FDA.reportPublic FDA data

Epuris

Manufacturer
Galephar Pharmaceutical Research Inc. | Galephar Pharmaceutical Research Inc
Effective date
2024-12-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 21:19:01

Label at a glance#

ProductEpuris
Active ingredientISOTRETINOIN
Label structure4 sections

Label contents#

Full prescribing information#

Epuris 10 mg Box of 3 blister cards

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Epuris 10 mg Box of 3 blister cardsEpuris 10 mg Box of 3 blister cards

Epuris 20 mg Box of 3 blister cards

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Epuris 20 mg Box of 3 blister cardsEpuris 20 mg Box of 3 blister cards

Epuris 30 mg Box of 3 blister cards

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Epuris 30 mg Box of 3 blister cardsEpuris 30 mg Box of 3 blister cards

Epuris 40 mg Box of 3 blister cards

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Epuris 40 mg Box of 3 blister cardsEpuris 40 mg Box of 3 blister cards

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ISOTRETINOIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8300c0f6-79a4-735b-88ec-d781bfffdb10Product name520260305
644afe93-ba9b-4043-8e40-a9fe9af2d5d7Product name220250616
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
e5fedfa5-6b96-4769-872b-95d1e7f3a85aProduct name120200415
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66277-337-10Epuris10 in 1 BLISTER PACKCAPSULE102
66277-337-30Epuris3 in 1 BOXCAPSULE32
66277-338-10Epuris10 in 1 BLISTER PACKCAPSULE102
66277-338-30Epuris3 in 1 BOXCAPSULE32
66277-339-10Epuris10 in 1 BLISTER PACKCAPSULE102
66277-339-30Epuris3 in 1 BOXCAPSULE32
66277-340-10Epuris10 in 1 BLISTER PACKCAPSULE102
66277-340-30Epuris3 in 1 BOXCAPSULE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66277-337EPURIS (ISOTRETINOIN) CAPSULE [GALEPHAR PHARMACEUTICAL RESEARCH INC.]22 package rows20241208_d6ba7a44-ca13-e001-e053-2995a90afe0c.zip
66277-338EPURIS (ISOTRETINOIN) CAPSULE [GALEPHAR PHARMACEUTICAL RESEARCH INC.]22 package rows20241208_d6ba7a44-ca13-e001-e053-2995a90afe0c.zip
66277-339EPURIS (ISOTRETINOIN) CAPSULE [GALEPHAR PHARMACEUTICAL RESEARCH INC.]22 package rows20241208_d6ba7a44-ca13-e001-e053-2995a90afe0c.zip
66277-340EPURIS (ISOTRETINOIN) CAPSULE [GALEPHAR PHARMACEUTICAL RESEARCH INC.]22 package rows20241208_d6ba7a44-ca13-e001-e053-2995a90afe0c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66277-33766277-337-10, 66277-337-30
66277-33866277-338-10, 66277-338-30
66277-33966277-339-10, 66277-339-30
66277-34066277-340-10, 66277-340-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYL GALLATE8D4SNN7V92IACT
SOYBEAN OIL241ATL177AIACT
PEG-32 HYDROGENATED PALM GLYCERIDESG6EP177239IACT
ISOTRETINOINEH28UP18IFACTIB
SORBITAN MONOOLEATE06XEA2VD56IACT
PROPYL GALLATE8D4SNN7V92IACT
SOYBEAN OIL241ATL177AIACT
PEG-32 HYDROGENATED PALM GLYCERIDESG6EP177239IACT
ISOTRETINOINEH28UP18IFACTIB
SORBITAN MONOOLEATE06XEA2VD56IACT
PROPYL GALLATE8D4SNN7V92IACT
SOYBEAN OIL241ATL177AIACT
PEG-32 HYDROGENATED PALM GLYCERIDESG6EP177239IACT
ISOTRETINOINEH28UP18IFACTIB
SORBITAN MONOOLEATE06XEA2VD56IACT
PROPYL GALLATE8D4SNN7V92IACT
SOYBEAN OIL241ATL177AIACT
PEG-32 HYDROGENATED PALM GLYCERIDESG6EP177239IACT
ISOTRETINOINEH28UP18IFACTIB
SORBITAN MONOOLEATE06XEA2VD56IACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
289d5b9f-62bc-7112-e063-6394a90a3326d6ba7a44-ca13-e001-e053-2995a90afe0c2024-12-06Exact identifier
spl id: 289d5b9f-62bc-7112-e063-6394a90a3326
spl set id: d6ba7a44-ca13-e001-e053-2995a90afe0c

Reported adverse events (FAERS/openFDA)#

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