zipsor

Generic: diclofenac potassium

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

Drug Facts

Product Profile

Brand Name zipsor
Generic Name diclofenac potassium
Labeler assertio therapeutics, inc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

diclofenac potassium 25 mg/1

Manufacturer
Assertio Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 13913-008
Product ID 13913-008_73f6a60d-3089-4936-84df-8c28c49cb441
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022202
Listing Expiration 2026-12-31
Marketing Start 2009-06-16

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 13913008
Hyphenated Format 13913-008

Supplemental Identifiers

RxCUI
858342 858346
UPC
0313913008125
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 zipsor (source: ndc)
Generic Name diclofenac potassium (source: ndc)
Application Number NDA022202 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (13913-008-12)
source: ndc

Packages (1)

13913-008-12 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (13913-008-12)

Ingredients (1)

diclofenac potassium (25 mg/1)

Linked Drug Pages (1)

ZIPSOR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "73f6a60d-3089-4936-84df-8c28c49cb441", "openfda": {"upc": ["0313913008125"], "unii": ["L4D5UA6CB4"], "rxcui": ["858342", "858346"], "spl_set_id": ["c982eca0-fc41-11e1-a9c8-0002a5d5c51b"], "manufacturer_name": ["Assertio Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE, LIQUID FILLED in 1 BOTTLE (13913-008-12)", "package_ndc": "13913-008-12", "marketing_start_date": "20151201"}], "brand_name": "ZIPSOR", "product_id": "13913-008_73f6a60d-3089-4936-84df-8c28c49cb441", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "13913-008", "generic_name": "diclofenac potassium", "labeler_name": "Assertio Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZIPSOR", "active_ingredients": [{"name": "DICLOFENAC POTASSIUM", "strength": "25 mg/1"}], "application_number": "NDA022202", "marketing_category": "NDA", "marketing_start_date": "20090616", "listing_expiration_date": "20261231"}