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 253 of 294 · 5,869 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Isopropyl Alcohol ISOPROPYL ALCOHOL SPRAY Dynarex Corporation 116e0c9c-cbe0-bf67-e063-6394a90ae530 2024-02-15 Warnings Exact identifier unii: ND2M416302 Sheet SPF 30 Mineral TITANIUM DIOXIDE, ZINC OXIDE Vivier Pharma Inc. bbb5b87c-d641-3ba2-e053-2a95a90a0f70 2024-02-14 Warnings Exact identifier unii: 15FIX9V2JP sheer tint SPF 45 BROAD SPECTRUM CP Skin Health Group, Inc. b7c5cedd-ff68-74de-e053-2a95a90a3796 2024-02-14 Warnings Exact identifier unii: 15FIX9V2JP Instant Hand Sanitizer ALCOHOL Safetec of America, Inc. 016f9770-3dd5-4480-a687-f9bb2ea73e86 2024-02-12 Warnings Exact identifier unii: 3K9958V90M REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/O OCTINOXATE, TITANIUM DIOXIDE CLINIQUE LABORATORIES LLC 10f7ec01-541b-a15a-e063-6294a90aa9df 2024-02-09 Warnings Exact identifier unii: 15FIX9V2JP Instant Hand Sanitizer ALCOHOL Safetec of America, Inc. 89251271-2cb4-4445-894c-153211b75202 2024-02-08 Warnings Exact identifier unii: 3K9958V90M Antiseptic ALCOHOL, LIDOCAINE HYDROCHLORIDE Safetec of America, Inc. 71aeaf86-2b4d-4945-9606-a9db0ab6b726 2024-02-07 Warnings Exact identifier unii: 3K9958V90M ArmiCare Hand Sanitizer ALCOHOL Armis Biopharma, Inc acd02e65-7dfb-4d72-af5d-8063cce982f6 2024-02-06 Warnings Exact identifier unii: 3K9958V90M Antiseptic ALCOHOL Safetec of America, Inc. aeecceb7-0753-4908-b1a2-d7e18ba350ec 2024-02-05 Warnings Exact identifier unii: 3K9958V90M Antimicrobial ALCOHOL Safetec of America, Inc. 4a070d45-f7fd-4eab-a2ba-48445d54fe5d 2024-02-05 Warnings Exact identifier unii: 3K9958V90M Antibacterial Hand Sanitizer ALCOHOL TEKWELD SOLUTIONS, INC. 45af86a4-a413-0309-e054-00144ff88e88 2024-02-05 Warnings Exact identifier unii: 3K9958V90M Instant Hand Sanitizer ALCOHOL Safetec of America, Inc. 6d8677fa-8d7e-4eb5-9f20-ec5a84e1c23f 2024-02-04 Warnings Exact identifier unii: 3K9958V90M COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Golden Hour TITANIUM DIOXIDE COOLA, LLC edfda0f5-0f72-5cc7-e053-2a95a90ae38d 2024-02-02 Warnings Exact identifier unii: 15FIX9V2JP COOLA Mineral Liplux Lip Balm SPF 30 Summer Crush ZINC OXIDE COOLA, LLC edc6754e-dabb-5bff-e053-2a95a90a7390 2024-02-02 Warnings Exact identifier unii: 15FIX9V2JP COOLA Mineral Liplux Lip Balm SPF 30 Skinny Dip ZINC OXIDE COOLA, LLC ee01f936-81a9-a54d-e053-2a95a90a5227 2024-02-02 Warnings Exact identifier unii: 15FIX9V2JP toty Solaria Mineral TITANIUM DIOXIDE, ZINC OXIDE Chipican LLC e9d590d8-e71a-0715-e053-2a95a90a5acf 2024-02-01 Warnings Exact identifier unii: 15FIX9V2JP ATOMY DERMA CALMING SUN TITANIUM DIOXIDE ATOMY CO., LTD. fd5fc3ba-6e7c-4e48-8e65-47c03141df45 2024-01-30 Warnings Exact identifier unii: 15FIX9V2JP Topcare Swimmers Ear Drops ISOPROPYL ALCOHOL Topco Associates LLC 0fddeb43-fee0-d43c-e063-6394a90a738a 2024-01-26 Warnings Exact identifier unii: ND2M416302 No More Products GLYCERIN, KAOLIN, CALAMINE, MENTHOL Sarati International, Inc 102e7dbb-06dc-f4d1-e063-6394a90aa3eb 2024-01-26 Warnings Exact identifier unii: PDC6A3C0OX Pranicura 5 GLYCERIN, KAOLIN, CALAMINE, MENTHOL Sarati International, Inc. 0fe10710-ac59-4fc5-e063-6294a90a48fc 2024-01-26 Warnings Exact identifier unii: PDC6A3C0OX
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.