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 189 of 295 · 5,897 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl alcohol 70 percent WintergreenISOPROPYL ALCOHOLTARGET Corporationf4ea4aa4-42c6-456b-9908-24f256d4a7692025-04-14WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol WintergreenISOPROPYL ALCOHOLStrategic Sourcing Services LLC8dac7168-0140-470f-bf66-fd0aed519b382025-04-14WarningsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC227b9292-0be7-47ef-ac8e-a9a8cc2fb4162025-04-14WarningsExact identifier
unii: ND2M416302
Hand Sanitizer MistETHYL ALCOHOLZHEJIANG GAORONG COSMETIC CO.,LTD.3293c5a7-d39b-4f4e-e063-6394a90abf9a2025-04-12WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer MistETHYL ALCOHOLZHEJIANG GAORONG COSMETIC CO.,LTD.327eb76b-0822-a6a6-e063-6394a90ab7392025-04-11WarningsExact identifier
unii: 3K9958V90M
Smart Care Luxury Hand Sanitizer 1.35oz - Whispering WoodsALCOHOLShenzhen Lantern Scicence Co.,Ltd.32676185-14e8-a56d-e063-6294a90adc7b2025-04-10WarningsExact identifier
unii: 3K9958V90M
Smart Care Luxury Hand Sanitizer 1.35oz - Midnight MuskALCOHOLShenzhen Lantern Scicence Co.,Ltd.3267a5ff-03cb-86c9-e063-6394a90a678d2025-04-10WarningsExact identifier
unii: 3K9958V90M
Smart Care Luxury Hand Sanitizer 1.35oz - Meadow MirageALCOHOLShenzhen Lantern Scicence Co.,Ltd.32681df8-0af0-d9c5-e063-6394a90a00f02025-04-10WarningsExact identifier
unii: 3K9958V90M
Smart Care Luxury Hand Sanitizer 1.35oz - Botanic BlushALCOHOLShenzhen Lantern Scicence Co.,Ltd.32687109-0843-09e9-e063-6394a90a60272025-04-10WarningsExact identifier
unii: 3K9958V90M
Smart Care Luxury Hand Sanitizer 1.35oz - Golden GroveALCOHOLShenzhen Lantern Scicence Co.,Ltd.3268b7e9-3de4-335b-e063-6394a90adfa02025-04-10WarningsExact identifier
unii: 3K9958V90M
Smart Care Luxury Hand Sanitizer 1.35oz - Citrus SuedeALCOHOLShenzhen Lantern Scicence Co.,Ltd.3268f248-64da-7a22-e063-6294a90a6dd32025-04-10WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.32692c9c-11bb-d772-e063-6294a90a50d42025-04-10WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Candy CaneALCOHOLShenzhen Lantern Scicence Co.,Ltd.32695a30-f9dd-11aa-e063-6294a90a78392025-04-10WarningsExact identifier
unii: 3K9958V90M
Walgreens 91% Isopropyl AlcoholISOPROPYL ALCOHOLWalgreens Co.21f204f9-a271-0062-e063-6294a90addcc2025-04-10WarningsExact identifier
unii: ND2M416302
Smoothing Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDANIEL BEHROOZAN MD A MEDICAL CORPORATION327246c2-9d7a-2d34-e063-6294a90a5fb72025-04-10Exact identifier
unii: 15FIX9V2JP
Clarity Rx Physical Skin Defense SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.b5111012-97b9-4908-95a0-d09595f9c4d92025-04-10WarningsExact identifier
unii: 15FIX9V2JP
Smart Care STRAWBERRY HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.a07bf6a1-3ea3-43ac-b032-90d5a25864602025-04-10WarningsExact identifier
unii: 3K9958V90M
Tinted Mineral Sunscreen SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.13e5085f-df2b-46b2-b063-e58ce43799052025-04-09WarningsExact identifier
unii: 15FIX9V2JP
B-Pure Moisturizing Hand Sanitizer Pumpkin Vanilla ScentedALCOHOLFOURSTAR GROUP USA, INC.68d0dddc-9d48-4c8c-9b0c-d084d317cb5c2025-04-09WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Honey Crisp Apple ScentedALCOHOLFOURSTAR GROUP USA, INC.04372892-49a9-491f-9d78-bf74aaadb6f12025-04-09WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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