527-abd5-c507ca94b1972023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep Pad SterileISOPROPYL ALCOHOLJianerkang Medical Co., Ltda4d1f759-7f35-d277-e053-2a95a90abc8c2023-10-23WarningsExact identifier
unii: ND2M416302
Instant Hand Sanitizer STERILE 70 Ethyl AlcoholALCOHOLJianerkang Medical Co., Ltdaf854c92-12e9-f608-e053-2a95a90ae8f62023-10-23WarningsExact identifier
unii: 3K9958V90M
Alcohol SwabstickISOPROPYL ALCOHOLJianerkang Medical Co., Ltdb576911b-bbf2-4ce7-a94a-29bbf719f2052023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Swabsticks 1s SterileISOPROPYL ALCOHOLJianerkang Medical Co., Ltdf725587c-ed7b-48de-885a-ac464e72e6d22023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Swabsticks 3s SterileISOPROPYL ALCOHOLJianerkang Medical Co., Ltd6b21e472-d473-4b22-bc31-78b00c523e2d2023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep Pad Medium PadISOPROPYL ALCOHOLHenry Schein Inc.bdd02ae1-782a-dc72-e053-2a95a90a75542023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep Pad Medium PadISOPROPYL ALCOHOLHenry Schein Inc.b46933ab-41f5-7513-e053-2a95a90a0c692023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep Pad Large PadISOPROPYL ALCOHOLHenry Schein Inc.b468eefd-625b-5c27-e053-2995a90ab0f42023-10-23WarningsExact identifier
unii: ND2M416302
Farmasi CC Cream LIGHT to MEDIUM 02TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI28b3fdff-1986-4048-9ed5-a3d784a4014e2023-10-23WarningsExact identifier
unii: 15FIX9V2JP
Farmasi CC Cream- MEDIUM 03TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI65de3c45-8ec2-4d73-8a29-6203d3b47bd72023-10-23WarningsExact identifier
unii: 15FIX9V2JP
Farmasi BB Cream- MEDIUM 03TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI9102aa2f-0308-4985-b8a8-8e105047b61f2023-10-23WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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