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 20 mg/g

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 83008-019
Product ID 83008-019_43a5d516-ca87-46fb-9313-30c48d174a49
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212506
Marketing Start 2023-05-02
Marketing End 2027-05-31

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 83008019
Hyphenated Format 83008-019

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 CARTON (83008-019-12) / 112 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

83008-019-12 1 BOTTLE, PUMP in 1 CARTON (83008-019-12) / 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": "43a5d516-ca87-46fb-9313-30c48d174a49", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["1487074"], "spl_set_id": ["3ee4c4e1-f23b-4d4a-bac7-59546d3a2c8b"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (83008-019-12)  / 112 g in 1 BOTTLE, PUMP", "package_ndc": "83008-019-12", "marketing_end_date": "20270531", "marketing_start_date": "20230502"}], "brand_name": "Diclofenac sodium", "product_id": "83008-019_43a5d516-ca87-46fb-9313-30c48d174a49", "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": "83008-019", "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": "20 mg/g"}], "application_number": "ANDA212506", "marketing_category": "ANDA", "marketing_end_date": "20270531", "marketing_start_date": "20230502"}