diclofenac sodium

Generic: diclofenac sodium

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

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

diclofenac sodium 50 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8784
Product ID 68788-8784_d4e5f932-8371-496b-b551-c70a9ca76bda
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090066
Listing Expiration 2027-12-31
Marketing Start 2024-12-12

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 687888784
Hyphenated Format 68788-8784

Supplemental Identifiers

RxCUI
855906
UNII
QTG126297Q

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 ANDA090066 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-1)
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-3)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-6)
  • 120 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-8)
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-9)
source: ndc

Packages (5)

68788-8784-1 100 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-1) 68788-8784-3 30 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-3) 68788-8784-6 60 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-6) 68788-8784-8 120 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-8) 68788-8784-9 90 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-9)

Ingredients (1)

diclofenac sodium (50 mg/1)

Linked Drug Pages (1)

Diclofenac Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d4e5f932-8371-496b-b551-c70a9ca76bda", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855906"], "spl_set_id": ["4ee64a93-9965-47c8-be2c-14232df44b2b"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-1)", "package_ndc": "68788-8784-1", "marketing_start_date": "20241212"}, {"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-3)", "package_ndc": "68788-8784-3", "marketing_start_date": "20241212"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-6)", "package_ndc": "68788-8784-6", "marketing_start_date": "20241212"}, {"sample": false, "description": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-8)", "package_ndc": "68788-8784-8", "marketing_start_date": "20241212"}, {"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-9)", "package_ndc": "68788-8784-9", "marketing_start_date": "20241212"}], "brand_name": "Diclofenac Sodium", "product_id": "68788-8784_d4e5f932-8371-496b-b551-c70a9ca76bda", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68788-8784", "generic_name": "Diclofenac Sodium", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "50 mg/1"}], "application_number": "ANDA090066", "marketing_category": "ANDA", "marketing_start_date": "20241212", "listing_expiration_date": "20271231"}