FDA.reportPublic FDA data

NDC 66277-338 - Epuris

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
66277-338
Package NDCs from labels
66277-338-10, 66277-338-30
Manufacturer
Galephar Pharmaceutical Research Inc. | Galephar Pharmaceutical Research Inc
Effective date
2024-12-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Epuris - Galephar Pharmaceutical Research Inc. | Galephar Pharmaceutical Research IncGalephar Pharmaceutical Research Inc. | Galephar Pharmaceutical Research Inc2024-12-06HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66277-338EPURIS (ISOTRETINOIN) CAPSULE [GALEPHAR PHARMACEUTICAL RESEARCH INC.]22 package rows20241208_d6ba7a44-ca13-e001-e053-2995a90afe0c.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 1 of 2 · 37 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ISOTRETINOINISOTRETINOINAurobindo Pharma Limited4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e62026-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
IsotretinoinISOTRETINOINAmneal Pharmaceuticals LLCc2917c3d-3499-48a0-ba53-120cb979195d2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
IsotretinoinISOTRETINOINZydus Pharmaceuticals USA Inc.31f62a49-4c6d-4ce3-a0ca-d159562370b12026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
IsotretinoinISOTRETINOINActavis Pharma, Inc.1cf11710-f966-4529-8e08-02175f588bca2026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
Absorica LDISOTRETINOINSun Pharmaceutical Industries, Inc.3ef0cff8-19c1-4441-b780-fca6c7ee16152026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
AmnesteemISOTRETINOINMylan Pharmaceuticals Inc.b2cb63c9-f825-4991-9a2c-6260f1bbcc2c2026-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
ClaravisISOTRETINOINTeva Pharmaceuticals USA, Inc.a31fd109-d0fd-4ab9-ba98-a3d64333c18d2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
NutriLipid I.V. Fat EmulsionSOYBEAN OILB. Braun Medical Inc.193290b1-a0a1-4054-a22a-de5c9e7a8b732026-07-10Warnings, Adverse reactionsExact identifier
unii: 241ATL177A
IsotretinoinISOTRETINOINZydus Pharmaceuticals USA Inc.28948c32-a598-4bb5-bdb5-efbd87214d982026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
ZENATANEISOTRETINOINBluePoint Laboratories486d4a4b-0de5-431a-bef7-dae6b0e4fa202026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
IsotretinoinISOTRETINOINUpsher-Smith Laboratories, LLC08529687-26b2-41e5-b6fb-35b4c0d891fe2026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
IsotretinoinISOTRETINOINUpsher-Smith Laboratories, LLCc369e1c3-90c5-4768-9741-56c62253a2c42026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
ACCUTANEISOTRETINOINJG Pharma Inc.5b524a51-a16b-496e-b764-11c98c479c362026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH28UP18IF
IntralipidI.V. FAT EMULSIONProPharma Distribution48c12fbe-c5e8-a1fc-e063-6294a90a15ae2026-01-19Warnings, Adverse reactionsExact identifier
unii: 241ATL177A
IntralipidI.V. FAT EMULSIONFresenius Kabi USA, LLC61e025f1-a38e-4af2-9e18-13ea12977cf52025-11-19Warnings, Adverse reactionsExact identifier
unii: 241ATL177A
IntralipidI.V. FAT EMULSIONProPharma Distribution42dffe5a-892b-03ec-e063-6394a90ae50c2025-11-05Warnings, Adverse reactionsExact identifier
unii: 241ATL177A
IntralipidI.V. FAT EMULSIONFresenius Kabi USA, LLC98460eae-5195-48d2-ab73-00d276879ef62025-10-09Warnings, Adverse reactionsExact identifier
unii: 241ATL177A
IntralipidI.V. FAT EMULSIONFresenius Kabi USA, LLCbdcc364b-77b2-4939-8add-03e5396d46c22025-10-08Warnings, Adverse reactionsExact identifier
unii: 241ATL177A
PerikabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCc2eb5522-8572-45f4-869d-42f9fd251bb62025-09-15Warnings, Adverse reactionsExact identifier
unii: 241ATL177A
KabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCafeb4837-a759-4484-a76e-e04611c459e72025-09-11Warnings, Adverse reactionsExact identifier
unii: 241ATL177A

Reported adverse events (FAERS/openFDA)#

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