cambia

Generic: diclofenac potassium

Labeler: assertio therapeutics, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cambia
Generic Name diclofenac potassium
Labeler assertio therapeutics, inc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

diclofenac potassium 50 mg/1

Manufacturer
Assertio Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 13913-012
Product ID 13913-012_b9a3d927-3dc3-4860-ac3b-3dd20df47dd6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022165
Listing Expiration 2026-12-31
Marketing Start 2016-03-10

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] decreased prostaglandin production [pe] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13913012
Hyphenated Format 13913-012

Supplemental Identifiers

RxCUI
859063 859066
UNII
L4D5UA6CB4

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cambia (source: ndc)
Generic Name diclofenac potassium (source: ndc)
Application Number NDA022165 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 9 PACKET in 1 CARTON (13913-012-02) / 1 POWDER, FOR SOLUTION in 1 PACKET
  • 9 PACKET in 1 CARTON (13913-012-03) / 1 POWDER, FOR SOLUTION in 1 PACKET (13913-012-01)
source: ndc

Packages (2)

13913-012-02 9 PACKET in 1 CARTON (13913-012-02) / 1 POWDER, FOR SOLUTION in 1 PACKET 13913-012-03 9 PACKET in 1 CARTON (13913-012-03) / 1 POWDER, FOR SOLUTION in 1 PACKET (13913-012-01)

Ingredients (1)

diclofenac potassium (50 mg/1)

Linked Drug Pages (1)

Cambia ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b9a3d927-3dc3-4860-ac3b-3dd20df47dd6", "openfda": {"unii": ["L4D5UA6CB4"], "rxcui": ["859063", "859066"], "spl_set_id": ["d249ced1-4ca0-4f57-adcb-23440f58f659"], "manufacturer_name": ["Assertio Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "9 PACKET in 1 CARTON (13913-012-02)  / 1 POWDER, FOR SOLUTION in 1 PACKET", "package_ndc": "13913-012-02", "marketing_start_date": "20160310"}, {"sample": false, "description": "9 PACKET in 1 CARTON (13913-012-03)  / 1 POWDER, FOR SOLUTION in 1 PACKET (13913-012-01)", "package_ndc": "13913-012-03", "marketing_start_date": "20160310"}], "brand_name": "Cambia", "product_id": "13913-012_b9a3d927-3dc3-4860-ac3b-3dd20df47dd6", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "13913-012", "generic_name": "diclofenac potassium", "labeler_name": "Assertio Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cambia", "active_ingredients": [{"name": "DICLOFENAC POTASSIUM", "strength": "50 mg/1"}], "application_number": "NDA022165", "marketing_category": "NDA", "marketing_start_date": "20160310", "listing_expiration_date": "20261231"}