diclofenac sodium

Generic: diclofenac sodium

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler proficient rx lp
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

diclofenac sodium 75 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-012
Product ID 63187-012_4cdae2ee-c739-48aa-96e9-9ce517e10149
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077863
Listing Expiration 2026-12-31
Marketing Start 2008-08-19

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 63187012
Hyphenated Format 63187-012

Supplemental Identifiers

RxCUI
855926
UPC
0363187012304
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 ANDA077863 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 15 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-012-15)
  • 20 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-012-20)
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-012-30)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-012-60)
source: ndc

Packages (4)

63187-012-15 15 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-012-15) 63187-012-20 20 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-012-20) 63187-012-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-012-30) 63187-012-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-012-60)

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": "4cdae2ee-c739-48aa-96e9-9ce517e10149", "openfda": {"upc": ["0363187012304"], "unii": ["QTG126297Q"], "rxcui": ["855926"], "spl_set_id": ["1eb7a7bb-c524-4168-8ade-4601dc11533b"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-012-15)", "package_ndc": "63187-012-15", "marketing_start_date": "20191122"}, {"sample": false, "description": "20 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-012-20)", "package_ndc": "63187-012-20", "marketing_start_date": "20161101"}, {"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-012-30)", "package_ndc": "63187-012-30", "marketing_start_date": "20140401"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-012-60)", "package_ndc": "63187-012-60", "marketing_start_date": "20141001"}], "brand_name": "Diclofenac Sodium", "product_id": "63187-012_4cdae2ee-c739-48aa-96e9-9ce517e10149", "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": "63187-012", "generic_name": "Diclofenac Sodium", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "75 mg/1"}], "application_number": "ANDA077863", "marketing_category": "ANDA", "marketing_start_date": "20080819", "listing_expiration_date": "20261231"}