diclofenac sodium

Generic: diclofenac sodium

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

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler amneal pharmaceuticals of new york llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 30 mg/g

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-1483
Product ID 0115-1483_5104bb6d-35c6-4106-90dc-f70b98025d2b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200936
Listing Expiration 2026-12-31
Marketing Start 2013-11-21

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 01151483
Hyphenated Format 0115-1483

Supplemental Identifiers

RxCUI
855642
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 ANDA200936 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0115-1483-56) / 50 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0115-1483-61) / 100 g in 1 TUBE
source: ndc

Packages (2)

0115-1483-56 1 TUBE in 1 CARTON (0115-1483-56) / 50 g in 1 TUBE 0115-1483-61 1 TUBE in 1 CARTON (0115-1483-61) / 100 g in 1 TUBE

Ingredients (1)

diclofenac sodium (30 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": "5104bb6d-35c6-4106-90dc-f70b98025d2b", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855642"], "spl_set_id": ["8aadab37-9068-45a8-ac9a-8ad87d163b68"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0115-1483-56)  / 50 g in 1 TUBE", "package_ndc": "0115-1483-56", "marketing_start_date": "20131121"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0115-1483-61)  / 100 g in 1 TUBE", "package_ndc": "0115-1483-61", "marketing_start_date": "20131121"}], "brand_name": "Diclofenac Sodium", "product_id": "0115-1483_5104bb6d-35c6-4106-90dc-f70b98025d2b", "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": "0115-1483", "generic_name": "Diclofenac Sodium", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "30 mg/g"}], "application_number": "ANDA200936", "marketing_category": "ANDA", "marketing_start_date": "20131121", "listing_expiration_date": "20261231"}