diclofenac sodium

Generic: diclofenac sodium

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

diclofenac sodium 50 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0228-2550
Product ID 0228-2550_138c73c2-488a-440d-9a47-7a2a56920f2b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074514
Listing Expiration 2026-12-31
Marketing Start 1996-03-26

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 02282550
Hyphenated Format 0228-2550

Supplemental Identifiers

RxCUI
855906 855926
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 ANDA074514 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2550-06)
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2550-11)
  • 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2550-96)
source: ndc

Packages (3)

0228-2550-06 60 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2550-06) 0228-2550-11 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2550-11) 0228-2550-96 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2550-96)

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": "138c73c2-488a-440d-9a47-7a2a56920f2b", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855906", "855926"], "spl_set_id": ["a57b897e-0cbe-4ac3-969f-b00357a0cfa8"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2550-06)", "package_ndc": "0228-2550-06", "marketing_start_date": "19960326"}, {"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2550-11)", "package_ndc": "0228-2550-11", "marketing_start_date": "19960326"}, {"sample": false, "description": "1000 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2550-96)", "package_ndc": "0228-2550-96", "marketing_start_date": "19960326"}], "brand_name": "Diclofenac Sodium", "product_id": "0228-2550_138c73c2-488a-440d-9a47-7a2a56920f2b", "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": "0228-2550", "generic_name": "Diclofenac Sodium", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "50 mg/1"}], "application_number": "ANDA074514", "marketing_category": "ANDA", "marketing_start_date": "19960326", "listing_expiration_date": "20261231"}