Home › NDC Lookup › Ingredients › Diclofenac Sodium › 82868-0114-30
Diclofenac Sodium 75 mg Tablet, Delayed Release, 30-count — NDC 82868-0114-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Diclofenac Sodium 75 mg Tablet, Delayed Release, 30-count — NDC 82868-114-30 (Billing 82868-0114-30)

by Northwind Health Company, LLC · 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC

This is a package of 30 tablets of Diclofenac Sodium 75 mg Tablet, Delayed Release from Northwind Health Company, LLC, marketed since Aug 2026 and currently FDA-listed. It is this product's only package size.

NDC 82868-0114-30
🏷️ FDA NDC (as labeled) 82868-114-30 billing pads the product 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 Sep 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) 82868-114-30
Product NDC 82868-114
11-digit billing NDC 82868011430
RxCUI 855926
UNII QTG126297Q
Application # ANDA075281
SPL Set ID 5990259d-2f90-20d3-e063-6394a90a3d23
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 2026-08-17
Route ORAL
Dosage form TABLET, DELAYED RELEASE
Substance DICLOFENAC SODIUM
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 855926
Why two NDCs? The FDA registers this code as 82868-114-30 — a 5-3-2 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 product segment → 82868-0114-30. 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 eachPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
82868-0114-30 You're viewing this Main listing 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC 2026-08-17 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Diclofenac Sodium Delayed Release 75 mg 61442-0103-01 Carlsbad 100 tablets $0.062 AB Availability likely —
Diclofenac Sodium 75 mg 16571-0201-06 Rising 60 tablets $0.062 AB Availability likely —
Diclofenac Sodium 75 mg 70512-0784-60 SOLA 60 tablets $0.062 AB Availability likely —
Diclofenac Sodium 75 mg 72888-0111-00 Advagen 1000 tablets $0.062 AB Availability likely —
Diclofenac Sodium 75 mg 60687-0658-01 American 1 tablet $0.062 AB Availability likely —
Diclofenac Sodium 75 mg 68001-0281-00 BluePoint 100 tablets $0.062 AB Availability likely —
Diclofenac Sodium 75 mg 72603-0604-01 NorthStar 60 tablets $0.062 AB Availability likely —
Diclofenac Sodium 75 mg 00228-2551-06 Actavis 60 tablets $0.062 AB Availability likely —
Diclofenac Sodium 75 mg 59651-0843-01 Aurobindo 100 tablets $0.062 AB Availability likely —
Diclofenac Sodium Delayed Release 75 mg 61442-0227-01 Carlsbad 100 tablets $0.062 AB Availability likely —
Diclofenac Sodium 75 mg 63187-0761-15 Proficient 15 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release Delayed Release 75 mg 70882-0128-30 Cambridge 30 tablets — AB Discontinued —
Diclofenac Sodium Delayed Release 75 mg 71205-0991-00 Proficient 100 tablets — AB FDA listed —
Diclofenac Sodium 75 mg 50090-6924-00 A-S 90 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release 75 mg 63187-0222-15 Proficient 15 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release 75 mg 63629-2011-01 Bryant 500 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release 75 mg 63629-2012-01 Bryant 1000 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release 75 mg 63629-2013-01 Bryant 100 tablets — AB FDA listed —
Diclofenac Sodium DR 75 mg 80425-0189-01 Advanced 60 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release 75 mg 85509-1103-03 PHOENIX 30 tablets — AB FDA listed —
Diclofenac Sodium 75 mg 85766-0010-01 Sportpharm 100 tablets — AB FDA listed —
Diclofenac Sodium 75 mg 50090-7855-00 A-S 100 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release 75 mg 51407-0538-01 Golden 100 tablets — AB FDA listed —
Diclofenac Sodium 75 mg 55289-0150-10 PD-Rx 10 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release 75 mg 68788-9806-01 Preferred 100 tablets — AB FDA listed —
Diclofenac Sodium 75 mg 50090-7646-00 A-S 100 tablets — AB FDA listed —
Diclofenac Sodium 75 mg 67296-0990-01 RedPharm 21 tablets — AB Discontinued —
Diclofenac Sodium 75 mg 68788-8193-01 Preferred 100 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release 75 mg 70518-4602-00 REMEDYREPACK 30 tablets — AB FDA listed —
Diclofenac Sodium 75 mg 85509-1201-03 PHOENIX 30 tablets — AB FDA listed —
Diclofenac Sodium 75 mg 35356-0714-20 Quality 20 tablets — AB Discontinued —
Diclofenac Sodium 75 mg 50090-7856-00 A-S 90 tablets — AB FDA listed —
Diclofenac Sodium 75 mg 67296-2151-08 Redpharm 28 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release 75 mg 68071-4934-04 NuCare 14 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release 75 mg 71335-0357-00 Bryant 40 tablets — AB Discontinued —
Diclofenac Sodium Delayed Release 75 mg 70518-1104-02 REMEDYREPACK 30 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release 75 mg 72162-1734-01 Bryant 100 tablets — AB FDA listed —
Diclofenac Sodium 75 mg 76420-0670-00 Asclemed 1000 tablets — AB FDA listed —
Diclofenac Sodium 75 mg 50090-7647-00 A-S 90 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release 75 mg 51655-0176-26 Northwind 90 tablets — AB FDA listed —
Diclofenac Sodium 75 mg 66267-0071-14 NuCare 14 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release 75 mg 68071-4117-02 NuCare 20 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release 75 mg 70518-0627-00 REMEDYREPACK 30 tablets — AB Discontinued —
Diclofenac Sodium 75 mg 71335-0456-00 Bryant 40 tablets — AB FDA listed —
Diclofenac Sodium 75 mg 71335-2684-00 Bryant 40 tablets — AB FDA listed —
Diclofenac Sodium 75 mg 42291-0231-10 AvKARE 1000 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release 75 mg 50090-0545-00 A-S 100 tablets — AB FDA listed —
Diclofenac Sodium 75 mg 60760-0090-15 St. 15 tablets — AB FDA listed —
Diclofenac Sodium 75 mg 63187-0012-15 Proficient 15 tablets — AB FDA listed —
Diclofenac Sodium 75 mg 67296-1197-02 RedPharm 20 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release 75 mg 50090-7838-00 A-S 100 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release 75 mg 50090-7839-00 A-S 90 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release 75 mg 51407-0968-01 Golden 100 tablets — AB FDA listed —
Diclofenac Sodium 75 mg 60429-0422-01 Golden 100 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release 75 mg 61145-0102-06 REPHARM 60 tablets — AB Discontinued —
Diclofenac Sodium Delayed Release 75 mg 67296-2215-01 Redpharm 20 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release 75 mg 50090-7818-00 A-S 90 tablets — AB FDA listed —
Diclofenac Sodium DR 75 mg 80425-0055-01 Advanced 60 tablets — AB FDA listed —
Diclofenac Sodium 75 mg 80425-0564-01 Advanced 30 tablets — AB FDA listed —
Diclofenac Sodium 75 mg 60290-0084-01 Umedica 60 tablets — AB FDA listed —
Diclofenac Sodium 75 mg 67046-1482-03 Coupler 30 tablets — AB FDA listed —
Diclofenac Sodium 75 mg 72789-0578-30 PD-Rx 30 tablets — AB FDA listed —
Diclofenac Sodium 75 mgthis 82868-0114-30 Northwind 30 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release 75 mg 68788-4194-01 Preferred 100 tablets — 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

