diclofenac sodium

Generic: diclofenac sodium

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

Drug Facts

Product Profile

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

diclofenac sodium 75 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-201
Product ID 16571-201_504b1904-033c-4fd8-92c9-41e31154f808
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 16571201
Hyphenated Format 16571-201

Supplemental Identifiers

RxCUI
855664 855906 855926
UPC
0316571202102
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 ANDA077863 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (16571-201-06)
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-201-10)
  • 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-201-11)
  • 500 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-201-50)
source: ndc

Packages (4)

16571-201-06 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (16571-201-06) 16571-201-10 100 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-201-10) 16571-201-11 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-201-11) 16571-201-50 500 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-201-50)

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": "504b1904-033c-4fd8-92c9-41e31154f808", "openfda": {"upc": ["0316571202102"], "unii": ["QTG126297Q"], "rxcui": ["855664", "855906", "855926"], "spl_set_id": ["3330ea92-fc9d-4541-b378-be399b0995d3"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (16571-201-06)", "package_ndc": "16571-201-06", "marketing_start_date": "20080819"}, {"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-201-10)", "package_ndc": "16571-201-10", "marketing_start_date": "20080819"}, {"sample": false, "description": "1000 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-201-11)", "package_ndc": "16571-201-11", "marketing_start_date": "20080819"}, {"sample": false, "description": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-201-50)", "package_ndc": "16571-201-50", "marketing_start_date": "20080819"}], "brand_name": "Diclofenac Sodium", "product_id": "16571-201_504b1904-033c-4fd8-92c9-41e31154f808", "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": "16571-201", "generic_name": "Diclofenac Sodium", "labeler_name": "Rising Pharma Holdings, 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"}