diclofenac sodium

Generic: diclofenac sodium

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler aurobindo pharma limited
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

diclofenac sodium 75 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-843
Product ID 59651-843_3487033c-7c62-4034-8718-73a7c49b26a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075281
Listing Expiration 2026-12-31
Marketing Start 2025-04-17

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 59651843
Hyphenated Format 59651-843

Supplemental Identifiers

RxCUI
855906 855926
UPC
0359651842607 0359651843604
UNII
QTG126297Q

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 sodium (source: ndc)
Generic Name diclofenac sodium (source: ndc)
Application Number ANDA075281 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-01)
  • 500 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-05)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-60)
  • 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-99)
source: ndc

Packages (4)

59651-843-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-01) 59651-843-05 500 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-05) 59651-843-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-60) 59651-843-99 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-99)

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": "3487033c-7c62-4034-8718-73a7c49b26a0", "openfda": {"upc": ["0359651842607", "0359651843604"], "unii": ["QTG126297Q"], "rxcui": ["855906", "855926"], "spl_set_id": ["3487033c-7c62-4034-8718-73a7c49b26a0"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-01)", "package_ndc": "59651-843-01", "marketing_start_date": "20250417"}, {"sample": false, "description": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-05)", "package_ndc": "59651-843-05", "marketing_start_date": "20250417"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-60)", "package_ndc": "59651-843-60", "marketing_start_date": "20250417"}, {"sample": false, "description": "1000 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-99)", "package_ndc": "59651-843-99", "marketing_start_date": "20250417"}], "brand_name": "DICLOFENAC SODIUM", "product_id": "59651-843_3487033c-7c62-4034-8718-73a7c49b26a0", "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": "59651-843", "generic_name": "DICLOFENAC SODIUM", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DICLOFENAC SODIUM", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "75 mg/1"}], "application_number": "ANDA075281", "marketing_category": "ANDA", "marketing_start_date": "20250417", "listing_expiration_date": "20261231"}