diclofenac sodium

Generic: diclofenac sodium

Labeler: nucare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

diclofenac sodium 10 mg/g

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3665
Product ID 68071-3665_200c11a5-d944-b7ba-e063-6394a90a590f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209903
Listing Expiration 2026-12-31
Marketing Start 2018-08-16

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 680713665
Hyphenated Format 68071-3665

Supplemental Identifiers

RxCUI
855633
UPC
0368071366518
UNII
QTG126297Q

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 ANDA209903 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (68071-3665-1) / 100 g in 1 TUBE
source: ndc

Packages (1)

68071-3665-1 1 TUBE in 1 CARTON (68071-3665-1) / 100 g in 1 TUBE

Ingredients (1)

diclofenac sodium (10 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": "200c11a5-d944-b7ba-e063-6394a90a590f", "openfda": {"upc": ["0368071366518"], "unii": ["QTG126297Q"], "rxcui": ["855633"], "spl_set_id": ["200c2800-a703-e138-e063-6394a90acc09"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68071-3665-1)  / 100 g in 1 TUBE", "package_ndc": "68071-3665-1", "marketing_start_date": "20180816"}], "brand_name": "Diclofenac Sodium", "product_id": "68071-3665_200c11a5-d944-b7ba-e063-6394a90a590f", "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": "68071-3665", "generic_name": "Diclofenac Sodium", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "10 mg/g"}], "application_number": "ANDA209903", "marketing_category": "ANDA", "marketing_start_date": "20180816", "listing_expiration_date": "20261231"}