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 2 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RoflumilastROFLUMILASTZydus Pharmaceuticals USA Inc.84145572-f320-4c3f-ab29-bd9f6c18746c2024-08-16Warnings, Adverse reactionsExact identifier
rxcui: 2001319
rxcui: 1091839
unii: 0P6C6ZOP5U
ROFLUMILASTROFLUMILASTBryant Ranch Prepackfa9c3bea-a04d-4ea9-ade9-ee8d9f6b1f722024-08-15Warnings, Adverse reactionsExact identifier
rxcui: 1091839
unii: 0P6C6ZOP5U
RoflumilastROFLUMILASTZydus Lifesciences Limitede87287bd-eae3-46c3-9072-04800aeabf402024-08-12Exact identifier
rxcui: 2001319
rxcui: 1091839
unii: 0P6C6ZOP5U
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
RoflumilastROFLUMILASTCamber Pharmaceuticals, Inc.f25a0230-3cf6-4366-bebe-0ea5ff8de5ab2023-04-28Warnings, Adverse reactionsExact identifier
rxcui: 2001319
rxcui: 1091839
unii: 0P6C6ZOP5U
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
unii: 6OZP39ZG8H
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
unii: 6OZP39ZG8H
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
unii: 6OZP39ZG8H
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: 6OZP39ZG8H
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: 6OZP39ZG8H
ROFLUMILASTROFLUMILASTSolco Healthcare US, LLC.4251c764-7224-4f94-9de7-b6c76cb1f5cd2022-05-10Warnings, Adverse reactionsExact identifier
rxcui: 1091839
unii: 0P6C6ZOP5U
DalirespROFLUMILASTAstraZeneca Pharmaceuticals LPc9a1d0a8-581f-4f91-a2b8-f419192d0ebf2020-03-12Warnings, Adverse reactionsExact identifier
rxcui: 2001319
rxcui: 1091839
unii: 0P6C6ZOP5U

Reported adverse events (FAERS/openFDA)#

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