diclofenac sodium

Generic: diclofenac

Labeler: phoenix rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac
Labeler phoenix rx llc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

diclofenac sodium 16.05 mg/mL

Manufacturer
PHOENIX RX LLC

Identifiers & Regulatory

Product NDC 85509-1911
Product ID 85509-1911_41daa6f6-41c5-b81e-e063-6394a90a7516
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206116
Listing Expiration 2026-12-31
Marketing Start 2016-09-02

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 855091911
Hyphenated Format 85509-1911

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 (source: ndc)
Application Number ANDA206116 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 16.05 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (85509-1911-1) / 150 mL in 1 BOTTLE
source: ndc

Packages (1)

85509-1911-1 1 BOTTLE in 1 CARTON (85509-1911-1) / 150 mL in 1 BOTTLE

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": "41daa6f6-41c5-b81e-e063-6394a90a7516", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["857700"], "spl_set_id": ["41dab520-5651-a4c5-e063-6394a90a2962"], "manufacturer_name": ["PHOENIX RX LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (85509-1911-1)  / 150 mL in 1 BOTTLE", "package_ndc": "85509-1911-1", "marketing_start_date": "20251023"}], "brand_name": "Diclofenac Sodium", "product_id": "85509-1911_41daa6f6-41c5-b81e-e063-6394a90a7516", "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": "85509-1911", "generic_name": "Diclofenac", "labeler_name": "PHOENIX RX LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "16.05 mg/mL"}], "application_number": "ANDA206116", "marketing_category": "ANDA", "marketing_start_date": "20160902", "listing_expiration_date": "20261231"}