diclofenac sodium

Generic: diclofenac

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac
Labeler amneal pharmaceuticals llc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

diclofenac sodium 20 mg/g

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-683
Product ID 65162-683_1affc043-5b84-4b94-97be-90f3bd954f34
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208198
Listing Expiration 2026-12-31
Marketing Start 2022-08-23

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 65162683
Hyphenated Format 65162-683

Supplemental Identifiers

RxCUI
1487074
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 (source: ndc)
Application Number ANDA208198 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (65162-683-12) / 112 g in 1 BOTTLE
source: ndc

Packages (1)

65162-683-12 1 BOTTLE in 1 CARTON (65162-683-12) / 112 g in 1 BOTTLE

Ingredients (1)

diclofenac sodium (20 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": "1affc043-5b84-4b94-97be-90f3bd954f34", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["1487074"], "spl_set_id": ["45321aec-368d-4ca4-a0c5-2ce56fae74b2"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65162-683-12)  / 112 g in 1 BOTTLE", "package_ndc": "65162-683-12", "marketing_start_date": "20220823"}], "brand_name": "Diclofenac Sodium", "product_id": "65162-683_1affc043-5b84-4b94-97be-90f3bd954f34", "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": "65162-683", "generic_name": "Diclofenac", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "20 mg/g"}], "application_number": "ANDA208198", "marketing_category": "ANDA", "marketing_start_date": "20220823", "listing_expiration_date": "20261231"}