diclofenac sodium (43386-016)

Drug Facts

Product Profile

Brand Name diclofenac sodium

Generic Name diclofenac sodium

Labeler lupin pharmaceuticals,inc.

Dosage Form SOLUTION

Routes

TOPICAL

Active Ingredients

diclofenac sodium 16.05 mg/mL

Manufacturer

Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-016

Product ID 43386-016_9d8e578d-3a5b-4d9d-bdac-618067779f81

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA205878

Listing Expiration 2026-12-31

Marketing Start 2015-12-09

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 43386016

Hyphenated Format 43386-016

Supplemental Identifiers

RxCUI

857700

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 ANDA205878 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

16.05 mg/mL

source: ndc

Packaging

16 HOW SUPPLIED/STORAGE AND HANDLING Diclofenac sodium topical solution 1.5% w/w. is supplied as a clear, colorless to faintly pink-orange solution containing 16.05 mg of diclofenac sodium per mL of solution, in a white high density polyethylene bottle with a white low-density dropper cap. NDC Number & Size 150 mL bottle NDC # 43386-016-61 Storage Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label – 150 mL Carton Label 489c204a-figure-05 Carton Label

source: label

Packages (0)

No package records.

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": "9d8e578d-3a5b-4d9d-bdac-618067779f81", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["857700"], "spl_set_id": ["7559928e-eeb8-47e8-8a55-d59e06bbc737"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "DICLOFENAC SODIUM", "product_id": "43386-016_9d8e578d-3a5b-4d9d-bdac-618067779f81", "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": "43386-016", "generic_name": "DICLOFENAC SODIUM", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DICLOFENAC SODIUM", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "16.05 mg/mL"}], "application_number": "ANDA205878", "marketing_category": "ANDA", "marketing_start_date": "20151209", "listing_expiration_date": "20261231"}