diclofenac potassium

Generic: diclofenac potassium

Labeler: sola pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac potassium
Generic Name diclofenac potassium
Labeler sola pharmaceuticals, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diclofenac potassium 50 mg/1

Manufacturer
SOLA Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70512-750
Product ID 70512-750_47d44b29-dfd3-eace-e063-6394a90a4d24
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215787
Listing Expiration 2027-12-31
Marketing Start 2024-10-21

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 70512750
Hyphenated Format 70512-750

Supplemental Identifiers

RxCUI
855942
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 diclofenac potassium (source: ndc)
Generic Name diclofenac potassium (source: ndc)
Application Number ANDA215787 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70512-750-10)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70512-750-50)
source: ndc

Packages (2)

70512-750-10 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70512-750-10) 70512-750-50 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70512-750-50)

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": "47d44b29-dfd3-eace-e063-6394a90a4d24", "openfda": {"unii": ["L4D5UA6CB4"], "rxcui": ["855942"], "spl_set_id": ["e770efc8-bbad-4103-98e4-e31019a540f5"], "manufacturer_name": ["SOLA Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70512-750-10)", "package_ndc": "70512-750-10", "marketing_start_date": "20241021"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70512-750-50)", "package_ndc": "70512-750-50", "marketing_start_date": "20241231"}], "brand_name": "Diclofenac Potassium", "product_id": "70512-750_47d44b29-dfd3-eace-e063-6394a90a4d24", "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": "70512-750", "generic_name": "diclofenac potassium", "labeler_name": "SOLA Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Potassium", "active_ingredients": [{"name": "DICLOFENAC POTASSIUM", "strength": "50 mg/1"}], "application_number": "ANDA215787", "marketing_category": "ANDA", "marketing_start_date": "20241021", "listing_expiration_date": "20271231"}