diclofenac sodium

Generic: diclofenac sodium

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

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler lupin pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

diclofenac sodium 20 mg/g

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-537
Product ID 68180-537_0870b0ce-7ec1-4f5f-9ac8-a3d6de6f663f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208021
Listing Expiration 2026-12-31
Marketing Start 2024-02-19

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 68180537
Hyphenated Format 68180-537

Supplemental Identifiers

RxCUI
1487074
UNII
QTG126297Q

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 sodium (source: ndc)
Generic Name diclofenac sodium (source: ndc)
Application Number ANDA208021 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (68180-537-01) / 112 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

68180-537-01 1 BOTTLE, PUMP in 1 CARTON (68180-537-01) / 112 g in 1 BOTTLE, PUMP

Ingredients (1)

diclofenac sodium (20 mg/g)

Linked Drug Pages (1)

Diclofenac Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0870b0ce-7ec1-4f5f-9ac8-a3d6de6f663f", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["1487074"], "spl_set_id": ["609c5344-9c97-4fa8-ad53-d0f622ce64ec"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (68180-537-01)  / 112 g in 1 BOTTLE, PUMP", "package_ndc": "68180-537-01", "marketing_start_date": "20240219"}], "brand_name": "Diclofenac Sodium", "product_id": "68180-537_0870b0ce-7ec1-4f5f-9ac8-a3d6de6f663f", "dosage_form": "SOLUTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68180-537", "generic_name": "Diclofenac Sodium", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "20 mg/g"}], "application_number": "ANDA208021", "marketing_category": "ANDA", "marketing_start_date": "20240219", "listing_expiration_date": "20261231"}