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 248 of 294 · 5,869 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COOLA Mineral Liplux Lip Balm SPF 30 Nude BeachTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCee2842c3-65e0-3904-e053-2a95a90aabff2024-05-22WarningsExact identifier
unii: 15FIX9V2JP
COOLA Mineral Liplux Lip Balm SPF 30 FirecrackerTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCee026a1c-885b-256f-e053-2a95a90af5642024-05-22WarningsExact identifier
unii: 15FIX9V2JP
Bare Republic SPF 50 Mineral Sunscreen Vanilla CocoTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCec96dee8-85e8-3147-e053-2995a90aaf532024-05-22WarningsExact identifier
unii: 15FIX9V2JP
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Bronze GoddessTITANIUM DIOXIDECOOLA, LLCeeb406c6-a543-379a-e053-2995a90a49982024-05-22WarningsExact identifier
unii: 15FIX9V2JP
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Fresh RoseTITANIUM DIOXIDECOOLA, LLCee01642f-478e-b307-e053-2a95a90a7d812024-05-22WarningsExact identifier
unii: 15FIX9V2JP
Bare Republic Mineral Matte Untinted Face SPF 30TITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCecabcc89-fb09-41a9-e053-2995a90a8b312024-05-22WarningsExact identifier
unii: 15FIX9V2JP
Bare Republic Mineral Matte Tinted Face SPF 30TITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCee018c21-dca7-28aa-e053-2a95a90a3bdb2024-05-22WarningsExact identifier
unii: 15FIX9V2JP
Bare Republic Mineral Shimmer SPF 30 Golden DazeTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCeeb70034-0f8d-a46d-e053-2a95a90a81302024-05-22WarningsExact identifier
unii: 15FIX9V2JP
Bare Republic Mineral Shimmer SPF 30 Diamond DustTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCeec83ecb-d0ab-7857-e053-2995a90a40ed2024-05-22WarningsExact identifier
unii: 15FIX9V2JP
Anti Bacterial Hand Gel A Thousand WishesALCOHOLBath & Body Works, Inc.190f2d33-3bed-27fa-e063-6294a90a15af2024-05-22WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Afternoon Apple PickingALCOHOLBath & Body Works, Inc.190ff051-85b4-cdfb-e063-6394a90aee332024-05-22WarningsExact identifier
unii: 3K9958V90M
Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEJune Jacobs Labs LLC18e1edd9-e39b-c91f-e063-6394a90a32a02024-05-20WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEJune Jacobs Labs, LLC18e4c50d-eb91-c269-e063-6394a90a79992024-05-20WarningsExact identifier
unii: 15FIX9V2JP
Protectif UntintedZINC OXIDE AND TITANIUM DIOXIDEAllure Labs18aa2604-c8f0-ca04-e063-6294a90a1c252024-05-17WarningsExact identifier
unii: 15FIX9V2JP
Nourishing Hand Sanitizer LimonALCOHOLNoshinkud70fba7a-513f-0341-e053-2a95a90add862024-05-15WarningsExact identifier
unii: 3K9958V90M
Nourishing Hand Sanitizer VetiverALCOHOLNoshinkud70fb84c-fdbc-6ba8-e053-2995a90ab5292024-05-15WarningsExact identifier
unii: 3K9958V90M
Noshinku Bergamot Hand SanitizerALCOHOLNoshinku53fea81e-4482-6fae-e054-00144ff8d46c2024-05-14WarningsExact identifier
unii: 3K9958V90M
Noshinku Eucalyptus Hand SanitizerALCOHOLNoshinku9dcb8b51-d1bb-4305-a5ff-8cc8bdcdc4c02024-05-14WarningsExact identifier
unii: 3K9958V90M
Noshinku Lavender Hand SanitizerALCOHOLNoshinkua57e44b2-f5fa-4c3c-a59c-aa73bfbb66cf2024-05-14WarningsExact identifier
unii: 3K9958V90M
Leader Decolorized IodineALCOHOL LIQUIDCardinal Health, 110 dba Leader822f6f28-956f-dd82-e053-2991aa0ae7522024-05-13WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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