diclofenac sodium

Generic: diclofenac sodium

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler direct_rx
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

diclofenac sodium 16.05 mg/mL

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-454
Product ID 72189-454_2c4dce0f-f071-feda-e063-6394a90a30ca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203818
Listing Expiration 2026-12-31
Marketing Start 2023-03-29

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 72189454
Hyphenated Format 72189-454

Supplemental Identifiers

RxCUI
857700
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 ANDA203818 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 16.05 mg/mL
source: ndc
Packaging
  • 150 mL in 1 CARTON (72189-454-05)
source: ndc

Packages (1)

72189-454-05 150 mL in 1 CARTON (72189-454-05)

Ingredients (1)

diclofenac sodium (16.05 mg/mL)

Linked Drug Pages (1)

Diclofenac Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2c4dce0f-f071-feda-e063-6394a90a30ca", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["857700"], "spl_set_id": ["f80b0b95-f4da-2d6c-e053-6294a90acf92"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "150 mL in 1 CARTON (72189-454-05)", "package_ndc": "72189-454-05", "marketing_start_date": "20230329"}], "brand_name": "Diclofenac Sodium", "product_id": "72189-454_2c4dce0f-f071-feda-e063-6394a90a30ca", "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": "72189-454", "generic_name": "Diclofenac Sodium", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "16.05 mg/mL"}], "application_number": "ANDA203818", "marketing_category": "ANDA", "marketing_start_date": "20230329", "listing_expiration_date": "20261231"}