diclofenac sodium

Generic: diclofenac sodium

Labeler: quality care products llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler quality care products llc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

diclofenac sodium 16.05 mg/mL

Manufacturer
Quality Care Products LLC

Identifiers & Regulatory

Product NDC 55700-591
Product ID 55700-591_05da3eba-6809-41fc-b02d-a357a57e4b09
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202769
Marketing Start 2018-03-09
Marketing End 2028-10-19

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 55700591
Hyphenated Format 55700-591

Supplemental Identifiers

RxCUI
857700
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 ANDA202769 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 16.05 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (55700-591-15) / 150 mL in 1 BOTTLE
source: ndc

Packages (1)

55700-591-15 1 BOTTLE in 1 CARTON (55700-591-15) / 150 mL in 1 BOTTLE

Ingredients (1)

diclofenac sodium (16.05 mg/mL)

Linked Drug Pages (1)

Diclofenac Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "05da3eba-6809-41fc-b02d-a357a57e4b09", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["857700"], "spl_set_id": ["94422b85-28ed-477f-853a-71d1d6cf17d5"], "manufacturer_name": ["Quality Care Products LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (55700-591-15)  / 150 mL in 1 BOTTLE", "package_ndc": "55700-591-15", "marketing_end_date": "20281019", "marketing_start_date": "20180309"}], "brand_name": "Diclofenac Sodium", "product_id": "55700-591_05da3eba-6809-41fc-b02d-a357a57e4b09", "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": "55700-591", "generic_name": "Diclofenac Sodium", "labeler_name": "Quality Care Products LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "16.05 mg/mL"}], "application_number": "ANDA202769", "marketing_category": "ANDA", "marketing_end_date": "20281019", "marketing_start_date": "20180309"}