diclofenac potassium

Generic: diclofenac potassium

Labeler: marlex pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

diclofenac potassium 50 mg/1

Manufacturer
Marlex Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 10135-806
Product ID 10135-806_30c7197b-7111-d8a7-e063-6394a90addfb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075463
Listing Expiration 2026-12-31
Marketing Start 2025-03-01

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 10135806
Hyphenated Format 10135-806

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 (source: ndc)
Application Number ANDA075463 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-806-01)
source: ndc

Packages (1)

10135-806-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-806-01)

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": "30c7197b-7111-d8a7-e063-6394a90addfb", "openfda": {"unii": ["L4D5UA6CB4"], "rxcui": ["855942"], "spl_set_id": ["30c7197b-7110-d8a7-e063-6394a90addfb"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-806-01)", "package_ndc": "10135-806-01", "marketing_start_date": "20250301"}], "brand_name": "Diclofenac Potassium", "product_id": "10135-806_30c7197b-7111-d8a7-e063-6394a90addfb", "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": "10135-806", "generic_name": "diclofenac potassium", "labeler_name": "Marlex Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Potassium", "active_ingredients": [{"name": "DICLOFENAC POTASSIUM", "strength": "50 mg/1"}], "application_number": "ANDA075463", "marketing_category": "ANDA", "marketing_start_date": "20250301", "listing_expiration_date": "20261231"}