diclofenac sodium

Generic: diclofenac sodium

Labeler: equate (wal-mart stores, inc.) (see also wal-mart inc)
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler equate (wal-mart stores, inc.) (see also wal-mart inc)
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 10 mg/g

Manufacturer
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)

Identifiers & Regulatory

Product NDC 49035-269
Product ID 49035-269_6657f28e-6f37-4499-9695-bcded504f1b6
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208077
Listing Expiration 2026-12-31
Marketing Start 2021-05-03

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 49035269
Hyphenated Format 49035-269

Supplemental Identifiers

RxCUI
855633
UPC
0681131357425
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 ANDA208077 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (49035-269-17) / 50 g in 1 TUBE
  • 1 TUBE in 1 CARTON (49035-269-35) / 100 g in 1 TUBE
  • 1 TUBE in 1 CARTON (49035-269-53) / 150 g in 1 TUBE
source: ndc

Packages (3)

49035-269-17 1 TUBE in 1 CARTON (49035-269-17) / 50 g in 1 TUBE 49035-269-35 1 TUBE in 1 CARTON (49035-269-35) / 100 g in 1 TUBE 49035-269-53 1 TUBE in 1 CARTON (49035-269-53) / 150 g in 1 TUBE

Ingredients (1)

diclofenac sodium (10 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": "6657f28e-6f37-4499-9695-bcded504f1b6", "openfda": {"upc": ["0681131357425"], "unii": ["QTG126297Q"], "rxcui": ["855633"], "spl_set_id": ["2a7019e9-e20f-4897-9b8e-942a7f2b34f6"], "manufacturer_name": ["EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (49035-269-17)  / 50 g in 1 TUBE", "package_ndc": "49035-269-17", "marketing_start_date": "20210503"}, {"sample": false, "description": "1 TUBE in 1 CARTON (49035-269-35)  / 100 g in 1 TUBE", "package_ndc": "49035-269-35", "marketing_start_date": "20210503"}, {"sample": false, "description": "1 TUBE in 1 CARTON (49035-269-53)  / 150 g in 1 TUBE", "package_ndc": "49035-269-53", "marketing_start_date": "20210503"}], "brand_name": "Diclofenac sodium", "product_id": "49035-269_6657f28e-6f37-4499-9695-bcded504f1b6", "dosage_form": "GEL", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "49035-269", "generic_name": "Diclofenac sodium", "labeler_name": "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diclofenac sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "10 mg/g"}], "application_number": "ANDA208077", "marketing_category": "ANDA", "marketing_start_date": "20210503", "listing_expiration_date": "20261231"}