Home › NDC Lookup › Ingredients › Diclofenac Sodium › 80425-0234-01
🧴image loading
(from DailyMed)

Diclofenac Sodium 30 mg/g Gel — NDC 80425-0234-1 (Billing 80425-0234-01)

by Advanced Rx Pharmacy of Tennessee, LLC · 1 TUBE in 1 CARTON / 100 g in 1 TUBE

This is a package of Diclofenac Sodium 30 mg/g Gel from Advanced Rx Pharmacy of Tennessee, LLC, marketed since Jan 2023 and currently FDA-listed. It is this product's only package size.

NDC 80425-0234-01
🏷️ FDA NDC (as labeled) 80425-0234-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Diclofenac Sodium (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jan 27, 2026 — Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0342-2026
Class III · Dec 22, 2025 — Failed PH Specifications (Cipla USA, Inc.) · FDA recall D-0291-2026
Class II · Jun 22, 2023 — Defective Delivery System (ALEMBIC PHARMACEUTICALS, INC.) · FDA recall D-0941-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 80425-0234-1
Product NDC 80425-0234
11-digit billing NDC 80425023401
NCPDP billing unit GM — per gram (weight)
RxCUI 855642
UNII QTG126297Q
Application # ANDA200936
SPL Set ID f187ae44-71be-a682-e053-2995a90a6426
Established class (EPC) Anti-Inflammatory Agents; Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Physiologic effect Decreased Prostaglandin Production
Chemical class Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-01-09
Route TOPICAL
Dosage form GEL
Substance DICLOFENAC SODIUM
Quick answers
  • RxCUI (RxNorm): 855642
Why two NDCs? The FDA registers this code as 80425-0234-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 80425-0234-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other dermatologicals, Acetic acid derivatives and related substances, Antiinflammatory preparations, non-steroids for topical use
How it works Cyclooxygenase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It's an NSAID used for pain and inflammation. Depending on the form, that may be arthritis, period pain, acute pain, strains and sprains, or migraine attacks. Check that your produ...
  • Take oral forms by mouth and apply gels, solutions and patches to the skin as directed. Use the lowest dose for the shortest time that works. Food won't change how much you absorb,...
  • Stomach upset, nausea, gas, diarrhea or constipation, headache and dizziness are common. Skin products can cause dryness, redness or irritation where applied. Call me or your docto...
  • Get emergency help for chest pain, trouble breathing, weakness on one side, black or bloody stools, vomiting blood, or swelling of the face or tongue. Stop it and call for a new ra...
📖 Read our full Diclofenac guide →
1
Nutrient depletion considerations

