diclofenac sodium

Generic: diclofenac sodium

Labeler: rugby laboratories
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler rugby laboratories
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 10 mg/g

Manufacturer
Rugby Laboratories

Identifiers & Regulatory

Product NDC 0536-1294
Product ID 0536-1294_8b734e52-fc53-489b-97a3-bea23f008d40
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208077
Listing Expiration 2027-12-31
Marketing Start 2020-09-14

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 05361294
Hyphenated Format 0536-1294

Supplemental Identifiers

RxCUI
855633
UPC
0305361294977
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 ANDA208077 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0536-1294-31) / 150 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0536-1294-34) / 50 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0536-1294-97) / 100 g in 1 TUBE
source: ndc

Packages (3)

0536-1294-31 1 TUBE in 1 CARTON (0536-1294-31) / 150 g in 1 TUBE 0536-1294-34 1 TUBE in 1 CARTON (0536-1294-34) / 50 g in 1 TUBE 0536-1294-97 1 TUBE in 1 CARTON (0536-1294-97) / 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": "8b734e52-fc53-489b-97a3-bea23f008d40", "openfda": {"upc": ["0305361294977"], "unii": ["QTG126297Q"], "rxcui": ["855633"], "spl_set_id": ["95f3c70c-eded-4d24-b9b0-cfa0b7902d6e"], "manufacturer_name": ["Rugby Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0536-1294-31)  / 150 g in 1 TUBE", "package_ndc": "0536-1294-31", "marketing_end_date": "20271028", "marketing_start_date": "20200914"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0536-1294-34)  / 50 g in 1 TUBE", "package_ndc": "0536-1294-34", "marketing_start_date": "20200914"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0536-1294-97)  / 100 g in 1 TUBE", "package_ndc": "0536-1294-97", "marketing_start_date": "20200914"}], "brand_name": "Diclofenac sodium", "product_id": "0536-1294_8b734e52-fc53-489b-97a3-bea23f008d40", "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": "0536-1294", "generic_name": "Diclofenac sodium", "labeler_name": "Rugby Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diclofenac sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "10 mg/g"}], "application_number": "ANDA208077", "marketing_category": "ANDA", "marketing_start_date": "20200914", "listing_expiration_date": "20271231"}