diclofenac sodium

Generic: diclofenac sodium

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler nucare pharmaceuticals,inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 30 mg/g

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3516
Product ID 68071-3516_4af5a0b8-d72d-cca7-e063-6294a90a1b7f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208301
Listing Expiration 2027-12-31
Marketing Start 2016-09-13

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 680713516
Hyphenated Format 68071-3516

Supplemental Identifiers

RxCUI
855642
UPC
0368071351613
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 ANDA208301 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (68071-3516-1) / 100 g in 1 TUBE
source: ndc

Packages (1)

68071-3516-1 1 TUBE in 1 CARTON (68071-3516-1) / 100 g in 1 TUBE

Ingredients (1)

diclofenac sodium (30 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": "4af5a0b8-d72d-cca7-e063-6294a90a1b7f", "openfda": {"upc": ["0368071351613"], "unii": ["QTG126297Q"], "rxcui": ["855642"], "spl_set_id": ["06862cf2-9537-6661-e063-6294a90a2084"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68071-3516-1)  / 100 g in 1 TUBE", "package_ndc": "68071-3516-1", "marketing_start_date": "20230929"}], "brand_name": "DICLOFENAC SODIUM", "product_id": "68071-3516_4af5a0b8-d72d-cca7-e063-6294a90a1b7f", "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": "68071-3516", "generic_name": "diclofenac sodium", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DICLOFENAC SODIUM", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "30 mg/g"}], "application_number": "ANDA208301", "marketing_category": "ANDA", "marketing_start_date": "20160913", "listing_expiration_date": "20271231"}