Diclofenac Sodium may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Diclofenac Sodium nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.5711 $57.11 / 100 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
80425-0234-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 100 g in 1 TUBE 2023-01-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Diclofenac Sodium 30 mg/g 00472-1783-10 Actavis 1 tube $0.368 AB Availability likely —
diclofenac sodium 30 mg/g 45802-0111-01 Padagis 1 tube $0.368 AB Availability likely —
Diclofenac Sodium 30 mg/g 62332-0581-31 Alembic 1 tube $0.368 AB Availability likely —
Diclofenac Sodium 30 mg/g 68462-0355-94 GLENMARK 1 tube $0.368 AB Availability likely —
Diclofenac Sodium 30 mg/g 00115-1483-56 Amneal 1 tube — — Discontinued —
Diclofenac Sodium 30 mg/g 45865-0260-01 Medsource 100 g — AB FDA listed —
Diclofenac Sodium 30 mg/g 46708-0581-31 Alembic 1 tube — AB FDA listed —
Diclofenac sodium 30 mg/g 51672-1363-03 Sun 1 tube — AB FDA listed —
diclofenac sodium 30 mg/g 63629-2526-01 Bryant 1 tube — AB FDA listed —
Diclofenac Sodium 30 mg/g 68071-3516-01 NuCare 1 tube — AB FDA listed —
Diclofenac sodium 30 mg/g 68071-3688-01 NuCare 1 tube — AB FDA listed —
diclofenac sodium 30 mg/g 68071-4859-01 NuCare 100 g — AB FDA listed —
Diclofenac sodium 30 mg/g 68788-8236-01 Preferred 1 tube — AB FDA listed —
Diclofenac Sodium 30 mg/g 68788-8456-01 Preferred 1 tube — AB FDA listed —
Diclofenac Sodium 30 mg/g 68788-9435-01 Preferred 1 tube — AB FDA listed —
diclofenac sodium 30 mg/g 70518-2526-00 REMEDYREPACK 1 tube — AB FDA listed —
Diclofenac Sodium 30 mg/g 70518-3315-00 REMEDYREPACK 1 tube — AB FDA listed —
Diclofenac Sodium 30 mg/g 70518-3779-00 REMEDYREPACK 1 tube — AB FDA listed —
Diclofenac sodium 30 mg/g 71205-0538-00 Proficient 1 tube — AB FDA listed —
diclofenac sodium 30 mg/g 71205-0692-00 Proficient 1 tube — AB FDA listed —
Diclofenac Sodium 30 mg/g 71205-0752-00 Proficient 1 tube — AB FDA listed —
diclofenac sodium 30 mg/g 72162-1391-01 Bryant 1 tube — AB FDA listed —
Diclofenac Sodium 30 mg/g 72189-0040-01 Direct_Rx 1 g — AB FDA listed —
Diclofenac Sodium Gel 30 mg/g 72189-0379-01 Direct_Rx 1 g — AB FDA listed —
Diclofenac Sodium Gel 30 mg/g 72189-0473-01 Direct_Rx 1 g — AB FDA listed —
Diclofenac Sodium 30 mg/g 76420-0025-01 Asclemed 100 g — — FDA listed —
Diclofenac Sodium 30 mg/g 76420-0132-01 Asclemed 100 g — AB FDA listed —
Diclofenac Sodium 30 mg/g 76420-0261-01 Asclemed 1 tube — AB FDA listed —
Diclofenac sodium 30 mg/g 76420-0275-01 Asclemed 100 g — AB FDA listed —
Diclofenac Sodium 30 mg/gthis 80425-0234-01 Advanced 1 tube — — FDA listed —
Diclofenac Sodium 30 mg/g 80425-0235-01 Advanced 1 tube — AB FDA listed —
Diclofenac Sodium 30 mg/g 80425-0236-01 Advanced 1 tube — AB FDA listed —
Diclofenac Sodium 30 mg/g 80425-0338-01 Advanced 1 tube — AB FDA listed —
Diclofenac Sodium 30 mg/g 82804-0052-00 Proficient 1 tube — AB FDA listed —
Diclofenac Sodium 30 mg/g 82804-0250-00 Proficient 1 tube — AB FDA listed —
Diclofenac Sodium 30 mg/g 85509-1581-01 PHOENIX 1 tube — AB FDA listed —
Diclofenac Sodium 30 mg/g 87063-0165-01 ASCLEMED 1 tube — AB FDA listed —
Diclofenac sodium 30 mg/g 68788-4118-01 Preferred 1 tube — AB FDA listed —
Diclofenac Sodium 30 mg/g 85534-0089-00 HAWAII 1 tube — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Jan 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAdvanced Rx Pharmacy of Tennessee, LLC
Application holderAMNEAL PHARMACEUTICALS LLC
FDA applicationANDA200936 (ANDA)
Labeler code80425
First marketedJan 2023
Product typeHuman Prescription Drug
Portfolio254 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Medication Guide 🔬 Clinical Studies 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 23 words ▾

Indications and Usage Diclofenac Sodium Gel, 3% is indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy.

⏱️ Dosage and Administration 113 words ▾

Dosage and Administration Diclofenac Sodium Gel, 3% is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site.

