FDA.reportPublic FDA data

NDC 67877-772-49 - Diclofenac Potassium

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
67877-772
Requested NDC
67877-772-49
Package NDCs from labels
67877-772-49, 67877-772-58
Manufacturer
Ascend Laboratories, LLC | Alkem Laboratories Limited
Effective date
2022-10-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diclofenac Potassium - Ascend Laboratories, LLC | Alkem Laboratories LimitedAscend Laboratories, LLC | Alkem Laboratories Limited2022-10-21Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-772-49Diclofenac Potassium1 in 1 PACKETPOWDER, FOR SOLUTION14
67877-772-58Diclofenac Potassium9 in 1 CARTONPOWDER, FOR SOLUTION94

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-772DICLOFENAC POTASSIUM POWDER, FOR SOLUTION [ASCEND LABORATORIES, LLC]4Current NDC, Legacy NDC, 2 package rows20221024_f675a627-c944-4ec6-8c08-b5fdb78dc269.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-772-49EA - Each67877-772bb9c383d-860e-4283-8a2a-9a19e5bb420512023-02-06
67877-772-58EA - Each67877-7725498d971-1ec4-417f-b7ee-639b39e5964a12023-01-09

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 5 · 89 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM, FILM COATEDAmerisyn LLCb0931350-28a9-4f00-9254-1d72e31f04c32026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMPar Health USA, LLC2d45648f-cbea-41a4-8e3e-007b7bb7912c2026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859063
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMSun Pharmaceutical Industries, Inc.68a926a2-b818-420f-9c9a-fd91dc5a8f362026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859063
unii: L4D5UA6CB4
diclofenac potassiumDICLOFENAC POTASSIUMStrides Pharma Science Limited2184805c-b9b3-4be8-8726-4ce1b11974772026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMREMEDYREPACK INC.c4976d69-ca06-4263-9240-6fd8b44a9b6d2026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMNuCare Pharmaceuticals,Inc.d61cbb27-737d-948c-e053-2a95a90adaca2026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM, FILM COATEDVICI Pharmaceuticals, Inc544a869e-60ef-627b-e063-6294a90a3fd82026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMBryant Ranch Prepack86461915-9bc1-43d4-8d92-6eef3e56bd902026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMBryant Ranch Prepacke29e7aea-0bcd-46e5-b011-fbaf5aa2244a2026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Diclofenac PotassiumDICLOFENAC POTASSIUM TABLETSUmedica Laboratories USA Inc.1fa07fbe-3708-4200-b3ff-a920434896b62026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUM 25 MGPureTek Corporation4a828eb5-0383-f524-e063-6394a90a84492026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUM TABLETSBryant Ranch Prepack94898228-c595-4fd6-acc2-13dbdbde9c0e2026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUMTorrent Pharmaceuticals Limited6a945fa8-6c62-40ba-ae97-b994cc90583e2026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859063
unii: L4D5UA6CB4
ZIPSORDICLOFENAC POTASSIUMAssertio Specialty Pharmaceuticals LLCed2a8868-78eb-47b8-8f46-0f70e2891e072026-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUMUmedica Laboratories USA Inc.33930285-dd97-415c-9e2a-491bd7b12af92026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859063
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMAvKARE21dc9953-4e6d-50f0-e063-6294a90ac4ef2026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMPHOENIX RX LLC43448b74-6c02-a581-e063-6394a90a63ba2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Artificial Sweetener Detox 6034ARTIFICIAL SWEETENER DETOXProfessional Complementary Health Formulas38f2ae0b-2b1f-4b49-934d-fe1556f84d932026-01-08WarningsExact identifier
unii: 96K6UQ3ZD4
Diclofenac PotassiumDICLOFENAC POTASSIUM TABLETSZydus Pharmaceuticals (USA) Inc.1aa3d8d6-dd1c-46c7-96f9-2b5c9d72764a2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4

Reported adverse events (FAERS/openFDA)#

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