diclofenac sodium

Generic: diclofenac sodium

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

Drug Facts

Product Profile

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

diclofenac sodium 30 mg/g

Manufacturer
GLENMARK PHARMACEUTICALS INC., USA

Identifiers & Regulatory

Product NDC 68462-355
Product ID 68462-355_6c2982e4-c4a4-4985-82d1-e418c5e055e1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208301
Listing Expiration 2026-12-31
Marketing Start 2016-09-13

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 68462355
Hyphenated Format 68462-355

Supplemental Identifiers

RxCUI
855642
UPC
0368462355947
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 ANDA208301 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (68462-355-94) / 100 g in 1 TUBE
source: ndc

Packages (1)

68462-355-94 1 TUBE in 1 CARTON (68462-355-94) / 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": "6c2982e4-c4a4-4985-82d1-e418c5e055e1", "openfda": {"upc": ["0368462355947"], "unii": ["QTG126297Q"], "rxcui": ["855642"], "spl_set_id": ["dab3ae60-0135-43b3-a1d0-8752720af82a"], "manufacturer_name": ["GLENMARK PHARMACEUTICALS INC., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68462-355-94)  / 100 g in 1 TUBE", "package_ndc": "68462-355-94", "marketing_start_date": "20160913"}], "brand_name": "DICLOFENAC SODIUM", "product_id": "68462-355_6c2982e4-c4a4-4985-82d1-e418c5e055e1", "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": "68462-355", "generic_name": "diclofenac sodium", "labeler_name": "GLENMARK PHARMACEUTICALS INC., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DICLOFENAC SODIUM", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "30 mg/g"}], "application_number": "ANDA208301", "marketing_category": "ANDA", "marketing_start_date": "20160913", "listing_expiration_date": "20261231"}