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 75 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 55289-150
Product ID 55289-150_3466672c-1212-3459-e063-6294a90a1288
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 55289150
Hyphenated Format 55289-150

Supplemental Identifiers

RxCUI
855926
UPC
0355289150305
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
  • 75 mg/1
source: ndc
Packaging
  • 10 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-10)
  • 15 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-15)
  • 20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-20)
  • 28 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-28)
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-30)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-60)
source: ndc

Packages (6)

55289-150-10 10 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-10) 55289-150-15 15 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-15) 55289-150-20 20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-20) 55289-150-28 28 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-28) 55289-150-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-30) 55289-150-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-60)

Ingredients (1)

diclofenac sodium (75 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": "3466672c-1212-3459-e063-6294a90a1288", "openfda": {"upc": ["0355289150305"], "unii": ["QTG126297Q"], "rxcui": ["855926"], "spl_set_id": ["87d5a720-f154-4c4b-b2d4-0ae58455dda0"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-10)", "package_ndc": "55289-150-10", "marketing_start_date": "20110331"}, {"sample": false, "description": "15 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-15)", "package_ndc": "55289-150-15", "marketing_start_date": "20110331"}, {"sample": false, "description": "20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-20)", "package_ndc": "55289-150-20", "marketing_start_date": "20110331"}, {"sample": false, "description": "28 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-28)", "package_ndc": "55289-150-28", "marketing_start_date": "20110331"}, {"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-30)", "package_ndc": "55289-150-30", "marketing_start_date": "20110331"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-60)", "package_ndc": "55289-150-60", "marketing_start_date": "20110331"}], "brand_name": "Diclofenac Sodium", "product_id": "55289-150_3466672c-1212-3459-e063-6294a90a1288", "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": "55289-150", "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": "75 mg/1"}], "application_number": "ANDA074514", "marketing_category": "ANDA", "marketing_start_date": "19960326", "listing_expiration_date": "20261231"}