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 219 of 294 · 5,869 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Sun-Ripened RaspberryALCOHOLBath & Body Works, Inc.28edbdd5-f542-8409-e063-6394a90afc582024-12-11WarningsExact identifier
unii: 3K9958V90M
ERBORIAN - BB CREME AU GINSENG CLAIR SPF 20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lee9ae84b-c8fc-4a87-8910-46ec8ccfe1a92024-12-11WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN - BB CREME AU GINSENG DORE SPF 20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L121aa873-5ca6-426b-8ece-dcb5a9f82a032024-12-11WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN - CC CREME HIGH DEFINITION SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L3421b9a3-6551-406f-af3a-b3da8a01d2b22024-12-11WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN CC RED CORRECT SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELaboratoires M&L21530925-03b7-40bb-9836-6ee4011c4a792024-12-11WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMELOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L70a5537c-a364-4dae-8ab2-8ca0cbfd11b72024-12-11WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIROCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lb55be8cb-7f21-45b0-bb8f-a60182077ca32024-12-11WarningsExact identifier
unii: 15FIX9V2JP
PURELL Healthcare Advanced Hand Sanitizer GelALCOHOLGOJO Industries, Inc.e3eef311-7515-46e8-8643-ead7905961842024-12-11WarningsExact identifier
unii: 3K9958V90M
Purell Advanced Moisturizing 2in1ALCOHOLGOJO Industries, Inc.950002ed-f3a2-4ede-98fe-762ee9f018b92024-12-11WarningsExact identifier
unii: 3K9958V90M
I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen Deep HoneyZINC OXIDE AND TITANIUM DIOXIDEAllure Labsdc792777-d8b6-3ebc-e053-2a95a90abc3f2024-12-11WarningsExact identifier
unii: 15FIX9V2JP
Optimize Thick Hand SanitizerALCOHOLMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inca35b9348-c35f-7ba9-e053-2995a90a4a302024-12-11WarningsExact identifier
unii: 3K9958V90M
PURELL Healthcare Advanced Hand Sanitizer ULTRA NOURISHING FoamALCOHOLGOJO Industries, Inc.4fa85619-257f-4a19-a8f2-5a2e4b8097262024-12-11WarningsExact identifier
unii: 3K9958V90M
ZOEY naturals Island Hibiscus HAND SANITIZERETHYL ALCOHOLAbsolutely Natural, Inc.2829dec2-1425-4ac3-812b-f45abd7ec4262024-12-11WarningsExact identifier
unii: 3K9958V90M
Absolutely Natural Cherry Blossom Hand SanitizerETHYL ALCOHOLAbsolutely Natural, Inc.f825e0bf-495f-4bfa-a6e0-5ddbefb37f522024-12-11WarningsExact identifier
unii: 3K9958V90M
Absolutely Natural Rosemary and Mint Hand SanitizerETHYL ALCOHOLAbsolutely Natural, Inc.a7be8b58-8f3e-46ed-ae4d-45f093c98dc32024-12-11WarningsExact identifier
unii: 3K9958V90M
ZOEY naturals English Garden HAND SANITIZERETHYL ALCOHOLAbsolutely Natural0c7d0d85-b919-4f47-9888-1ccc91054edf2024-12-11WarningsExact identifier
unii: 3K9958V90M
Zoey Naturals Lemon Squeeze Hand SanitizerETHYL ALCOHOLAbsolutely Natural, Inc.c119069c-092e-49ca-8f89-11fb75c768402024-12-11WarningsExact identifier
unii: 3K9958V90M
MELLOW HAND SANITIZER ALOEETHYL ALCOHOLL.e.d. Cosmetics, Inc.4377ba5e-21f6-407e-9b8c-25e3c6321a5b2024-12-10WarningsExact identifier
unii: 3K9958V90M
Tinted Sunscreen Cream SPF 30 4-Deep AmberTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisley5599922a-b020-477c-a44c-1db42ec5756a2024-12-10WarningsExact identifier
unii: 15FIX9V2JP
Tinted Sunscreen SPF 30 1-NaturalTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisleyb3d53a10-2647-492a-a05f-b97c3f716aa82024-12-10WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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