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 SOLUTION
Routes
TOPICAL
Active Ingredients

diclofenac sodium 20 mg/g

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-055
Product ID 42291-055_484c1f52-6419-1ce3-e063-6394a90aa297
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212506
Listing Expiration 2027-12-31
Marketing Start 2023-08-29

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 42291055
Hyphenated Format 42291-055

Supplemental Identifiers

RxCUI
1487074
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 ANDA212506 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 BOX (42291-055-12) / 112 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

42291-055-12 1 BOTTLE, PUMP in 1 BOX (42291-055-12) / 112 g in 1 BOTTLE, PUMP

Ingredients (1)

diclofenac sodium (20 mg/g)

Linked Drug Pages (1)

Diclofenac sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "484c1f52-6419-1ce3-e063-6394a90aa297", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["1487074"], "spl_set_id": ["0416ce03-c345-9d9e-e063-6294a90ad940"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 BOX (42291-055-12)  / 112 g in 1 BOTTLE, PUMP", "package_ndc": "42291-055-12", "marketing_start_date": "20230829"}], "brand_name": "Diclofenac sodium", "product_id": "42291-055_484c1f52-6419-1ce3-e063-6394a90aa297", "dosage_form": "SOLUTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "42291-055", "generic_name": "Diclofenac sodium", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "20 mg/g"}], "application_number": "ANDA212506", "marketing_category": "ANDA", "marketing_start_date": "20230829", "listing_expiration_date": "20271231"}