FDA.reportPublic FDA data

NDC 0378-1905-05 - Roflumilast

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
0378-1905
Requested NDC
0378-1905-05
Package NDCs from labels
0378-1905-93, 0378-1905-77, 0378-1905-05
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2021-01-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Roflumilast - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2021-01-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-1905ROFLUMILAST TABLET [MYLAN PHARMACEUTICALS INC.]3Legacy NDC20250104_0a917c07-edeb-44f0-a26c-8161166dc30b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1905-77EA - Each0378-1905c9bf27c8-61fb-42c3-a367-f16da4ffe44e12022-11-07
0378-1905-93EA - Each0378-19053b8d2047-1a3a-4f93-ad92-1a9846e1b21b12022-11-07

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 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZORYVEROFLUMILASTArcutis Biotherapeutics, Inc.f9e0b4a9-a227-4947-b00c-41fb18d165892026-09-02Warnings, Adverse reactionsExact identifier
unii: 0P6C6ZOP5U
ROFLUMILASTROFLUMILASTAmici Pharma Inc.cb3781ff-5350-4f9a-b247-0b04eb0f2b922026-09-01Warnings, Adverse reactionsExact identifier
unii: 0P6C6ZOP5U
ZORYVEROFLUMILASTArcutis Biotherapeutics, Inc.ec1bb0d1-f38a-4080-831a-68791d1d1fdb2026-07-20Adverse reactionsExact identifier
unii: 0P6C6ZOP5U
RoflumilastROFLUMILASTJubilant Cadista Pharmaceuticals Inc.aaa81c1b-f63d-4e61-8bfa-9d42d92043c72026-07-14Warnings, Adverse reactionsExact identifier
unii: 0P6C6ZOP5U
roflumilastROFLUMILASTAvKARE55009549-3f0c-1f58-e063-6294a90a6c032026-06-24Warnings, Adverse reactionsExact identifier
unii: 0P6C6ZOP5U
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
RoflumilastROFLUMILASTMajor Pharmaceuticalsca22f3e0-6f33-4f1c-97e5-0c962891067a2025-12-10Warnings, Adverse reactionsExact identifier
unii: 0P6C6ZOP5U
RoflumilastROFLUMILASTMAJOR PHARMACEUTICALSc51b80f3-a591-4db9-81b4-b91603e35d7c2025-12-04Warnings, Adverse reactionsExact identifier
unii: 0P6C6ZOP5U
ROFLUMILASTROFLUMILASTMicro Labs Limiteddc2a689f-cfa4-4863-9623-a9813dcf86a92025-07-24Warnings, Adverse reactionsExact identifier
unii: 0P6C6ZOP5U
ROFLUMILASTROFLUMILASTAurobindo Pharma Limited7cb11d48-6bb9-437b-bc7f-382050a2d3e62025-05-27Warnings, Adverse reactionsExact identifier
unii: 0P6C6ZOP5U
RoflumilastROFLUMILASTGolden State Medical Supply, Inc.30dd6eae-6435-cae1-e063-6294a90a003b2025-03-21Warnings, Adverse reactionsExact identifier
unii: 0P6C6ZOP5U
RoflumilastROFLUMILASTAscend Laboratories, LLC93d72a99-64dc-4fde-a5b8-78331fa607872025-03-13Warnings, Adverse reactionsExact identifier
unii: 0P6C6ZOP5U
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
RoflumilastROFLUMILASTAmerican Health Packaging913f1b95-9c46-40d5-a6e9-cff2e5e07eaa2024-11-21Warnings, Adverse reactionsExact identifier
unii: 0P6C6ZOP5U
RoflumilastROFLUMILASTNovadoz Pharmaceuticals LLC4d25f69c-58b7-4e2a-b835-4d0c76a83c7c2024-08-27Warnings, Adverse reactionsExact identifier
unii: 0P6C6ZOP5U
RoflumilastROFLUMILASTZydus Pharmaceuticals USA Inc.84145572-f320-4c3f-ab29-bd9f6c18746c2024-08-16Warnings, Adverse reactionsExact identifier
unii: 0P6C6ZOP5U
ROFLUMILASTROFLUMILASTBryant Ranch Prepackfa9c3bea-a04d-4ea9-ade9-ee8d9f6b1f722024-08-15Warnings, Adverse reactionsExact identifier
unii: 0P6C6ZOP5U

Reported adverse events (FAERS/openFDA)#

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