diclofenac sodium

Generic: diclofenac sodium

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

diclofenac sodium 50 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-467
Product ID 43063-467_36b10951-087f-5f3d-e063-6294a90a502e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074514
Listing Expiration 2026-12-31
Marketing Start 1996-03-26

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 43063467
Hyphenated Format 43063-467

Supplemental Identifiers

RxCUI
855906
UPC
0343063467305
UNII
QTG126297Q

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 sodium (source: ndc)
Generic Name diclofenac sodium (source: ndc)
Application Number ANDA074514 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 10 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-10)
  • 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-14)
  • 15 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-15)
  • 20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-20)
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-30)
source: ndc

Packages (5)

43063-467-10 10 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-10) 43063-467-14 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-14) 43063-467-15 15 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-15) 43063-467-20 20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-20) 43063-467-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-30)

Ingredients (1)

diclofenac sodium (50 mg/1)

Linked Drug Pages (1)

Diclofenac Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "36b10951-087f-5f3d-e063-6294a90a502e", "openfda": {"upc": ["0343063467305"], "unii": ["QTG126297Q"], "rxcui": ["855906"], "spl_set_id": ["663a3dbc-a631-4046-8852-ec619c41c81d"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-10)", "package_ndc": "43063-467-10", "marketing_start_date": "20130823"}, {"sample": false, "description": "14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-14)", "package_ndc": "43063-467-14", "marketing_start_date": "20130823"}, {"sample": false, "description": "15 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-15)", "package_ndc": "43063-467-15", "marketing_start_date": "20130823"}, {"sample": false, "description": "20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-20)", "package_ndc": "43063-467-20", "marketing_start_date": "20130823"}, {"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-30)", "package_ndc": "43063-467-30", "marketing_start_date": "20130823"}], "brand_name": "Diclofenac Sodium", "product_id": "43063-467_36b10951-087f-5f3d-e063-6294a90a502e", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "43063-467", "generic_name": "Diclofenac Sodium", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "50 mg/1"}], "application_number": "ANDA074514", "marketing_category": "ANDA", "marketing_start_date": "19960326", "listing_expiration_date": "20261231"}