diclofenac sodium

Generic: diclofenac sodium

Labeler: aurolife pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler aurolife pharma llc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

diclofenac sodium 20 mg/g

Manufacturer
Aurolife Pharma LLC

Identifiers & Regulatory

Product NDC 13107-269
Product ID 13107-269_4111df69-8bfb-4082-98a0-c7f6083ea093
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213040
Listing Expiration 2026-12-31
Marketing Start 2023-02-03

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 13107269
Hyphenated Format 13107-269

Supplemental Identifiers

RxCUI
1487074
UPC
0313107269479
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 ANDA213040 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (13107-269-47) / 112 g in 1 BOTTLE
source: ndc

Packages (1)

13107-269-47 1 BOTTLE in 1 CARTON (13107-269-47) / 112 g in 1 BOTTLE

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": "4111df69-8bfb-4082-98a0-c7f6083ea093", "openfda": {"upc": ["0313107269479"], "unii": ["QTG126297Q"], "rxcui": ["1487074"], "spl_set_id": ["dfb7afdf-5c05-4487-9044-936e151e5ba6"], "manufacturer_name": ["Aurolife Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (13107-269-47)  / 112 g in 1 BOTTLE", "package_ndc": "13107-269-47", "marketing_start_date": "20230203"}], "brand_name": "Diclofenac Sodium", "product_id": "13107-269_4111df69-8bfb-4082-98a0-c7f6083ea093", "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": "13107-269", "generic_name": "Diclofenac Sodium", "labeler_name": "Aurolife Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "20 mg/g"}], "application_number": "ANDA213040", "marketing_category": "ANDA", "marketing_start_date": "20230203", "listing_expiration_date": "20261231"}