Assure that enough Diclofenac Sodium Gel, 3% is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site. The recommended duration of therapy is from 60 days to 90 days.

Complete healing of the lesion(s) or optimal therapeutic effect may not be evident for up to 30 days following cessation of therapy. Lesions that do not respond to therapy should be carefully re-evaluated and management reconsidered.v

⛔ Contraindications 44 words ▾

Contraindications Diclofenac Sodium Gel, 3% is contraindicated in patients with a known hypersensitivity to diclofenac, benzyl alcohol and/or polyethylene glycol monomethyl ether 350. Diclofenac Sodium Gel, 3% is contraindicated in the following patients: - In the setting of coronary artery bypass graft (CABG) surgery.

⚠️ Warnings and Cautions ~3 min read ▾

Warnings and Precautions As with other NSAIDs, anaphylactoid reactions may occur in patients without prior exposure to diclofenac. Diclofenac sodium should be given with caution to patients with the aspirin triad. The triad typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs.

Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.

However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.

To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as diclofenac, increases the risk of serious gastrointestinal (GI) events. Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10–14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.

NSAIDs are contraindicated in the setting of CABG. Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients.

Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up. Avoid the use of diclofenac sodium gel, 3% in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If diclofenac sodium gel, 3% is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

Heart Failure and Edema The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death. Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs.

Use of diclofenac may blunt the CV effects of several therapeutic agents used to treat these medical condition… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~4 min read ▾

Adverse Reactions Of the 423 patients evaluable for safety in adequate and well-controlled trials, 211 were treated with diclofenac sodium gel, 3% drug product and 212 were treated with a vehicle gel. Eighty-seven percent (87%) of the diclofenac sodium gel, 3%-treated patients (183 patients) and 84% of the vehicle-treated patients (178 patients) experienced one or more adverse events (AEs) during the studies. The majority of these reactions were mild to moderate in severity and resolved upon discontinuation of therapy.

Of the 211 patients treated with diclofenac sodium gel, 3%, 172 (82%) experienced AEs involving skin and the application site compared to 160 (75%) vehicle-treated patients. Application site reactions (ASRs) were the most frequent AEs in both diclofenac sodium gel, 3%-and vehicle-treated groups. Of note, four reactions, contact dermatitis, rash, dry skin and exfoliation (scaling) were significantly more prevalent in the diclofenac sodium gel, 3% group than in the vehicle-treated patients.

Eighteen percent of diclofenac sodium gel, 3%-treated patients and 4% of vehicle-treated patients discontinued from the clinical trials due to adverse events (whether considered related to treatment or not). These discontinuations were mainly due to skin irritation or related cutaneous adverse reactions. Table 1 below presents the AEs reported at an incidence of >1% for patients treated with either diclofenac sodium gel, 3% or vehicle (60- and 90-day treatment groups) during the phase 3 studies.

