diclofenac sodium

Generic: diclofenac sodium

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler asclemed usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diclofenac sodium 100 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-598
Product ID 76420-598_045ce619-2c60-e219-e063-6294a90a8cd5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216275
Listing Expiration 2026-12-31
Marketing Start 2022-09-26

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 76420598
Hyphenated Format 76420-598

Supplemental Identifiers

RxCUI
855657
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 ANDA216275 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-07)
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-10)
  • 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-14)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-90)
source: ndc

Packages (7)

76420-598-07 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-07) 76420-598-10 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-10) 76420-598-14 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-14) 76420-598-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-20) 76420-598-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-30) 76420-598-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-60) 76420-598-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-90)

Ingredients (1)

diclofenac sodium (100 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": "045ce619-2c60-e219-e063-6294a90a8cd5", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855657"], "spl_set_id": ["6a9c3cea-7b46-427d-99af-90c1f290b190"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-07)", "package_ndc": "76420-598-07", "marketing_start_date": "20230902"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-10)", "package_ndc": "76420-598-10", "marketing_start_date": "20230902"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-14)", "package_ndc": "76420-598-14", "marketing_start_date": "20230902"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-20)", "package_ndc": "76420-598-20", "marketing_start_date": "20230902"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-30)", "package_ndc": "76420-598-30", "marketing_start_date": "20230902"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-60)", "package_ndc": "76420-598-60", "marketing_start_date": "20230902"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-90)", "package_ndc": "76420-598-90", "marketing_start_date": "20230902"}], "brand_name": "Diclofenac sodium", "product_id": "76420-598_045ce619-2c60-e219-e063-6294a90a8cd5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "76420-598", "generic_name": "diclofenac sodium", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "100 mg/1"}], "application_number": "ANDA216275", "marketing_category": "ANDA", "marketing_start_date": "20220926", "listing_expiration_date": "20261231"}