diclofenac sodium

Generic: diclofenac sodium 1%

Labeler: asclemed usa, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium 1%
Labeler asclemed usa, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 10 mg/g

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-691
Product ID 76420-691_4850d2cb-f37f-bcae-e063-6294a90aecf7
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210986
Listing Expiration 2027-12-31
Marketing Start 2021-03-17

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 76420691
Hyphenated Format 76420-691

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 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 (76420-691-01) / 100 g in 1 TUBE
source: ndc

Packages (1)

76420-691-01 1 TUBE in 1 CARTON (76420-691-01) / 100 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": "4850d2cb-f37f-bcae-e063-6294a90aecf7", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855633"], "spl_set_id": ["6952a221-17fd-4592-8edc-ff3699743533"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (76420-691-01)  / 100 g in 1 TUBE", "package_ndc": "76420-691-01", "marketing_start_date": "20231219"}], "brand_name": "Diclofenac Sodium", "product_id": "76420-691_4850d2cb-f37f-bcae-e063-6294a90aecf7", "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": "76420-691", "generic_name": "Diclofenac Sodium 1%", "labeler_name": "Asclemed USA, 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": "20210317", "listing_expiration_date": "20271231"}