diclofenac sodium

Generic: diclofenac sodium topical gel, 1%

Labeler: encube ethicals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium topical gel, 1%
Labeler encube ethicals, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 10 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-044
Product ID 21922-044_fac5ba8a-cf2d-4cba-8a98-55fc36e554ca
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210986
Listing Expiration 2026-12-31
Marketing Start 2020-08-11

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 21922044
Hyphenated Format 21922-044

Supplemental Identifiers

RxCUI
855633
UPC
0321922044263 0321922044256 0321922044140 0321922044096
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 topical gel, 1% (source: ndc)
Application Number ANDA210986 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (21922-044-09) / 100 g in 1 TUBE
  • 1 TUBE in 1 CARTON (21922-044-14) / 50 g in 1 TUBE
  • 1 TUBE in 1 CARTON (21922-044-25) / 20 g in 1 TUBE
  • 1 TUBE in 1 CARTON (21922-044-26) / 150 g in 1 TUBE
source: ndc

Packages (4)

21922-044-09 1 TUBE in 1 CARTON (21922-044-09) / 100 g in 1 TUBE 21922-044-14 1 TUBE in 1 CARTON (21922-044-14) / 50 g in 1 TUBE 21922-044-25 1 TUBE in 1 CARTON (21922-044-25) / 20 g in 1 TUBE 21922-044-26 1 TUBE in 1 CARTON (21922-044-26) / 150 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": "fac5ba8a-cf2d-4cba-8a98-55fc36e554ca", "openfda": {"upc": ["0321922044263", "0321922044256", "0321922044140", "0321922044096"], "unii": ["QTG126297Q"], "rxcui": ["855633"], "spl_set_id": ["6e8c45e1-8cd4-4ff7-a758-f9d2ed37e593"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (21922-044-09)  / 100 g in 1 TUBE", "package_ndc": "21922-044-09", "marketing_start_date": "20200811"}, {"sample": false, "description": "1 TUBE in 1 CARTON (21922-044-14)  / 50 g in 1 TUBE", "package_ndc": "21922-044-14", "marketing_start_date": "20210201"}, {"sample": false, "description": "1 TUBE in 1 CARTON (21922-044-25)  / 20 g in 1 TUBE", "package_ndc": "21922-044-25", "marketing_start_date": "20210201"}, {"sample": false, "description": "1 TUBE in 1 CARTON (21922-044-26)  / 150 g in 1 TUBE", "package_ndc": "21922-044-26", "marketing_start_date": "20210201"}], "brand_name": "DICLOFENAC SODIUM", "product_id": "21922-044_fac5ba8a-cf2d-4cba-8a98-55fc36e554ca", "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": "21922-044", "generic_name": "diclofenac sodium topical gel, 1%", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DICLOFENAC SODIUM", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "10 mg/g"}], "application_number": "ANDA210986", "marketing_category": "ANDA", "marketing_start_date": "20200811", "listing_expiration_date": "20261231"}