diclofenac sodium

Generic: diclofenac sodium

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

diclofenac sodium 30 mg/g

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0472-1783
Product ID 0472-1783_6b4784a2-31ca-485a-9bff-6c322c0cb902
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206493
Marketing Start 2016-05-19
Marketing End 2027-02-28

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 04721783
Hyphenated Format 0472-1783

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 ANDA206493 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0472-1783-10) / 100 g in 1 TUBE
source: ndc

Packages (1)

0472-1783-10 1 TUBE in 1 CARTON (0472-1783-10) / 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": "6b4784a2-31ca-485a-9bff-6c322c0cb902", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855642"], "spl_set_id": ["74169b2d-ac56-4757-86c4-cdcfcd5f4eb5"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0472-1783-10)  / 100 g in 1 TUBE", "package_ndc": "0472-1783-10", "marketing_end_date": "20270228", "marketing_start_date": "20160519"}], "brand_name": "Diclofenac Sodium", "product_id": "0472-1783_6b4784a2-31ca-485a-9bff-6c322c0cb902", "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": "0472-1783", "generic_name": "Diclofenac Sodium", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "30 mg/g"}], "application_number": "ANDA206493", "marketing_category": "ANDA", "marketing_end_date": "20270228", "marketing_start_date": "20160519"}