FDA.reportPublic FDA data

NDC 72162-2385-03 - 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
72162-2385
Requested NDC
72162-2385-03
Package NDCs from labels
72162-2385-3, 72162-2385-03
Manufacturer
Bryant Ranch Prepack
Effective date
2024-08-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ROFLUMILAST - Bryant Ranch PrepackBryant Ranch Prepack2024-08-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2385-3ROFLUMILAST30 in 1 BOTTLETABLET30100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2385ROFLUMILAST TABLET [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240816_fa9c3bea-a04d-4ea9-ade9-ee8d9f6b1f72.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2385-3EA - Each72162-2385f5ea082d-3408-43a6-bea0-9315162d26a812024-11-05

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 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
ZORYVEROFLUMILASTArcutis Biotherapeutics, Inc.f9e0b4a9-a227-4947-b00c-41fb18d165892026-06-22Warnings, Adverse reactionsExact identifier
unii: 0P6C6ZOP5U
ROFLUMILASTROFLUMILASTAmici Pharma Inc.cb3781ff-5350-4f9a-b247-0b04eb0f2b922026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 2001319
rxcui: 1091839
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
rxcui: 1091839
unii: 0P6C6ZOP5U
RoflumilastROFLUMILASTMAJOR PHARMACEUTICALSc51b80f3-a591-4db9-81b4-b91603e35d7c2025-12-04Warnings, Adverse reactionsExact identifier
rxcui: 2001319
rxcui: 1091839
unii: 0P6C6ZOP5U
ROFLUMILASTROFLUMILASTMicro Labs Limiteddc2a689f-cfa4-4863-9623-a9813dcf86a92025-07-24Warnings, Adverse reactionsExact identifier
application number: ANDA208180
ndc (product): 42571-259
rxcui: 2001319
rxcui: 1091839
spl id: 3aacb2a6-70a4-650d-e063-6394a90af9fc
spl set id: dc2a689f-cfa4-4863-9623-a9813dcf86a9
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
RoflumilastROFLUMILASTNovadoz Pharmaceuticals LLC4d25f69c-58b7-4e2a-b835-4d0c76a83c7c2024-08-27Warnings, Adverse reactionsExact identifier
rxcui: 2001319
rxcui: 1091839
unii: 0P6C6ZOP5U
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
application number: ANDA208180
ndc (package): 72162-2385-3
ndc (product): 72162-2385
ndc11 (package): 72162238503
rxcui: 1091839
spl id: f086d8f9-3cf8-4196-a422-c4117bd1fcaf
spl set id: fa9c3bea-a04d-4ea9-ade9-ee8d9f6b1f72
unii: 0P6C6ZOP5U
RoflumilastROFLUMILASTZydus Lifesciences Limitede87287bd-eae3-46c3-9072-04800aeabf402024-08-12Exact identifier
rxcui: 2001319
rxcui: 1091839
unii: 0P6C6ZOP5U