diclofenac potassium

Generic: diclofenac potassium, film coated

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

Drug Facts

Product Profile

Brand Name diclofenac potassium
Generic Name diclofenac potassium, film coated
Labeler amici pharma, inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diclofenac potassium 50 mg/1

Manufacturer
Amici Pharma, Inc

Identifiers & Regulatory

Product NDC 69292-552
Product ID 69292-552_796bf62e-3eee-423f-9770-a2d436fe5064
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215787
Listing Expiration 2026-12-31
Marketing Start 2024-03-12

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 69292552
Hyphenated Format 69292-552

Supplemental Identifiers

RxCUI
855942
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 diclofenac potassium (source: ndc)
Generic Name diclofenac potassium, film coated (source: ndc)
Application Number ANDA215787 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69292-552-01)
  • 500 TABLET in 1 BOTTLE (69292-552-50)
source: ndc

Packages (2)

69292-552-01 100 TABLET in 1 BOTTLE (69292-552-01) 69292-552-50 500 TABLET in 1 BOTTLE (69292-552-50)

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": "796bf62e-3eee-423f-9770-a2d436fe5064", "openfda": {"unii": ["L4D5UA6CB4"], "rxcui": ["855942"], "spl_set_id": ["c4ce1497-9cb1-4632-b1a2-4f61043c018d"], "manufacturer_name": ["Amici Pharma, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69292-552-01)", "package_ndc": "69292-552-01", "marketing_start_date": "20240312"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69292-552-50)", "package_ndc": "69292-552-50", "marketing_start_date": "20240312"}], "brand_name": "DICLOFENAC POTASSIUM", "product_id": "69292-552_796bf62e-3eee-423f-9770-a2d436fe5064", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69292-552", "generic_name": "diclofenac potassium, film coated", "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": "ANDA215787", "marketing_category": "ANDA", "marketing_start_date": "20240312", "listing_expiration_date": "20261231"}