diclofenac potassium

Generic: diclofenac potassium

Labeler: nivagen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac potassium
Generic Name diclofenac potassium
Labeler nivagen pharmaceuticals, inc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

diclofenac potassium 50 mg/1

Manufacturer
Nivagen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 75834-338
Product ID 75834-338_46982e49-ee38-ad56-e063-6394a90a2816
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217010
Listing Expiration 2026-12-31
Marketing Start 2025-12-15

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 75834338
Hyphenated Format 75834-338

Supplemental Identifiers

RxCUI
859063
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 ANDA217010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 1 POWDER, FOR SOLUTION in 1 PACKET (75834-338-01)
  • 9 POWDER, FOR SOLUTION in 1 CARTON (75834-338-02)
source: ndc

Packages (2)

75834-338-01 1 POWDER, FOR SOLUTION in 1 PACKET (75834-338-01) 75834-338-02 9 POWDER, FOR SOLUTION in 1 CARTON (75834-338-02)

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": "46982e49-ee38-ad56-e063-6394a90a2816", "openfda": {"unii": ["L4D5UA6CB4"], "rxcui": ["859063"], "spl_set_id": ["eb52a015-23cd-40f6-bf83-6749fc34947c"], "manufacturer_name": ["Nivagen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POWDER, FOR SOLUTION in 1 PACKET (75834-338-01)", "package_ndc": "75834-338-01", "marketing_start_date": "20251215"}, {"sample": false, "description": "9 POWDER, FOR SOLUTION in 1 CARTON (75834-338-02)", "package_ndc": "75834-338-02", "marketing_start_date": "20251215"}], "brand_name": "DICLOFENAC POTASSIUM", "product_id": "75834-338_46982e49-ee38-ad56-e063-6394a90a2816", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "75834-338", "generic_name": "Diclofenac potassium", "labeler_name": "Nivagen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DICLOFENAC POTASSIUM", "active_ingredients": [{"name": "DICLOFENAC POTASSIUM", "strength": "50 mg/1"}], "application_number": "ANDA217010", "marketing_category": "ANDA", "marketing_start_date": "20251215", "listing_expiration_date": "20261231"}