Table 1. Adverse Events Reported (>1% in Any Treatment Group) During Diclofenac Sodium Gel, 3% Phase 3 Clinical Trials Incidences for 60-Day and 90-Day Treatments 60-day Treatment 90-day Treatment Diclofenac Sodium Gel, 3% (%) N=48 Gel Vehicle (%) N=49 Diclofenac Sodium Gel, 3% (%) N=114 Gel Vehicle (%) N=114 BODY AS A WHOLE 21 20 20 18 Abdominal Pain 2 0 1 0 Accidental Injury 0 0 4 2 Allergic Reaction 0 0 1 3 Asthenia 0 0 2 0 Back Pain 4 0 2 2 Chest Pain 2 0 1 0 Chills 0 2 0 0 Flu Syndrome 10 6 1 4 Headache 0 6 7 6 Infection 4 6 4 5 Neck Pain 0 0 2 0 Pain 2 0 2 2 CARDIOVASCULAR SYSTEM 2 4 3 1 Hypertension 2 0 1 0 Migraine 0 2 1 0 Phlebitis 0 2 0 0 DIGESTIVE SYSTEM 4 0 6 8 Constipation 0 0 0 2 Diarrhea 2 0 2 3 Dyspepsia 2 0 3 4 METABOLICS AND NUTRITIONAL DISORDERS 2 8 7 2 Creatine Phosphokinase Increased 0 0 4 1 Creatinine Increased 2 2 0 1 Edema 0 2 0 0 Hypercholesteremia 0 2 1 0 Hyperglycemia 0 2 1 0 SGOT Increased 0 0 3 0 SGPT Increased 0 0 2 0 MUSCULOSKELETAL SYSTEM 4 0 3 4 Arthralgia 2 0 0 2 Arthrosis 2 0 0 0 Myalgia 2 0 3 1 NERVOUS SYSTEM 2 2 2 5 Anxiety 0 2 0 1 Dizziness 0 0 0 4 Hypokinesia 2 0 0 0 RESPIRATORY SYSTEM 8 8 7 6 Asthma 2 0 0 0 Dyspnea 2 0 2 0 Pharyngitis 2 8 2 4 Pneumonia 2 0 0 1 Rhinitis 2 2 2 2 Sinusitis 0 0 2 0 SKIN AND APPENDAGES 75 86 86 71 Acne 0 2 0 1 Application Site Reaction 75 71 84 70 Acne 0 4 1 0 Alopecia 2 0 1 1 Contact Dermatitis 19 4 33 4 Dry Skin 27 12 25 17 Edema 4 0 3 0 Exfoliation 6 4 24 13 Hyperesthesia 0 0 3 1 Pain 15 22 26 30 Paresthesia 8 4 20 20 Photosensitivity Reaction 0 2 3 0 Pruritus 31 59 52 45 Rash 35 20 46 17 Vesiculobullous Rash 0 0 4 1 Contact Dermatitis 2 0 0 0 Dry Skin 0 4 3 0 Herpes Simplex 0 2 0 0 Maculopapular Rash 0 2 0 0 Pain 2 2 1 0 Pruritus 4 6 4 1 Rash 2 10 4 0 Skin Carcinoma 0 6 2 2 Skin Nodule 0 2 0 0 Skin Ulcer 2 0 1 0 SPECIAL SENSES 2 0 4 2 Conjunctivitis 2 0 4 1 Eye Pain 0 2 2 0 UROGENITAL SYSTEM 0 0 4 5 Hematuria 0 0 2 1 OTHER 0 0 0 3 Procedure 0 0 0 3 Skin and Appendages Adverse Events Reported for diclofenac sodium gel, 3% at Less Than 1% Incidence in the Phase 3 Studies: skin hypertrophy, paresthesia, seborrhea, urticaria, application site reactions (skin carcinoma, hypertonia, skin hypertrophy lacrimation disorder, maculopapular rash, purpuric rash, vasodilation).

Adverse Reactions Reported for Oral Diclofenac Dosage Form (not topical diclofenac sodium gel, 3%): *Incidence Greater than 1% marked with asterisk. Body as a Whole: abdominal pain or cramps*, headache*,… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 119 words ▾

Overdosage Due to the low systemic absorption of topically-applied diclofenac sodium gel, 3%, overdosage is unlikely. There have been no reports of ingestion of diclofenac sodium gel, 3%. In the event of oral ingestion, resulting in significant systemic side effects, it is recommended that the stomach be emptied by vomiting or lavage.

Forced diuresis may theoretically be beneficial because the drug is excreted in the urine. The effect of dialysis or hemoperfusion in the elimination of diclofenac (99% protein-bound) remains unproven. In addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption of diclofenac.

Supportive and symptomatic treatment should be given for complications such as renal failure, convulsions, gastrointestinal irritation and respiratory depression.

🧬 Clinical Pharmacology ~2 min read ▾

Clinical Pharmacology The mechanism of action of diclofenac sodium in the treatment of actinic keratoses (AK) is unknown. The contribution to efficacy of individual components of the vehicle has not been established. Pharmacokinetics Absorption When diclofenac sodium gel, 3% is applied topically, diclofenac is absorbed into the epidermis.

