diclofenac sodium topical solution (72189-546)

Drug Facts

Product Profile

Brand Name diclofenac sodium topical solution

Generic Name diclofenac sodium topical solution

Labeler direct_rx

Dosage Form SOLUTION

Routes

TOPICAL

Active Ingredients

diclofenac sodium 20 mg/g

Manufacturer

Direct_Rx

Identifiers & Regulatory

Product NDC 72189-546

Product ID 72189-546_15c2cd6d-b7c3-d927-e063-6394a90aa63e

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA213040

Listing Expiration 2026-12-31

Marketing Start 2024-04-10

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 72189546

Hyphenated Format 72189-546

Supplemental Identifiers

RxCUI

1487074

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 topical solution (source: ndc)

Generic Name diclofenac sodium topical solution (source: ndc)

Application Number ANDA213040 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

20 mg/g

source: ndc

Packaging

112 g in 1 BOTTLE (72189-546-04)

source: ndc

Packages (1)

72189-546-04 112 g in 1 BOTTLE (72189-546-04)

Ingredients (1)

diclofenac sodium (20 mg/g)

Linked Drug Pages (1)

Diclofenac Sodium Topical Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["TOPICAL"], "spl_id": "15c2cd6d-b7c3-d927-e063-6394a90aa63e", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["1487074"], "spl_set_id": ["15c2cd6d-b7c2-d927-e063-6394a90aa63e"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "112 g in 1 BOTTLE (72189-546-04)", "package_ndc": "72189-546-04", "marketing_start_date": "20240410"}], "brand_name": "Diclofenac Sodium Topical Solution", "product_id": "72189-546_15c2cd6d-b7c3-d927-e063-6394a90aa63e", "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": "72189-546", "generic_name": "Diclofenac Sodium Topical Solution", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium Topical Solution", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "20 mg/g"}], "application_number": "ANDA213040", "marketing_category": "ANDA", "marketing_start_date": "20240410", "listing_expiration_date": "20261231"}