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 3 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac potassiumDICLOFENAC POTASSIUMTEVA PHARMACEUTICALS, INC.d9685883-9d0b-81da-e053-2a95a90ab8d82025-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
ZIPSORDICLOFENAC POTASSIUMAssertio Therapeutics, Inc.c982eca0-fc41-11e1-a9c8-0002a5d5c51b2025-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM, FILM COATEDAmici Pharma, Incc4ce1497-9cb1-4632-b1a2-4f61043c018d2025-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
KLOR-Con/EFPOTASSIUM BICARBONATEUpsher-Smith Laboratories, Inc.f9d85c4f-aa46-40b2-ad76-89dbf6ec8e4d2025-07-14Warnings, Adverse reactionsExact identifier
unii: HM5Z15LEBN
Diclofenac PotassiumDICLOFENAC POTASSIUMGolden State Medical Supply, Inc.c2c79af6-f35e-5cdf-e053-2a95a90a4d632025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMAmici Pharma Inc.f2908870-a517-491f-8771-4100d11b4b642025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Diclofenac PotassiumDICLOFENAC POTASSIUMLifsa Drugs LLC90a0539a-7227-4b91-8b22-25b6f23ef35f2025-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMPreferred Pharmaceuticals Inc.4f482f98-ef10-45d7-8e9f-9cf291d930922025-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMLeading Pharma, LLC698690a7-4978-4457-b123-0a670bbab4812025-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Aspartame/MSG DetoxCHELIDONIUM MAJUS, ARNICA MONTANA, PHYTOLACCA DECANDRA, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BISPHENOL A (BPA), DEXTROSE, MALTODEXTRIN, SUCRALOSE, ASPARTIC ACID, DIKETOPIPERAZINE, DOPAMINE HYDROCHLORIDE, FORMALINUM, FORMICUM ACIDUM, L-PHENYLALANINE, METHYL ALCOHOL, MONOSODIUM GLUTAMATEDeseret Biologicals, Inc.a1dc1bf3-db71-4550-a975-4f146fb940052025-03-11WarningsExact identifier
unii: 96K6UQ3ZD4
diclofenac potassiumDICLOFENAC POTASSIUMHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.d64537c8-e397-4d17-b95c-3092668260aa2025-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMPD-Rx Pharmaceuticals, Inc.08e41a9d-644c-4ac6-aba3-38d7c3f36d362025-03-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMMarlex Pharmaceuticals, Inc.30c7197b-7110-d8a7-e063-6394a90addfb2025-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMCoupler LLC2eead069-f954-abb2-e063-6394a90a14ff2025-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUM TABLETSNuCare Pharmaceuticals,Inc.ffc41543-a353-cade-e053-6294a90a99fb2025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac potassiumDICLOFENAC POTASSIUMCamber Pharmaceuticals, Inc.9261a9d6-f772-41a2-ac99-8608c04c355b2025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859063
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMBryant Ranch Prepack69ab6f91-5770-480c-8bd1-8c1f1f8bfdb52025-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac potassiumDICLOFENAC POTASSIUMBryant Ranch Prepack8c54e404-2dbd-49cd-8235-b2a708bae5632025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4

Reported adverse events (FAERS/openFDA)#

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