diclofenac sodium

Generic: diclofenac sodium

Labeler: advagen pharma ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

diclofenac sodium 25 mg/1

Manufacturer
Advagen Pharma Ltd

Identifiers & Regulatory

Product NDC 72888-109
Product ID 72888-109_3904a832-bc2f-1d96-e063-6294a90a0cd0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216548
Listing Expiration 2026-12-31
Marketing Start 2023-05-11

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 72888109
Hyphenated Format 72888-109

Supplemental Identifiers

RxCUI
855664 855906 855926
UPC
0372888110608 0372888111001 0372888110059 0372888111056 0372888109015 0372888109008 0372888110301 0372888111308 0372888109602 0372888110004 0372888111605 0372888109053 0372888109305 0372888110011 0372888111018
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 ANDA216548 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-00)
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-01)
  • 500 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-05)
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-30)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-60)
source: ndc

Packages (5)

72888-109-00 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-00) 72888-109-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-01) 72888-109-05 500 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-05) 72888-109-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-30) 72888-109-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-60)

Ingredients (1)

diclofenac sodium (25 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": "3904a832-bc2f-1d96-e063-6294a90a0cd0", "openfda": {"upc": ["0372888110608", "0372888111001", "0372888110059", "0372888111056", "0372888109015", "0372888109008", "0372888110301", "0372888111308", "0372888109602", "0372888110004", "0372888111605", "0372888109053", "0372888109305", "0372888110011", "0372888111018"], "unii": ["QTG126297Q"], "rxcui": ["855664", "855906", "855926"], "spl_set_id": ["ac2b4060-a5da-4ddf-a734-2ff58a1f98c9"], "manufacturer_name": ["Advagen Pharma Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-00)", "package_ndc": "72888-109-00", "marketing_start_date": "20230601"}, {"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-01)", "package_ndc": "72888-109-01", "marketing_start_date": "20230601"}, {"sample": false, "description": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-05)", "package_ndc": "72888-109-05", "marketing_start_date": "20230801"}, {"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-30)", "package_ndc": "72888-109-30", "marketing_start_date": "20230601"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-60)", "package_ndc": "72888-109-60", "marketing_start_date": "20230601"}], "brand_name": "Diclofenac Sodium", "product_id": "72888-109_3904a832-bc2f-1d96-e063-6294a90a0cd0", "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": "72888-109", "generic_name": "Diclofenac Sodium", "labeler_name": "Advagen Pharma Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "25 mg/1"}], "application_number": "ANDA216548", "marketing_category": "ANDA", "marketing_start_date": "20230511", "listing_expiration_date": "20261231"}