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 271 of 289 · 5,777 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SFT1 Sanitizing WipesALCOHOLORR Safetyb787fa1d-1e15-245b-e053-2a95a90a00a12023-10-26WarningsExact identifier
unii: 3K9958V90M
PEPPERMINT TWIST HAND SANITIZERALCOHOLTarget Corporation3203ebbd-413b-4579-bd1d-798008c588aa2023-10-26WarningsExact identifier
unii: 3K9958V90M
COCONUT MACAROON HAND SANITIZERALCOHOLTarget Corporation2eb42750-fa10-47c3-8398-e1d5929528d52023-10-26WarningsExact identifier
unii: 3K9958V90M
SUGARED LEMON HAND SANITIZERALCOHOLTarget Corporationd0ef9002-de9d-4d9b-91a6-cc2f0553c8632023-10-26WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLORR Safety Corporationb2e133f6-87f4-4a01-96af-8941190f558c2023-10-26WarningsExact identifier
unii: 3K9958V90M
SPARKLING CRANBERRY HAND SANITIZERALCOHOLTarget Corporation7ca828e8-ff43-4e4c-8e8c-d760a0f0c2222023-10-26WarningsExact identifier
unii: 3K9958V90M
Justice Glitter Berry Scented Anti-bacterial Hand Sanitizer LlamaALCOHOLTween Brands, Inc.6b6abc11-369d-4835-b420-8f3208ee4c422023-10-26WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLORR Safety Corporation59d944ce-b28b-491d-b158-334ed43ca4d42023-10-26WarningsExact identifier
unii: 3K9958V90M
VANILLA SUGAR COOKIE HAND SANITIZERALCOHOLTarget Corporationedca9c75-ba4e-4229-8fe7-a153932f7ca12023-10-26WarningsExact identifier
unii: 3K9958V90M
Justice Glitter Berry Scented Anti-bacterial Hand Sanitizer AALCOHOLTween Brands, Inc.fb1e3ba8-7b82-4bff-9261-e0a6f3dba3102023-10-26WarningsExact identifier
unii: 3K9958V90M
berries and cream hand sanitizerALCOHOLTarget Corporationc5731cb4-e79a-46af-b5bc-bcf01ea4c5de2023-10-26WarningsExact identifier
unii: 3K9958V90M
Instant HAND SANITIZERALCOHOLXact Xpressionsf166447d-95c1-4419-a7d1-e0dcb64d4f482023-10-26WarningsExact identifier
unii: 3K9958V90M
Justice Rainbow Raspberry Scented Anti-bacterial Hand SanitizerALCOHOLTween Brands, Inc.6b0ec518-52c9-4882-aa72-eb4e3064c77f2023-10-26WarningsExact identifier
unii: 3K9958V90M
Justice Vanilla Vibes Scented Anti-bacterial Hand SanitizerALCOHOLTween Brands, Inc.b85cec1d-d999-464b-8c7f-480e642b857c2023-10-26WarningsExact identifier
unii: 3K9958V90M
RASPBERRY SCENTED HAND SANITIZERALCOHOLTarget Brands,Inc.9bcc62bb-b691-d3ca-e053-2a95a90a284d2023-10-26WarningsExact identifier
unii: 3K9958V90M
Justice Moonstone Melon Scented Antibacterial Hand SanitizerALCOHOLTween Brands,Inc.9bcbcf14-b541-089a-e053-2995a90ac6a52023-10-26WarningsExact identifier
unii: 3K9958V90M
Justice Diamond Vanilla Scented Antibacterial Hand SanitizerALCOHOLTween Brands,Inc.9bcba4da-d3e8-d4c2-e053-2a95a90a432f2023-10-26WarningsExact identifier
unii: 3K9958V90M
Justice Cranberry Scented Anti-bacterial Hand SanitizerALCOHOLTween Brands, Inc.a912368d-58c5-4479-98d4-ca06496c4ea42023-10-26WarningsExact identifier
unii: 3K9958V90M
Justice Bubbling Blueberry Scented Anti-bacterial Hand SanitizerALCOHOLTween Brands, Inc.0cc54cfb-f426-4669-9f65-95e167ffa0d92023-10-26WarningsExact identifier
unii: 3K9958V90M
Watermelon Wonder Hand SanitizerALCOHOLTarget Corporation2872bd4b-854b-4041-ab04-ccb5b55f1be22023-10-26WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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