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 SOLUTION
Routes
OPHTHALMIC
Active Ingredients

diclofenac sodium 1 mg/mL

Manufacturer
Advagen Pharma Ltd

Identifiers & Regulatory

Product NDC 72888-150
Product ID 72888-150_34008387-2a5c-a02a-e063-6394a90a4c40
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077600
Listing Expiration 2026-12-31
Marketing Start 2025-04-30

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 72888150
Hyphenated Format 72888-150

Supplemental Identifiers

RxCUI
854801
UPC
0372888150222 0372888150215
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 ANDA077600 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (72888-150-21) / 2.5 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72888-150-22) / 5 mL in 1 BOTTLE
source: ndc

Packages (2)

Ingredients (1)

diclofenac sodium (1 mg/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["OPHTHALMIC"], "spl_id": "34008387-2a5c-a02a-e063-6394a90a4c40", "openfda": {"upc": ["0372888150222", "0372888150215"], "unii": ["QTG126297Q"], "rxcui": ["854801"], "spl_set_id": ["72419a68-4c9d-44e0-9b43-922440e2c8d7"], "manufacturer_name": ["Advagen Pharma Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (72888-150-21)  / 2.5 mL in 1 BOTTLE", "package_ndc": "72888-150-21", "marketing_start_date": "20250430"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72888-150-22)  / 5 mL in 1 BOTTLE", "package_ndc": "72888-150-22", "marketing_start_date": "20250430"}], "brand_name": "DICLOFENAC SODIUM", "product_id": "72888-150_34008387-2a5c-a02a-e063-6394a90a4c40", "dosage_form": "SOLUTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "72888-150", "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": "1 mg/mL"}], "application_number": "ANDA077600", "marketing_category": "ANDA", "marketing_start_date": "20250430", "listing_expiration_date": "20261231"}