diclofenac sodium er

Generic: diclofenac sodium

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium er
Generic Name diclofenac sodium
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

diclofenac sodium 100 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0210
Product ID 80425-0210_2a99b834-0c9e-6f97-e063-6394a90a8407
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075492
Listing Expiration 2026-12-31
Marketing Start 2022-11-04

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 804250210
Hyphenated Format 80425-0210

Supplemental Identifiers

RxCUI
855657
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 er (source: ndc)
Generic Name diclofenac sodium (source: ndc)
Application Number ANDA075492 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (80425-0210-1)
source: ndc

Packages (1)

80425-0210-1 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (80425-0210-1)

Ingredients (1)

diclofenac sodium (100 mg/1)

Linked Drug Pages (1)

Diclofenac Sodium ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a99b834-0c9e-6f97-e063-6394a90a8407", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855657"], "spl_set_id": ["ecaa39b8-067c-80d7-e053-2a95a90a7354"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (80425-0210-1)", "package_ndc": "80425-0210-1", "marketing_start_date": "20231104"}], "brand_name": "Diclofenac Sodium ER", "product_id": "80425-0210_2a99b834-0c9e-6f97-e063-6394a90a8407", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "80425-0210", "generic_name": "Diclofenac Sodium", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "brand_name_suffix": "ER", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "100 mg/1"}], "application_number": "ANDA075492", "marketing_category": "ANDA", "marketing_start_date": "20221104", "listing_expiration_date": "20261231"}