diclofenac sodium

Generic: diclofenac sodium topical gel, 1%

Labeler: dr. reddy's laboratories inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium topical gel, 1%
Labeler dr. reddy's laboratories inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 10 mg/g

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-885
Product ID 43598-885_0b8a2c28-1b4b-0ace-eff9-255a1c2dab82
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210986
Listing Expiration 2026-12-31
Marketing Start 2020-12-14

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 43598885
Hyphenated Format 43598-885

Supplemental Identifiers

RxCUI
855633
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 topical gel, 1% (source: ndc)
Application Number ANDA210986 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (43598-885-10) / 100 g in 1 TUBE
  • 1 TUBE in 1 CARTON (43598-885-15) / 150 g in 1 TUBE
  • 2 TUBE in 1 CARTON (43598-885-21) / 100 g in 1 TUBE
  • 1 TUBE in 1 CARTON (43598-885-50) / 50 g in 1 TUBE
source: ndc

Packages (4)

43598-885-10 1 TUBE in 1 CARTON (43598-885-10) / 100 g in 1 TUBE 43598-885-15 1 TUBE in 1 CARTON (43598-885-15) / 150 g in 1 TUBE 43598-885-21 2 TUBE in 1 CARTON (43598-885-21) / 100 g in 1 TUBE 43598-885-50 1 TUBE in 1 CARTON (43598-885-50) / 50 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": "0b8a2c28-1b4b-0ace-eff9-255a1c2dab82", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855633"], "spl_set_id": ["c88b2512-0255-658d-252a-c006275159b0"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (43598-885-10)  / 100 g in 1 TUBE", "package_ndc": "43598-885-10", "marketing_start_date": "20201214"}, {"sample": false, "description": "1 TUBE in 1 CARTON (43598-885-15)  / 150 g in 1 TUBE", "package_ndc": "43598-885-15", "marketing_start_date": "20210131"}, {"sample": false, "description": "2 TUBE in 1 CARTON (43598-885-21)  / 100 g in 1 TUBE", "package_ndc": "43598-885-21", "marketing_start_date": "20220115"}, {"sample": false, "description": "1 TUBE in 1 CARTON (43598-885-50)  / 50 g in 1 TUBE", "package_ndc": "43598-885-50", "marketing_start_date": "20210131"}], "brand_name": "DICLOFENAC SODIUM", "product_id": "43598-885_0b8a2c28-1b4b-0ace-eff9-255a1c2dab82", "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": "43598-885", "generic_name": "diclofenac sodium topical gel, 1%", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DICLOFENAC SODIUM", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "10 mg/g"}], "application_number": "ANDA210986", "marketing_category": "ANDA", "marketing_start_date": "20201214", "listing_expiration_date": "20261231"}