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 4 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac PotassiumDICLOFENAC POTASSIUMTeva Pharmaceuticals USA, Inc.77b60a0c-e49a-4ad4-abb1-b662c24ab7822024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMArchis Pharma LLC0d83cab3-c698-4763-9e77-27d72ba94e302024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMAdvanced Rx of Tennessee, LLC295d167c-eb56-8e14-e063-6394a90ad3252024-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMAdvanced Rx of Tennessee, LLC295d5dab-8890-d76e-e063-6394a90ad4022024-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM, FILM COATEDCintex Services, LLC0cdea9d3-fada-b00e-e063-6394a90ad5d92024-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
CambiaDICLOFENAC POTASSIUMAssertio Therapeutics, Inc.d249ced1-4ca0-4f57-adcb-23440f58f6592024-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA022165
ndc (package): 13913-012-03
ndc (package): 13913-012-01
ndc (package): 13913-012-02
ndc (product): 13913-012
ndc11 (package): 13913001201
rxcui: 859066
rxcui: 859063
spl id: b9a3d927-3dc3-4860-ac3b-3dd20df47dd6
spl set id: d249ced1-4ca0-4f57-adcb-23440f58f659
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMAurobindo Pharma Limited7efdbe23-503a-4f38-a0b6-c003033f0de72024-12-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMNuCare Pharmaceuticals, Inc.26a8f723-2a8e-8a5a-e063-6394a90a7bae2024-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMNuCare Pharmaceuticals, Inc.3da9e463-1b2f-54c0-e054-00144ff88e882024-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
LOFENADICLOFENAC POTASSIUMCarwin Pharmaceutical Associates, LLC49bd64cc-5edb-44f2-8e24-1249f6a766632024-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUMLeading Pharma, LLC9dd418b2-4b0e-498c-b453-f580c69ddc6d2024-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA022165
rxcui: 859063
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMA-S Medication Solutions112e7c94-23c8-451e-ae71-eb89a6eb2cb22023-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMCarwin Pharmaceutical Associates, LLCbce95bb3-3097-4e7d-8d29-0870bb7292122023-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUM TABLETSA-S Medication Solutions5d37fc5a-7a2f-432e-b4e9-e00c246ce33c2023-10-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMBryant Ranch Prepack717341fc-e067-0005-215c-053f6d12e0d12023-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMProficient Rx LP94586867-c75b-4d60-be1d-03a9e4b7cd102023-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM, FILM COATEDHavix Group Inc d-b-a Aavis Pharmaceuticals30ab7b30-cc90-4b84-8caf-21058f1d37fa2023-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A

Reported adverse events (FAERS/openFDA)#

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