In a study in patients with compromised skin (mainly atopic dermatitis and other dermatitic conditions) of the hands, arms or face, approximately 10% of the applied dose (2 grams of 3% gel over 100 cm2) of diclofenac was absorbed systemically in both normal and compromised epidermis after seven days, with four times daily applications. After topical application of 2 g diclofenac sodium gel, 3% three times daily for six days to the calf of the leg in healthy subjects, diclofenac could be detected in plasma. Mean bioavailability parameters were AUC0-t 9±19 ng/hr/mL (mean±SD) with a Cmax of 4±5 ng/mL and a Tmax of 4.5±8 hours.

In comparison, a single oral 75 mg dose of diclofenac (Voltaren®)† produced an AUC of 1600 ng/hr/mL. Therefore, the systemic bioavailability after topical application of diclofenac sodium gel, 3% is lower than after oral dosing. Comparative bioavailability studies have not been conducted between available diclofenac topical products (gels containing 1 to 3% diclofenac) which have different dosing regimens.

A cross-study evaluation of the data indicates that diclofenac is more bioavailable when applied to diseased skin and less bioavailable when applied to intact skin. Blood drawn at the end of treatment from 60 patients with AK lesions treated with diclofenac sodium gel, 3% in three adequate and well-controlled clinical trials was assayed for diclofenac levels. Each patient was administered 0.5 g of diclofenac sodium gel, 3% twice a day for up to 105 days.

There were up to three 5 cm X 5 cm treatment sites per patient on the face, forehead, hands, forearm, and scalp. Serum concentrations of diclofenac were, on average, at or below 20 ng/mL. These data indicate that systemic absorption of diclofenac in patients treated topically with diclofenac sodium gel, 3% is much lower than that occurring after oral daily dosing of diclofenac sodium.

No information is available on the absorption of diclofenac when diclofenac sodium gel, 3% is used under occlusion. Distribution Diclofenac binds tightly to serum albumin. The volume of distribution of diclofenac following oral administration is approximately 550 mL/kg.

Metabolism Biotransformation of diclofenac following oral administration involves conjugation at the carboxyl group of the side chain or single or multiple hydroxylations resulting in several phenolic metabolites, most of which are converted to glucuronide conjugates. Two of these phenolic metabolites are biologically active, however to a much smaller extent than diclofenac. Metabolism of diclofenac following topical administration is thought to be similar to that after oral administration.

The small amounts of diclofenac and its metabolites appearing in the plasma following topical administration makes the quantification of specific metabolites imprecise. Elimination Diclofenac and its metabolites are excreted mainly in the urine after oral dosing. Systemic clearance of diclofenac from plasma is 263±56 mL/min (mean±SD).

The terminal plasma half-life is 1 to 2 hours. Four of the metabolites also have short terminal half-lives of 1 to 3 hours.

📦 How Supplied / Storage and Handling 93 words ▾

How Supplied Available in tubes of 100 g. Each gram of gel contains 30 mg of diclofenac sodium. 100g tube NDC: 80425-0234-01 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Protect from heat. Avoid freezing. To report SUSPECTED ADVERSE REACTIONS contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. †Voltaren® is a registered trademark of Novartis.

Manufactured by: Tolmar, Inc. Fort Collins, CO 80526 Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 04006125 Rev. 0 04/19

📋 Description 120 words ▾

Description Diclofenac Sodium Gel, 3%, contains the active ingredient, diclofenac sodium, in a clear, transparent, colorless to slightly yellow gel base. Diclofenac sodium is a white to slightly yellow crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water, slightly soluble in acetone, and partially insoluble in ether.

