diclofenac sodium

Generic: diclofenac sodium

Labeler: asclemed usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

diclofenac sodium 75 mg/1

Manufacturer
ASCLEMED USA INC.

Identifiers & Regulatory

Product NDC 76420-393
Product ID 76420-393_3f8fd236-e3e6-30f8-e063-6394a90a4c96
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077863
Listing Expiration 2026-12-31
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 76420393
Hyphenated Format 76420-393

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
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-393-01)
  • 14 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-393-14)
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-393-30)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (76420-393-60)
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-393-90)
source: ndc

Packages (5)

76420-393-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-393-01) 76420-393-14 14 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-393-14) 76420-393-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-393-30) 76420-393-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (76420-393-60) 76420-393-90 90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-393-90)

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": "3f8fd236-e3e6-30f8-e063-6394a90a4c96", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855926"], "spl_set_id": ["48cccc51-feee-43ce-80be-9bea9187b0a2"], "manufacturer_name": ["ASCLEMED USA INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-393-01)", "package_ndc": "76420-393-01", "marketing_start_date": "20250618"}, {"sample": false, "description": "14 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-393-14)", "package_ndc": "76420-393-14", "marketing_start_date": "20250924"}, {"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-393-30)", "package_ndc": "76420-393-30", "marketing_start_date": "20250618"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (76420-393-60)", "package_ndc": "76420-393-60", "marketing_start_date": "20250618"}, {"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-393-90)", "package_ndc": "76420-393-90", "marketing_start_date": "20250618"}], "brand_name": "Diclofenac Sodium", "product_id": "76420-393_3f8fd236-e3e6-30f8-e063-6394a90a4c96", "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": "76420-393", "generic_name": "Diclofenac Sodium", "labeler_name": "ASCLEMED USA INC.", "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": "20261231"}