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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
13913-012-01	Cambia	1 in 1 PACKET	POWDER, FOR SOLUTION	1	9
13913-012-02	Cambia	1 in 1 PACKET	POWDER, FOR SOLUTION	1	9
13913-012-02	Cambia	9 in 1 CARTON	POWDER, FOR SOLUTION	9	9
13913-012-03	Cambia	9 in 1 CARTON	POWDER, FOR SOLUTION	9	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13913-012	CAMBIA (DICLOFENAC POTASSIUM) POWDER, FOR SOLUTION [ASSERTIO THERAPEUTICS, INC.]	9	Current NDC, Legacy NDC, 4 package rows	20241215_d249ced1-4ca0-4f57-adcb-23440f58f659.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13913-012-01	EA - Each	13913-012	a4afaf38-fa08-4e82-ae9a-1cfd685736fb	1	2016-11-08
13913-012-03	EA - Each	13913-012	c3596580-b003-4c2f-aa16-8cf4a3bbad33	1	2016-11-08

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 5 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Potassium	DICLOFENAC POTASSIUM	Ascend Laboratories, LLC	f675a627-c944-4ec6-8c08-b5fdb78dc269	2022-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 859063 unii: L4D5UA6CB4
Effer-K Orange	POTASSIUM BICARBONATE	Nomax Inc.	bd402d91-d28d-49e9-9c1d-0983854773b3	2019-12-23	Warnings, Adverse reactions	Exact identifier unii: HM5Z15LEBN
Effer-K 20 mEq Unflavored	POTASSIUM BICARBONATE	Nomax Inc.	8869554b-ff0b-4f0e-8a09-61e7be3b496e	2019-12-18	Warnings, Adverse reactions	Exact identifier unii: HM5Z15LEBN

Reported adverse events (FAERS/openFDA)#

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