lofena

Generic: diclofenac potassium

Labeler: carwin pharmaceutical associates, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lofena
Generic Name diclofenac potassium
Labeler carwin pharmaceutical associates, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diclofenac potassium 25 mg/1

Manufacturer
Carwin Pharmaceutical Associates, LLC

Identifiers & Regulatory

Product NDC 15370-180
Product ID 15370-180_2a1bac02-dabb-4afe-a378-bc4451dcb0cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076561
Listing Expiration 2026-12-31
Marketing Start 2021-10-25

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 15370180
Hyphenated Format 15370-180

Supplemental Identifiers

RxCUI
857702 2584350
UPC
0315370180604
UNII
L4D5UA6CB4

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 lofena (source: ndc)
Generic Name diclofenac potassium (source: ndc)
Application Number ANDA076561 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (15370-180-10)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15370-180-60)
source: ndc

Packages (2)

15370-180-10 1000 TABLET, FILM COATED in 1 BOTTLE (15370-180-10) 15370-180-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15370-180-60)

Ingredients (1)

diclofenac potassium (25 mg/1)

Linked Drug Pages (1)

LOFENA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a1bac02-dabb-4afe-a378-bc4451dcb0cc", "openfda": {"upc": ["0315370180604"], "unii": ["L4D5UA6CB4"], "rxcui": ["857702", "2584350"], "spl_set_id": ["49bd64cc-5edb-44f2-8e24-1249f6a76663"], "manufacturer_name": ["Carwin Pharmaceutical Associates, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (15370-180-10)", "package_ndc": "15370-180-10", "marketing_start_date": "20211025"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15370-180-60)", "package_ndc": "15370-180-60", "marketing_start_date": "20211025"}], "brand_name": "LOFENA", "product_id": "15370-180_2a1bac02-dabb-4afe-a378-bc4451dcb0cc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "15370-180", "generic_name": "DICLOFENAC POTASSIUM", "labeler_name": "Carwin Pharmaceutical Associates, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LOFENA", "active_ingredients": [{"name": "DICLOFENAC POTASSIUM", "strength": "25 mg/1"}], "application_number": "ANDA076561", "marketing_category": "ANDA", "marketing_start_date": "20211025", "listing_expiration_date": "20261231"}