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 222 of 294 · 5,869 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MISSHA M Perfect Cover BB Cream SPF42 (No. 25)ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.604e7a49-7986-11ee-e053-2a91aa0a1bee2024-12-05WarningsExact identifier
unii: 15FIX9V2JP
MISSHA M Perfect Cover BB No 27ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.c4e16cec-c7db-4e5e-9d05-5d7afdb790912024-12-05WarningsExact identifier
unii: 15FIX9V2JP
MISSHA M Perfect Cover BB SPF42 No29OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDEAble C&C Co., Ltd.3fc90114-4cdf-273e-e054-00144ff8d46c2024-12-05WarningsExact identifier
unii: 15FIX9V2JP
MISSHA M Perfect Cover BB No 31ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.95862d15-d977-7276-e053-2995a90ab6902024-12-05WarningsExact identifier
unii: 15FIX9V2JP
MISSHA M Perfect Cover BB Cream SPF42 No. 25ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.9c6f48b1-007b-434f-b756-242e3390e9b72024-12-05WarningsExact identifier
unii: 15FIX9V2JP
MISSHA ALL AROUND VITA C SUNSCREENZINC OXIDE, HOMOSALATE, ETHYLHEXYL SALICYLATE, TITANIUM DIOXIDEAble C&C Co., Ltd.1a7ec673-328a-8924-e063-6294a90a2f3d2024-12-05WarningsExact identifier
unii: 15FIX9V2JP
PURELL Advanced Hand Sanitizer Energizing MintALCOHOLGOJO Industries, Inc.a77f2ac3-2a8c-45e7-a65e-bd58e834249b2024-12-05WarningsExact identifier
unii: 3K9958V90M
InstantINSTANTUnlimited Salesbd310bb2-37e5-1ed7-e053-2995a90a36b42024-12-05WarningsExact identifier
unii: 3K9958V90M
ALPET E3 PLUS HAND SANITIZERALCOHOLBest Sanitizers, Inc.d6d64945-4cd4-4926-9ef9-898cea89e8112024-12-05WarningsExact identifier
unii: 3K9958V90M
ALPET E3 HAND SANITIZERISOPROPYL ALCOHOLBest Sanitizers, Inc.08055e08-039d-43da-adad-adaf6639fa842024-12-05WarningsExact identifier
unii: ND2M416302
SMART SAN HAND SANITIZERALCOHOLBest Sanitizers, Inc.1c018851-82e0-4f2c-8f40-31674cd6fe2b2024-12-05WarningsExact identifier
unii: 3K9958V90M
ALPET E3 HAND SANITIZER FOAMALCOHOLBest Sanitizers, Inc.53573e1a-a3f8-4598-8248-ec4a62392d002024-12-05WarningsExact identifier
unii: 3K9958V90M
SMART SAN HAND SANITIZER FRAGRANCE-FREEALCOHOLBest Sanitizers, Inc.bce412dc-21db-4c63-b4fc-33538cda74242024-12-05WarningsExact identifier
unii: 3K9958V90M
SMART SAN HAND SANITIZERALCOHOLBest Sanitizers, Inc.8a2cc051-604c-43a7-9f65-2f929b759daa2024-12-05WarningsExact identifier
unii: 3K9958V90M
OPS 70 PERCENT ALCOHOL FOAMING SKIN SANITIZERETHYL ALCOHOLArcher Manufacturing, Inc.d05fbe85-26de-0d24-e053-2a95a90ab5cb2024-12-05WarningsExact identifier
unii: 3K9958V90M
BLACK OPS 70 PERCENT ALCOHOL FOAMING SKIN SANITIZERETHYL ALCOHOLArcher Manufacturing, Inc.d334b7f0-01dc-7f59-e053-2a95a90a06b52024-12-05WarningsExact identifier
unii: 3K9958V90M
EGF FGF DNA UV SHIELDETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATEDermaesthetics Inc.13e2630d-9915-4287-91fd-deb6721501312024-12-04WarningsExact identifier
unii: 15FIX9V2JP
alcohol pad 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.03a6e8d4-535d-b316-e063-6294a90aebf52024-12-04WarningsExact identifier
unii: 3K9958V90M
MISSHA M Perfect Cover BB No 13ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.95846b5e-5b72-26bc-e053-2a95a90ae0f72024-12-04WarningsExact identifier
unii: 15FIX9V2JP
MISSHA M Perfect Cover BB No 21ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.9585d3d2-806c-36e3-e053-2a95a90a28fa2024-12-04WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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