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 2 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac PotassiumDICLOFENAC POTASSIUMSOLA Pharmaceuticals, LLCe770efc8-bbad-4103-98e4-e31019a540f52026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMNorthwind Health Company, LLCf2b6a4dd-e4e2-4acc-e053-2995a90aebf22026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUMNivagen Pharmaceuticals, Inc.eb52a015-23cd-40f6-bf83-6749fc34947c2025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859063
unii: L4D5UA6CB4
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM, FILM COATEDINA Pharmaceutics Inc,6c703075-b9a3-42de-87f6-fd1e1ef4b2e32025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMChartwell RX, LLC3a837a3e-10b2-4256-b515-80c863318ccb2025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUM TABLETSNIVAGEN PHARMACEUTICALS, INC.1f06a404-07c3-4414-8c5c-357c01d6ccb32025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMSOLA Pharmaceuticals, LLC26bf3a4a-42c6-cb59-e063-6394a90abd8b2025-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Alka-Seltzer GoldALKA-SELTZER GOLDBayer HealthCare LLC.0824bedb-413b-2fa0-e054-00144ff88e882025-12-04WarningsExact identifier
unii: HM5Z15LEBN
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
Diclofenac PotassiumDICLOFENAC POTASSIUMDoc Rx6394ab5f-b3ff-4397-97eb-ff92485c5ec02025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Diclofenac PotassiumDICLOFENAC POTASSIUMPhoenix RX LLC3fd418ac-49f6-d520-e063-6394a90afbd82025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Diclofenac PotassiumDICLOFENAC POTASSIUMIngenus Pharmaceuticals, LLC6926444f-0dca-4aeb-812e-755a83b149f42025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM, FILM COATEDGolden State Medical Supply, Inc.26d0ed73-b7a6-cbd8-e063-6394a90a9a312025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMTrifluent Pharma LLC8fdb1036-c0d8-4288-ac37-6512b05672ef2025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM, FILM COATEDHappy Robin, LLC3f91023f-9db9-88ba-e063-6394a90abd442025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4
Diclofenac PotassiumDICLOFENAC POTASSIUMINA Pharmaceutics Inc5ecd99fe-cb74-4a65-9636-2aefd2416ece2025-10-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L4D5UA6CB4

Reported adverse events (FAERS/openFDA)#

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