diclofenac sodium

Generic: diclofenac sodium

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

diclofenac sodium 75 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-231
Product ID 42291-231_485b95c5-2a91-3aa3-e063-6394a90a10d7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075185
Listing Expiration 2027-12-31
Marketing Start 2011-03-17

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 42291231
Hyphenated Format 42291-231

Supplemental Identifiers

RxCUI
855906 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 ANDA075185 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-231-10)
  • 180 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-231-18)
source: ndc

Packages (2)

42291-231-10 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-231-10) 42291-231-18 180 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-231-18)

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": "485b95c5-2a91-3aa3-e063-6394a90a10d7", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855906", "855926"], "spl_set_id": ["19b4ff5c-adb7-a0d0-7ef2-4ae05047fd94"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-231-10)", "package_ndc": "42291-231-10", "marketing_start_date": "20130516"}, {"sample": false, "description": "180 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-231-18)", "package_ndc": "42291-231-18", "marketing_start_date": "20110317"}], "brand_name": "Diclofenac Sodium", "product_id": "42291-231_485b95c5-2a91-3aa3-e063-6394a90a10d7", "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": "42291-231", "generic_name": "Diclofenac Sodium", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "75 mg/1"}], "application_number": "ANDA075185", "marketing_category": "ANDA", "marketing_start_date": "20110317", "listing_expiration_date": "20271231"}