The chemical name for diclofenac sodium is: Sodium [o-(2,6-dichloranilino) phenyl] acetate Diclofenac sodium has a molecular weight of 318.13. The CAS number is CAS-15307-79-6. The structural formula is represented below: Diclofenac Sodium Gel, 3% also contains benzyl alcohol, hydroxyethyl cellulose, methoxypolyethylene glycol 350, PEG-60 hydrogenated castor oil, and purified water.

1 g of Diclofenac Sodium Gel, 3% contains 30 mg of the active substance, diclofenac sodium. Description

💬 Medication Guide ~3 min read ▾

Medguide DICLOFENAC (DYE KLOE’ FEN AK) SODIUM GEL, 3% What is the most important information I should know about Diclofenac Sodium Gel, 3% and medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? Diclofenac Sodium Gel, 3% is an NSAID medicine that is used on the skin only (topical). Do not use Diclofenac Sodium Gel, 3% in or on the eyes.

NSAIDs can cause serious side effects, including: Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:< >with increasing doses of NSAIDs with longer use of NSAIDs Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: anytime during use without warning symptoms that may cause death The risk of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” increasing doses of NSAIDs longer use of NSAIDs smoking drinking alcohol older age poor health advanced liver disease bleeding problems NSAIDs should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed What is Diclofenac Sodium Gel, 3%?

Diclofenac Sodium Gel, 3% is an NSAID that is used on the skin (topical) to treat a skin condition called actinic keratosis. Diclofenac Sodium Gel, 3% is not for use in children. Who should not use Diclofenac Sodium Gel, 3%?

Do not use Diclofenac Sodium Gel, 3%: if you have had an allergic reaction to any of the ingredients in Diclofenac Sodium Gel, 3%. See the end of this Medication Guide for a complete list of ingredients in Diclofenac Sodium Gel, 3%. right before or after heart bypass surgery. Before using Diclofenac Sodium Gel, 3%, tell your healthcare provider about all of your medical conditions, including if you: have liver or kidney problems have high blood pressure have asthma are pregnant or plan to become pregnant.

Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take or use NSAIDs after 29 weeks of pregnancy. are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will use Diclofenac Sodium Gel, 3% or breastfeed.

You should not do both. Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects.

Do not start taking any new medicine without talking to your healthcare provider first. How should I use Diclofenac Sodium Gel, 3%? Use Diclofenac Sodium Gel, 3% exactly as your healthcare provider tells you to use it.

Apply Diclofenac Sodium Gel, 3% 2 times a day. Apply enough Diclofenac Sodium Gel, 3% to cover each skin lesion and gently rub in. Diclofenac Sodium Gel, 3% may be used for 60 to 90 days.

You may not see improvement of skin lesions for up to 30 days after stopping treatment. See your healthcare provider if lesions do not respond to treatment. Wash your hands after applying Diclofenac Sodium Gel, 3%.

What should I avoid while using Diclofenac Sodium Gel, 3%? Avoid spending time in sunlight or artificial light, such as tanning beds or sunlamps. Diclofenac Sodium Gel, 3% can make your skin sensitive to sunlight and the light from tanning beds and sunlamps.

You should avoid applying Diclofenac Sodium Gel, 3% to open skin wounds, skin infections, or peeling skin. What are the possible side effects of Diclofenac Sodium Gel, 3%? Diclofenac Sodium Gel, 3% and other NSAIDs can cause serious side effects, including: See “What is the most important information I should know about Diclofenac Sodium Gel, 3% and medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? new or worse high blood pressure heart failure liver problems including liver fail… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~2 min read ▾

Clinical Studies Clinical trials were conducted involving a total of 427 patients (213 treated with diclofenac sodium gel, 3% and 214 with a gel vehicle). Each patient had no fewer than five AK lesions in a major body area, which was defined as one of five 5 cm X 5 cm regions: scalp, forehead, face, forearm and hand. Up to three major body areas were studied in any patient.

