FDA.reportPublic FDA data

NDC 67877-730-32 - 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
67877-730
Requested NDC
67877-730-32
Package NDCs from labels
67877-730-30, 67877-730-90, 67877-730-05, 67877-730-32, 67877-730-93, 67877-730-87
Manufacturer
Ascend Laboratories, LLC | Alkem Laboratories Limited
Effective date
2025-03-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Roflumilast - Ascend Laboratories, LLC | Alkem Laboratories LimitedAscend Laboratories, LLC | Alkem Laboratories Limited2025-03-13Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-730-05Roflumilast500 in 1 BOTTLETABLET5005
67877-730-30Roflumilast30 in 1 BOTTLETABLET305
67877-730-32Roflumilast7 in 1 BLISTER PACKTABLET75
67877-730-87Roflumilast28 in 1 BLISTER PACKTABLET285
67877-730-87Roflumilast1 in 1 CARTONTABLET15
67877-730-90Roflumilast90 in 1 BOTTLETABLET905
67877-730-93Roflumilast4 in 1 CARTONTABLET45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-730ROFLUMILAST TABLET [ASCEND LABORATORIES, LLC]5Current NDC, 7 package rows20250316_93d72a99-64dc-4fde-a5b8-78331fa60787.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-730-32EA - Each67877-7300c341040-18f7-49f2-8df7-bc7005e750e712025-05-14
67877-730-93EA - Each67877-730cb7cdecf-3883-4456-a05d-3f8c6f9828c712025-05-14

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.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
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
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
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
application number: ANDA212490
rxcui: 1091839
unii: 0P6C6ZOP5U
RoflumilastROFLUMILASTAscend Laboratories, LLC93d72a99-64dc-4fde-a5b8-78331fa607872025-03-13Warnings, Adverse reactionsExact identifier
application number: ANDA212490
ndc (package): 67877-730-90
ndc (package): 67877-480-90
ndc (package): 67877-730-32
ndc (package): 67877-730-30
ndc (package): 67877-480-33
ndc (package): 67877-480-05
ndc (package): 67877-730-05
ndc (package): 67877-730-87
ndc (package): 67877-480-30
ndc (package): 67877-730-93
ndc (product): 67877-480
ndc (product): 67877-730
ndc11 (package): 67877073032
rxcui: 2001319
rxcui: 1091839
spl id: 955dd6eb-46f6-4c73-bcc8-bfd7b14ebc98
spl set id: 93d72a99-64dc-4fde-a5b8-78331fa60787
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
rxcui: 1091839
unii: 0P6C6ZOP5U
RoflumilastROFLUMILASTZydus Lifesciences Limitede87287bd-eae3-46c3-9072-04800aeabf402024-08-12Exact identifier
rxcui: 2001319
rxcui: 1091839
unii: 0P6C6ZOP5U

Reported adverse events (FAERS/openFDA)#

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