FDA.reportPublic FDA data

NDC 13913-012-01 - Cambia

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
13913-012
Requested NDC
13913-012-01
Package NDCs from labels
13913-012-01, 13913-012-03, 13913-012-02
Manufacturer
Assertio Therapeutics, Inc.
Effective date
2024-12-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cambia - Assertio Therapeutics, Inc.Assertio Therapeutics, Inc.2024-12-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13913-012-01Cambia1 in 1 PACKETPOWDER, FOR SOLUTION19
13913-012-02Cambia1 in 1 PACKETPOWDER, FOR SOLUTION19
13913-012-02Cambia9 in 1 CARTONPOWDER, FOR SOLUTION99
13913-012-03Cambia9 in 1 CARTONPOWDER, FOR SOLUTION99

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13913-012CAMBIA (DICLOFENAC POTASSIUM) POWDER, FOR SOLUTION [ASSERTIO THERAPEUTICS, INC.]9Current NDC, Legacy NDC, 4 package rows20241215_d249ced1-4ca0-4f57-adcb-23440f58f659.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13913-012-01EA - Each13913-012a4afaf38-fa08-4e82-ae9a-1cfd685736fb12016-11-08
13913-012-03EA - Each13913-012c3596580-b003-4c2f-aa16-8cf4a3bbad3312016-11-08

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 · 83 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.