diclofenac sodium

Generic: diclofenac sodium

Labeler: edenbridge pharmaceuticals llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler edenbridge pharmaceuticals llc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

diclofenac sodium 100 mg/1

Manufacturer
Edenbridge Pharmaceuticals LLC.

Identifiers & Regulatory

Product NDC 42799-953
Product ID 42799-953_50827dab-3a98-4af3-ba36-3afcd814c6e3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076201
Listing Expiration 2027-12-31
Marketing Start 2002-11-06

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 42799953
Hyphenated Format 42799-953

Supplemental Identifiers

RxCUI
855657
UPC
0342799953014
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 ANDA076201 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42799-953-01)
source: ndc

Packages (1)

42799-953-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42799-953-01)

Ingredients (1)

diclofenac sodium (100 mg/1)

Linked Drug Pages (1)

Diclofenac Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "50827dab-3a98-4af3-ba36-3afcd814c6e3", "openfda": {"upc": ["0342799953014"], "unii": ["QTG126297Q"], "rxcui": ["855657"], "spl_set_id": ["bd25a2b1-a4d5-4893-97d1-efdcd414a97d"], "manufacturer_name": ["Edenbridge Pharmaceuticals LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42799-953-01)", "package_ndc": "42799-953-01", "marketing_start_date": "20230614"}], "brand_name": "Diclofenac Sodium", "product_id": "42799-953_50827dab-3a98-4af3-ba36-3afcd814c6e3", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "42799-953", "generic_name": "Diclofenac Sodium", "labeler_name": "Edenbridge Pharmaceuticals LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "100 mg/1"}], "application_number": "ANDA076201", "marketing_category": "ANDA", "marketing_start_date": "20021106", "listing_expiration_date": "20271231"}