diclofenac sodium

Generic: diclofenac sodium

Labeler: aurobindo pharma limited
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler aurobindo pharma limited
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 10 mg/g

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 84386-120
Product ID 84386-120_e5c0863a-edb7-4f46-a396-c9b2d8785cf8
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204306
Listing Expiration 2026-12-31
Marketing Start 2025-10-15

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 84386120
Hyphenated Format 84386-120

Supplemental Identifiers

RxCUI
855633
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 ANDA204306 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (84386-120-01) / 100 g in 1 TUBE
source: ndc

Packages (1)

84386-120-01 1 TUBE in 1 CARTON (84386-120-01) / 100 g in 1 TUBE

Ingredients (1)

diclofenac sodium (10 mg/g)

Linked Drug Pages (1)

Diclofenac Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "e5c0863a-edb7-4f46-a396-c9b2d8785cf8", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855633"], "spl_set_id": ["e5c0863a-edb7-4f46-a396-c9b2d8785cf8"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (84386-120-01)  / 100 g in 1 TUBE", "package_ndc": "84386-120-01", "marketing_start_date": "20251015"}], "brand_name": "Diclofenac Sodium", "product_id": "84386-120_e5c0863a-edb7-4f46-a396-c9b2d8785cf8", "dosage_form": "GEL", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "84386-120", "generic_name": "Diclofenac Sodium", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "10 mg/g"}], "application_number": "ANDA204306", "marketing_category": "ANDA", "marketing_start_date": "20251015", "listing_expiration_date": "20261231"}