diclofenac potassium

Generic: diclofenac potassium

Labeler: amici pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac potassium
Generic Name diclofenac potassium
Labeler amici pharma inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diclofenac potassium 50 mg/1

Manufacturer
Amici Pharma Inc.

Identifiers & Regulatory

Product NDC 69292-550
Product ID 69292-550_cf4973de-8da2-4fdf-8f48-938627e09d5a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076561
Listing Expiration 2026-12-31
Marketing Start 2020-12-11

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 69292550
Hyphenated Format 69292-550

Supplemental Identifiers

RxCUI
855942 857702
UPC
0369292548301
UNII
L4D5UA6CB4

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 diclofenac potassium (source: ndc)
Generic Name diclofenac potassium (source: ndc)
Application Number ANDA076561 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69292-550-01)
source: ndc

Packages (1)

69292-550-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69292-550-01)

Ingredients (1)

diclofenac potassium (50 mg/1)

Linked Drug Pages (1)

Diclofenac Potassium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cf4973de-8da2-4fdf-8f48-938627e09d5a", "openfda": {"upc": ["0369292548301"], "unii": ["L4D5UA6CB4"], "rxcui": ["855942", "857702"], "spl_set_id": ["f2908870-a517-491f-8771-4100d11b4b64"], "manufacturer_name": ["Amici Pharma Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69292-550-01)", "package_ndc": "69292-550-01", "marketing_start_date": "20201211"}], "brand_name": "Diclofenac Potassium", "product_id": "69292-550_cf4973de-8da2-4fdf-8f48-938627e09d5a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69292-550", "generic_name": "diclofenac potassium", "labeler_name": "Amici Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Potassium", "active_ingredients": [{"name": "DICLOFENAC POTASSIUM", "strength": "50 mg/1"}], "application_number": "ANDA076561", "marketing_category": "ANDA", "marketing_start_date": "20201211", "listing_expiration_date": "20261231"}