FDA.reportPublic FDA data

NDC 72205-201-13 - 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
72205-201
Requested NDC
72205-201-13
Package NDCs from labels
72205-201-11, 72205-201-24, 72205-201-13, 72205-201-32, 72205-201-30
Manufacturer
Novadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED | MSN Pharmaceuticals Inc.
Effective date
2024-08-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
RoflumilastNovadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED | MSN Pharmaceuticals Inc.2024-08-27Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-201-11Roflumilast10 in 1 BLISTER PACKTABLET103
72205-201-13Roflumilast14 in 1 BLISTER PACKTABLET143
72205-201-24Roflumilast2 in 1 CARTONTABLET23
72205-201-30Roflumilast30 in 1 BOTTLETABLET303
72205-201-32Roflumilast2 in 1 CARTONTABLET23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-201ROFLUMILAST TABLET [NOVADOZ PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 5 package rows20240829_4d25f69c-58b7-4e2a-b835-4d0c76a83c7c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-201-11EA - Each72205-201df07c6ad-3ce9-4fc7-8176-63c62d2a490512023-02-06
72205-201-13EA - Each72205-2019fe84c60-5b09-49c1-bcde-e8fc62a685c612023-05-05
72205-201-24EA - Each72205-20173274145-133e-458c-880d-3ae6d788ba9712022-11-07
72205-201-32EA - Each72205-20110734d78-22f1-4c1e-8e5d-e10e2b3ffd1012022-11-07

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 · 33 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
rxcui: 2001319
rxcui: 1091839
unii: 0P6C6ZOP5U
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
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
rxcui: 2001319
rxcui: 1091839
unii: 0P6C6ZOP5U
roflumilastROFLUMILASTAvKARE55009549-3f0c-1f58-e063-6294a90a6c032026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 2001319
rxcui: 1091839
unii: 0P6C6ZOP5U
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
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
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: 6OZP39ZG8H
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
application number: ANDA208256
rxcui: 1091839
unii: 0P6C6ZOP5U
RoflumilastROFLUMILASTMAJOR PHARMACEUTICALSc51b80f3-a591-4db9-81b4-b91603e35d7c2025-12-04Warnings, Adverse reactionsExact identifier
application number: ANDA208256
rxcui: 2001319
rxcui: 1091839
unii: 0P6C6ZOP5U
ROFLUMILASTROFLUMILASTMicro Labs Limiteddc2a689f-cfa4-4863-9623-a9813dcf86a92025-07-24Warnings, Adverse reactionsExact identifier
rxcui: 2001319
rxcui: 1091839
unii: 0P6C6ZOP5U
ROFLUMILASTROFLUMILASTAurobindo Pharma Limited7cb11d48-6bb9-437b-bc7f-382050a2d3e62025-05-27Warnings, Adverse reactionsExact identifier
rxcui: 2001319
rxcui: 1091839
unii: 0P6C6ZOP5U
RoflumilastROFLUMILASTGolden State Medical Supply, Inc.30dd6eae-6435-cae1-e063-6294a90a003b2025-03-21Warnings, Adverse reactionsExact identifier
rxcui: 1091839
unii: 0P6C6ZOP5U
RoflumilastROFLUMILASTAscend Laboratories, LLC93d72a99-64dc-4fde-a5b8-78331fa607872025-03-13Warnings, Adverse reactionsExact identifier
rxcui: 2001319
rxcui: 1091839
unii: 0P6C6ZOP5U
RoflumilastROFLUMILASTAmerican Health Packaging913f1b95-9c46-40d5-a6e9-cff2e5e07eaa2024-11-21Warnings, Adverse reactionsExact identifier
rxcui: 1091839
unii: 0P6C6ZOP5U

Reported adverse events (FAERS/openFDA)#

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