diclofenac sodium

Generic: diclofenac sodium

Labeler: innovus pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler innovus pharmaceuticals, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 10 mg/g

Manufacturer
INNOVUS PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 57483-185
Product ID 57483-185_ad9d2c28-21bc-4f81-9c90-cce6a96d976a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204306
Listing Expiration 2026-12-31
Marketing Start 2025-03-25

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 57483185
Hyphenated Format 57483-185

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 (57483-185-11) / 150 g in 1 TUBE (57483-185-01)
source: ndc

Packages (1)

57483-185-11 1 TUBE in 1 CARTON (57483-185-11) / 150 g in 1 TUBE (57483-185-01)

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": "ad9d2c28-21bc-4f81-9c90-cce6a96d976a", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855633"], "spl_set_id": ["ad9d2c28-21bc-4f81-9c90-cce6a96d976a"], "manufacturer_name": ["INNOVUS PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (57483-185-11)  / 150 g in 1 TUBE (57483-185-01)", "package_ndc": "57483-185-11", "marketing_start_date": "20250325"}], "brand_name": "DICLOFENAC SODIUM", "product_id": "57483-185_ad9d2c28-21bc-4f81-9c90-cce6a96d976a", "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": "57483-185", "generic_name": "DICLOFENAC SODIUM", "labeler_name": "INNOVUS PHARMACEUTICALS, INC.", "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": "20250325", "listing_expiration_date": "20261231"}