diclofenac sodium

Generic: diclofenac sodium

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler sun pharmaceutical industries, inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

diclofenac sodium 16.05 mg/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1358
Product ID 51672-1358_4b20d36c-e921-489d-e063-6294a90ad63b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203818
Listing Expiration 2027-12-31
Marketing Start 2014-11-26

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 516721358
Hyphenated Format 51672-1358

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 ANDA203818 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 16.05 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (51672-1358-2) / 150 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

51672-1358-2 1 BOTTLE, DROPPER in 1 CARTON (51672-1358-2) / 150 mL in 1 BOTTLE, DROPPER

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": "4b20d36c-e921-489d-e063-6294a90ad63b", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["857700"], "spl_set_id": ["fae53d24-acf1-4250-888d-b8d965ffc3d3"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (51672-1358-2)  / 150 mL in 1 BOTTLE, DROPPER", "package_ndc": "51672-1358-2", "marketing_start_date": "20141126"}], "brand_name": "Diclofenac Sodium", "product_id": "51672-1358_4b20d36c-e921-489d-e063-6294a90ad63b", "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": "51672-1358", "generic_name": "Diclofenac Sodium", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "16.05 mg/mL"}], "application_number": "ANDA203818", "marketing_category": "ANDA", "marketing_start_date": "20141126", "listing_expiration_date": "20271231"}