diclofenac sodium

Generic: diclofenac sodium

Labeler: phoenix rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler phoenix rx llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

diclofenac sodium 75 mg/1

Manufacturer
PHOENIX RX LLC

Identifiers & Regulatory

Product NDC 85509-1201
Product ID 85509-1201_47ce6fbc-b69b-f4de-e063-6294a90ae435
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077863
Listing Expiration 2027-12-31
Marketing Start 2008-08-19

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 855091201
Hyphenated Format 85509-1201

Supplemental Identifiers

RxCUI
855926
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 ANDA077863 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1201-3)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (85509-1201-6)
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1201-9)
source: ndc

Packages (3)

85509-1201-3 30 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1201-3) 85509-1201-6 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (85509-1201-6) 85509-1201-9 90 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1201-9)

Ingredients (1)

diclofenac sodium (75 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": "47ce6fbc-b69b-f4de-e063-6294a90ae435", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855926"], "spl_set_id": ["47ce6fab-be1d-0076-e063-6294a90add63"], "manufacturer_name": ["PHOENIX RX LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1201-3)", "package_ndc": "85509-1201-3", "marketing_start_date": "20260107"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (85509-1201-6)", "package_ndc": "85509-1201-6", "marketing_start_date": "20260107"}, {"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1201-9)", "package_ndc": "85509-1201-9", "marketing_start_date": "20260107"}], "brand_name": "Diclofenac Sodium", "product_id": "85509-1201_47ce6fbc-b69b-f4de-e063-6294a90ae435", "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": "85509-1201", "generic_name": "Diclofenac Sodium", "labeler_name": "PHOENIX RX LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "75 mg/1"}], "application_number": "ANDA077863", "marketing_category": "ANDA", "marketing_start_date": "20080819", "listing_expiration_date": "20271231"}