diclofenac potassium

Generic: diclofenac potassium

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac potassium
Generic Name diclofenac potassium
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diclofenac potassium 50 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3538
Product ID 70518-3538_4717b1e9-57af-22bb-e063-6294a90a1cc3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215585
Listing Expiration 2026-12-31
Marketing Start 2022-09-26

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 705183538
Hyphenated Format 70518-3538

Supplemental Identifiers

RxCUI
855942
UNII
L4D5UA6CB4

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 potassium (source: ndc)
Generic Name diclofenac potassium (source: ndc)
Application Number ANDA215585 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3538-1)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3538-3)
source: ndc

Packages (2)

70518-3538-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3538-1) 70518-3538-3 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3538-3)

Ingredients (1)

diclofenac potassium (50 mg/1)

Linked Drug Pages (1)

Diclofenac Potassium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4717b1e9-57af-22bb-e063-6294a90a1cc3", "openfda": {"unii": ["L4D5UA6CB4"], "rxcui": ["855942"], "spl_set_id": ["c4976d69-ca06-4263-9240-6fd8b44a9b6d"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3538-1)", "package_ndc": "70518-3538-1", "marketing_start_date": "20221219"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3538-3)", "package_ndc": "70518-3538-3", "marketing_start_date": "20230406"}], "brand_name": "Diclofenac Potassium", "product_id": "70518-3538_4717b1e9-57af-22bb-e063-6294a90a1cc3", "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": "70518-3538", "generic_name": "diclofenac potassium", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Potassium", "active_ingredients": [{"name": "DICLOFENAC POTASSIUM", "strength": "50 mg/1"}], "application_number": "ANDA215585", "marketing_category": "ANDA", "marketing_start_date": "20220926", "listing_expiration_date": "20261231"}