Cambia

Product NDC
13913-012
11-digit product format
139130012
Labeler code
13913
Product ID
13913-012_b9a3d927-3dc3-4860-ac3b-3dd20df47dd6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac potassium
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Assertio Therapeutics, Inc.
Application
NDA022165
Marketing category
NDA
Marketing start
2016-03-10
Substance
DICLOFENAC POTASSIUM
Active strength
50 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cambia
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC POTASSIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL4D5UA6CB4
Rxcui859063, 859066

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859066CAMBIA 50 MG Powder for Oral SolutionPSNd249ced1-4ca0-4f57-adcb-23440f58f6599
859063diclofenac potassium 50 MG Powder for Oral SolutionPSNd249ced1-4ca0-4f57-adcb-23440f58f6599
859066diclofenac potassium 50 MG Powder for Oral Solution [Cambia]SBDd249ced1-4ca0-4f57-adcb-23440f58f6599
859063diclofenac potassium 50 MG Powder for Oral SolutionSCDd249ced1-4ca0-4f57-adcb-23440f58f6599
859066Cambia 50 MG Powder for Oral SolutionSYd249ced1-4ca0-4f57-adcb-23440f58f6599
859063Diclofenac K+ 50 MG Powder for Oral SolutionSYd249ced1-4ca0-4f57-adcb-23440f58f6599
859066Diclofenac K+ 50 MG Powder for Oral Solution [Cambia]SYd249ced1-4ca0-4f57-adcb-23440f58f6599
859063Diclofenac Pot 50 MG Powder for Oral SolutionSYd249ced1-4ca0-4f57-adcb-23440f58f6599
859066Diclofenac Pot 50 MG Powder for Oral Solution [Cambia]SYd249ced1-4ca0-4f57-adcb-23440f58f6599

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13913-012-01139130012011 in 1 PACKETHistorical
13913-012-02139130012029 PACKET in 1 CARTON (13913-012-02) / 1 POWDER, FOR SOLUTION in 1 PACKET9 packet2016-03-100000-00-00NoNoCurrent
13913-012-03139130012039 PACKET in 1 CARTON (13913-012-03) / 1 POWDER, FOR SOLUTION in 1 PACKET (13913-012-01) 9 packet2016-03-100000-00-00NoNoCurrent