diclofenac potassium

Generic: diclofenac potassium, film coated

Labeler: havix group inc d-b-a aavis pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac potassium
Generic Name diclofenac potassium, film coated
Labeler havix group inc d-b-a aavis pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diclofenac potassium 50 mg/1

Manufacturer
Havix Group Inc d-b-a Aavis Pharmaceuticals

Identifiers & Regulatory

Product NDC 71337-046
Product ID 71337-046_2a1e049f-58f9-40e8-b7a6-bcd19ef51f75
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215787
Listing Expiration 2026-12-31
Marketing Start 2023-06-25

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 71337046
Hyphenated Format 71337-046

Supplemental Identifiers

RxCUI
855942
UPC
0371337046017
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, film coated (source: ndc)
Application Number ANDA215787 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (71337-046-01)
  • 500 TABLET in 1 BOTTLE (71337-046-05)
source: ndc

Packages (2)

71337-046-01 100 TABLET in 1 BOTTLE (71337-046-01) 71337-046-05 500 TABLET in 1 BOTTLE (71337-046-05)

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": "2a1e049f-58f9-40e8-b7a6-bcd19ef51f75", "openfda": {"upc": ["0371337046017"], "unii": ["L4D5UA6CB4"], "rxcui": ["855942"], "spl_set_id": ["30ab7b30-cc90-4b84-8caf-21058f1d37fa"], "manufacturer_name": ["Havix Group Inc d-b-a Aavis Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (71337-046-01)", "package_ndc": "71337-046-01", "marketing_start_date": "20230626"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (71337-046-05)", "package_ndc": "71337-046-05", "marketing_start_date": "20230626"}], "brand_name": "DICLOFENAC POTASSIUM", "product_id": "71337-046_2a1e049f-58f9-40e8-b7a6-bcd19ef51f75", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "71337-046", "generic_name": "diclofenac potassium, film coated", "labeler_name": "Havix Group Inc d-b-a Aavis Pharmaceuticals", "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": "20230625", "listing_expiration_date": "20261231"}