Home NDC 68308-784-01 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 Label Manufacturer Effective date Type Isotretinoin - Mayne Pharma Mayne Pharma 2024-06-26 HUMAN PRESCRIPTION DRUG LABEL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68308-784-01 Isotretinoin 10 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 10 4 68308-784-30 Isotretinoin 3 in 1 BOX CAPSULE, LIQUID FILLED 3 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68308-784 ISOTRETINOIN CAPSULE, LIQUID FILLED [MAYNE PHARMA] 4 Current NDC, 2 package rows 20240628_0114567b-3bac-490d-b9eb-03a6c5d90935.zip
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 240 of 294 · 5,869 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Essential Sheer SPF 50 ZINC OXIDE TITANIUM DIOXIDE Topiderm, Inc. 2132dc18-85ee-4449-86d2-d9f698f286c6 2024-07-31 Warnings Exact identifier unii: 15FIX9V2JP Proceuticals Private Label by TiZO tinted foaming mineral sunscreen TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, Ltd 1e78109f-4d2e-2705-e063-6294a90a5ad3 2024-07-30 Warnings Exact identifier unii: 15FIX9V2JP Replenix Sheer SPF 50 ZINC OXIDE TITANIUM DIOXIDE Topiderm, Inc. 37d1f454-3bc9-4ce5-863c-0d4f6fa18fb4 2024-07-29 Warnings Exact identifier unii: 15FIX9V2JP WhiskCare 375 Fragrance Free ALCOHOL Whisk Products, Inc. c6787b12-ab90-4305-a6cc-55fd2c57cd2d 2024-07-26 Warnings Exact identifier unii: 3K9958V90M Shimmy Original Hand Sanitizer ALCOHOL Shimmy Products LLC c4c135ed-3b6a-69c8-e053-2a95a90aad1c 2024-07-25 Warnings Exact identifier unii: 3K9958V90M Shimmy Rose Hibiscus Hand Sanitizer ALCOHOL Shimmy Products LLC c50b5044-31fd-672a-e053-2995a90a49fc 2024-07-25 Warnings Exact identifier unii: 3K9958V90M Shimmy Meyer Lemon Hand Sanitizer ALCOHOL Shimmy Products LLC c50b9543-e276-9052-e053-2a95a90a8325 2024-07-25 Warnings Exact identifier unii: 3K9958V90M Shimmy Neutral Hand Sanitizer ALCOHOL Shimmy Products LLC df2761b9-0fca-5e2a-e053-2a95a90a9b8d 2024-07-25 Warnings Exact identifier unii: 3K9958V90M Symmetry Foaming Hand Sanitizer ALCOHOL Buckeye International, Inc. bcab4842-50ff-4c7f-8b85-0126f4b585b0 2024-07-23 Warnings, Adverse reactions Exact identifier unii: 3K9958V90M Altra Hand Sanitizer with Aloe and Vitamin E ALCOHOL Buckeye International, Inc. a2974445-eaa3-d9f0-e053-2995a90a78fc 2024-07-23 Warnings Exact identifier unii: 3K9958V90M LAVENDER SCENTED HAND SANITIZER PEN ALCOHOL Fourstar Group USA, Inc. 5c27f212-4010-44de-9e9d-758ffdfcc5c1 2024-07-18 Warnings Exact identifier unii: 3K9958V90M CITRUS SCENTED HAND SANITIZER PEN ALCOHOL Fourstar Group USA, Inc b3c59433-a4cd-42cb-9492-fcdc19ca765c 2024-07-18 Warnings Exact identifier unii: 3K9958V90M COCONUT SCENTED HAND SANITIZER PEN ALCOHOL Fourstar Group USA, Inc. 2fa53710-c084-48e0-8300-511d0d93a88d 2024-07-18 Warnings Exact identifier unii: 3K9958V90M Derma E Sun Defense Face SPF 30 ZINC OXIDE TITANIUM DIOXIDE derma e d90b8f81-de7a-4022-800a-90f063e94180 2024-07-17 Warnings Exact identifier unii: 15FIX9V2JP PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreen TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD 1d611494-648b-6e5f-e063-6294a90a4500 2024-07-16 Warnings Exact identifier unii: 15FIX9V2JP Ultra Prep Alcohol Prep Pads ISOPROPYL ALCOHOL Quality Medical Products USA, Inc. f81a63dd-a699-459f-ab52-f63a6550b680 2024-07-16 Warnings Exact identifier unii: ND2M416302 SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE L'Oreal USA Products Inc 8df98d97-a5d2-4d52-8bd2-130a13501d60 2024-07-16 Warnings Exact identifier unii: 15FIX9V2JP b.pure Hand Sanitizer Lemon Scented ALCOHOL FOURSTAR GROUP USA, INC. bc35f9ec-e453-4994-91ae-2294d058e45d 2024-07-12 Warnings Exact identifier unii: 3K9958V90M b.pure Hand Sanitizer Watermelon Scented ALCOHOL FOURSTAR GROUP USA, INC. e0ed1b57-2d7e-4e63-96f5-dbbb2aef26df 2024-07-12 Warnings Exact identifier unii: 3K9958V90M b.pure Hand Sanitizer Green Apple Scented ALCOHOL FOURSTAR GROUP USA, INC. 7c870d8f-c298-4469-b6d1-f318f6adfd26 2024-07-12 Warnings Exact identifier unii: 3K9958V90M
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.