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 194 of 295 · 5,888 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sei Bella Tinted BB Moisturizing Cream230 NMelaleuca Inc.2f133abb-cad2-2ac8-e063-6294a90aa4802025-02-26WarningsExact identifier
unii: 15FIX9V2JP
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 4612200737139-bab8-40be-ad85-32526b5eab102025-02-26WarningsExact identifier
unii: ND2M416302
AUM Alcohol PadALCOHOL PADSLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS632da1b7-70bb-467d-81b2-39536f9fff3c2025-02-26WarningsExact identifier
unii: ND2M416302
COCONUT SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.fe347d07-496a-468a-bc38-d47b0f22c4332025-02-25WarningsExact identifier
unii: 3K9958V90M
CITRUS SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.64b2fef3-8d06-471d-b950-d4c355119dfa2025-02-25WarningsExact identifier
unii: 3K9958V90M
LAVENDER SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.0e5e21c3-9ee5-44be-988a-f82ac95230592025-02-25WarningsExact identifier
unii: 3K9958V90M
ALOE SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.aacde143-ecf1-47ce-ada3-8e74551d06592025-02-25WarningsExact identifier
unii: 3K9958V90M
EUCALYPTUS SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.068ed8c0-1fff-42dd-a217-684201c160232025-02-25WarningsExact identifier
unii: 3K9958V90M
SHEA BUTTER SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.669451fa-7557-4ef5-a668-fe4fea1f0c9b2025-02-25WarningsExact identifier
unii: 3K9958V90M
Blink Nourish Dry EyeGLYCERINBausch & Lomb Incorporatedcf2b4e19-af0a-472e-9a2d-9b4fa3e9c9a42025-02-25WarningsExact identifier
unii: PDC6A3C0OX
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2efb73a6-601d-61a4-e063-6294a90af8252025-02-25WarningsExact identifier
unii: 15FIX9V2JP
Smart Care Crayola HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.def18e33-0a6b-40f8-a771-fcae1e6a1c822025-02-25WarningsExact identifier
unii: 3K9958V90M
Smart Care SPIDER-MAN HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.db147cc8-6323-428b-b506-8ab7211cb3e62025-02-25WarningsExact identifier
unii: 3K9958V90M
Smart Care Hot Wheels HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.046d534c-1bde-439c-9a90-8713aaada1a12025-02-25WarningsExact identifier
unii: 3K9958V90M
Smart Care Barbie HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.e9acb658-946d-405c-ad41-8b52542998bd2025-02-25WarningsExact identifier
unii: 3K9958V90M
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2ee82379-6609-fd8e-e063-6294a90acf6c2025-02-24WarningsExact identifier
unii: 15FIX9V2JP
Hand SanitizerALCOHOLUniversal Synergetics, Inc0dd6884c-935f-4523-b19a-201b7a8666fc2025-02-24WarningsExact identifier
unii: 3K9958V90M
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLWalgreens78ed5594-433a-4f90-ad39-51e2a7dd2e212025-02-21WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLWalgreens9effa6c9-020d-4a2d-ad26-449d4119b6a02025-02-21WarningsExact identifier
unii: ND2M416302
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION oilyOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC10edc0c1-9359-4c7a-a56e-bad06fea00562025-02-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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