diclofenac sodium

Generic: diclofenac sodium

Labeler: directrx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

diclofenac sodium 16.05 mg/mL

Manufacturer
DirectRx

Identifiers & Regulatory

Product NDC 72189-319
Product ID 72189-319_2c3d2dfe-0fee-b986-e063-6294a90a84c9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203818
Listing Expiration 2026-12-31
Marketing Start 2022-01-19

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 72189319
Hyphenated Format 72189-319

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 BOTTLE, DROPPER (72189-319-05)
source: ndc

Packages (1)

72189-319-05 150 mL in 1 BOTTLE, DROPPER (72189-319-05)

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": "2c3d2dfe-0fee-b986-e063-6294a90a84c9", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["857700"], "spl_set_id": ["d5f215d4-9aa3-2ecf-e053-2995a90a2e89"], "manufacturer_name": ["DirectRx"]}, "finished": true, "packaging": [{"sample": false, "description": "150 mL in 1 BOTTLE, DROPPER (72189-319-05)", "package_ndc": "72189-319-05", "marketing_start_date": "20220119"}], "brand_name": "DICLOFENAC SODIUM", "product_id": "72189-319_2c3d2dfe-0fee-b986-e063-6294a90a84c9", "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": "72189-319", "generic_name": "DICLOFENAC SODIUM", "labeler_name": "DirectRx", "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": "20220119", "listing_expiration_date": "20261231"}