All patients were 18 years of age or older (male and female) with no clinically significant medical problems outside of the AK lesions and had undergone a 60-day washout period from disallowed medications (masoprocol, 5-fluorouracil, cyclosporine, retinoids, trichloroacetic acid/lactic acid/peel, 50% glycolic acid peel) and hyaluronan-containing cosmetics. Patients were excluded from participation for reasons of known or suspected hypersensitivity to any diclofenac sodium gel, 3% ingredient, pregnancy, allergies to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), or other dermatological conditions which might affect the absorption of the study medication.

Application of dermatologic products such as sunscreens, cosmetics, and other drug products was not permitted. Patients were instructed to apply a small amount of diclofenac sodium gel, 3% (approximately 0.5 g) onto the affected skin, using their fingers, and gently smoothing the gel over the lesion. In addition, all patients were instructed to avoid sun exposure.

Complete clearing of the AK lesions 30 days after completion of treatment was the primary efficacy variable. No long-term patient follow-ups, after the 30-day assessments, were performed for the detection of recurrence. Complete Clearance of Actinic Keratosis Lesions 30 Days Post-Treatment (all locations) Diclofenac Sodium Gel, 3% Vehicle p-value Study 1 90 days treatment 27/58 (47%) 11/59 (19%) <0.001 Study 2 90 days treatment 18/53 (34%) 10/55 (18%) 0.061 Study 3 60 days treatment 15/48 (31%) 5/49 (10%) 0.021 30 days treatment 7/49 (14%) 2/49 (4%) 0.221 Complete Clearance of Actinic Keratosis Lesions 30 Days Post-Treatment (by location) Scalp Forehead Face Arm/Forearm Back of Hand Study 1 90 days treatment Diclofenac Sodium Gel, 3% 1/4 (25%) 17/30 (57%) 9/17 (53%) 4/12 (33%) 6/16 (38%) Vehicle 3/9 (33%) 8/24 (33%) 5/17 (29%) 4/12 (33%) 0/14 (0) p-value 0.7646 0.0908 0.1682 1.000 0.0650 Study 2 90 days treatment Diclofenac Sodium Gel, 3% 2/6 (33%) 9/19 (47%) 4/5 (80%) 5/8 (63%) 1/17 (6%) Vehicle 0/4 (0) 6/22 (27%) 2/8 (25%) 0/5 (0) 3/16 (19%) p-value 0.4235 0.1870 0.0727 0.0888 0.2818 Study 3 60 days treatment Diclofenac Sodium Gel, 3% 3/7 (43%) 13/31 (42%) 10/19 (53%) 0/1 (0) 2/8 (25%) Vehicle 0/6 (0) 5/36 (14%) 2/13 (15%) 0/2 (0) 1/9 (11%) p-value 0.2271 0.0153 0.0433 - 0.4637 30 days treatment Diclofenac Sodium Gel, 3% 2/5 (40%) 4/29 (14%) 3/14 (21%) 0/0 (0) 0/9 (0) Vehicle 0/5 (0) 2/29 (7%) 2/18 (11%) 0/1 (0) 1/9 (11%) p-value 0.2299 0.3748 0.4322 - 0.6521 All data combined Diclofenac Sodium Gel, 3% 8/22 (36%) 43/109 (39%) 26/55 (47%) 9/21 (43%) 9/50 (18%) Vehicle 3/24 (13%) 21/111 (19%) 11/56 (20%) 4/20 (20%) 5/48 (10%) p-value 0.0903 0.0013 0.0016 0.2043 0.3662

📄 Package Label / Principal Display Panel 5 words ▾

Principal Display Panel label 1

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Diclofenac Sodium — the program that covers self-administered drugs. 19 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Diclofenac Sodium. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$30M
Claims incl. refills
804.1K
Beneficiaries
539.2K
Spend / beneficiary
$55.63
Spend / claim
$37.30
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Advanced Rx Pharmacy of Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Advanced Rx Pharmacy of Tennessee, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 80425-0233-01 · Advanced 80425-0235-01 · Advanced →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.