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 179 of 295 · 5,897 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY RIKI LLC37f2c5ed-c2f5-e569-e063-6294a90a15b12025-06-19Exact identifier
unii: 15FIX9V2JP
Aloe UP SPF 30 MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35967b33-bdfb-ee3c-e063-6294a90a75f62025-06-18WarningsExact identifier
unii: 15FIX9V2JP
Aloe Up SPF 50 MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35b9dcfa-05f3-3d7b-e063-6394a90a18f12025-06-18WarningsExact identifier
unii: 15FIX9V2JP
Aloe Up SPF 50 Kids MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35cd16b0-bd81-8f68-e063-6294a90a3d8c2025-06-18WarningsExact identifier
unii: 15FIX9V2JP
WISH RUBBING ALCOHOL 99%ISOPROPYL ALCOHOLLJ Pharmaa06953d7-d685-45ac-b1c6-e66dc7a05bca2025-06-18WarningsExact identifier
unii: ND2M416302
Sweet Orange Bergamot and AloeETHYL ALCOHOLALO New York LLC31cecf1e-1d6b-0033-e063-6294a90a7b8e2025-06-18WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Brazilian Caramel ScentedALCOHOLFourstar Group USA, Inc.30aaedbb-ffb9-4d00-a763-d5444074deb22025-06-17WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Champagne ScentedALCOHOLFourstar Group USA, Inc.52c0f174-3c4d-4e81-91c5-f2c76bffc5302025-06-17WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Cherry Pie ScentedALCOHOLFourstar Group USA, Inc.89d8771b-e6eb-4a09-9d06-8c7a692243bd2025-06-17WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Confetti Cake ScentedALCOHOLFourstar Group USA, Inc.4e87ec93-7e9b-4a6e-8286-93dc1e75c2f52025-06-17WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Jasmine Dragon Fruit ScentedALCOHOLFourstar Group USA, Inc.144da5c7-45e9-4980-a61c-81c3b9d8e7872025-06-17WarningsExact identifier
unii: 3K9958V90M
Alco Hand SanitizerALCOHOLWoodbine Products Company3bd696e2-9125-4604-ace9-d931d9fb5ea32025-06-17WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Peach ScentedALCOHOLFourstar Group USA, Inc.340879c5-4a51-44ca-9b28-9f24a1111efd2025-06-17WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Strawberry Cake ScentedALCOHOLFourstar Group USA, Inc.d4db52eb-d207-410e-bcc0-08a97eb141cc2025-06-17WarningsExact identifier
unii: 3K9958V90M
Universal 70% Rubbing Alcohol with Wintergreen and GlycerinISOPROPYL ALCOHOLUniversal Distribution Center LLC1fdff866-f534-4c16-b755-b2efd1e6e8372025-06-17WarningsExact identifier
unii: ND2M416302
Smart Care CARAMEL HONEY HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.ffd8dfae-3205-455d-8bbe-9e9f8ee859e12025-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care SWEET CITRUS HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.5bcc5f69-713c-45c5-aa19-6a1086c71c352025-06-17WarningsExact identifier
unii: 3K9958V90M
Skin by Scottie Beach Mode Mineral Sunscreen Roll-On SPF 30TITANIUM DIOXIDE, ZINC OXIDESKIN CARE BY SCOTTIE LLCa9afa58c-f438-48c6-bd30-eda41334df742025-06-16WarningsExact identifier
unii: 15FIX9V2JP
Summit Smelling SaltsSUMMIT SMELLING SALTSWashburn Ventures LLC36b6ed08-4a98-6b31-e063-6394a90a6fb72025-06-16WarningsExact identifier
unii: 5138Q19F1X
Dermaka Sunscreen SPF 42, TintedTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS9a967cd1-9eec-4255-b14b-ac2e33e4dbf02025-06-16WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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