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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RoflumilastROFLUMILASTCamber Pharmaceuticals, Inc.f25a0230-3cf6-4366-bebe-0ea5ff8de5ab2023-04-28Warnings, Adverse reactionsExact identifier
rxcui: 2001319
rxcui: 1091839
unii: 0P6C6ZOP5U
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.