diclofenac sodium

Generic: diclofenac sodium

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

diclofenac sodium 50 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-068
Product ID 71610-068_dc9b6499-7a34-4757-86b2-0880f3288048
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074514
Listing Expiration 2026-12-31
Marketing Start 2015-07-27

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 71610068
Hyphenated Format 71610-068

Supplemental Identifiers

RxCUI
855906
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
  • 180 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-068-80)
source: ndc

Packages (1)

71610-068-80 180 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-068-80)

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": "dc9b6499-7a34-4757-86b2-0880f3288048", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855906"], "spl_set_id": ["e4af374a-1281-46af-a0a9-48820db6c947"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-068-80)", "package_ndc": "71610-068-80", "marketing_start_date": "20180514"}], "brand_name": "Diclofenac Sodium", "product_id": "71610-068_dc9b6499-7a34-4757-86b2-0880f3288048", "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": "71610-068", "generic_name": "Diclofenac Sodium", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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": "20150727", "listing_expiration_date": "20261231"}