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

What it looks like

Color pink
ShapeRound
ImprintD75
Size1 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 6T47AS764T
    Red 40 Lake is a synthetic colorant made by combining Red 40 dye with aluminum hydroxide. It's used to give tablets, capsules, and other medicines a red or pink color for identification and appearance.
  • UNII GYP6Z2JR6Q
    FD&C Yellow No. 6 Aluminum Lake is a yellow colorant made by combining FD&C Yellow No. 6 dye with aluminum salts. It's used to color tablets, capsules, and other medicines so they're easier to identify.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 36SFW2JZ0W
    Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
  • UNII 0VUT3PMY82
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. In medicines, it forms protective coatings on tablets or capsules, controls how fast the drug releases, and thickens liquid formulations.
  • UNII 1IVH67816N
    Hypromellose 2910 is a plant-derived cellulose compound used as a thickener and film-former in medicines. It helps control how quickly the medication dissolves and creates protective coatings on tablets or capsules.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 4R4HFI6D95
    Polyethylene glycol 4000 is a synthetic polymer derived from petroleum. It serves as a binder, filler, and lubricant in solid dosage forms, and helps control how quickly the medicine dissolves.
  • UNII Q662QK8M3B
    Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

20 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerNorthwind Health Company, LLC
Application holderAUROBINDO PHARMA USA INC
FDA applicationANDA075281 (ANDA)
Labeler code82868
First marketedAug 2026
Product typeHuman Prescription Drug
Portfolio578 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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide ⚠️ Precautions 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 140 words ▾

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS CARDIOVASCULAR THROMBOTIC EVENTS Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS ). Diclofenac sodium delayed-release tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS , WARNINGS ).

GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events (see WARNINGS ).

🎯 Indications and Usage 90 words ▾

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac sodium delayed-release tablets are indicated: for relief of the signs and symptoms of osteoarthritis for relief of the signs and symptoms of rheumatoid arthritis for acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis

⏱️ Dosage and Administration 201 words ▾

DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ). After observing the response to initial therapy with diclofenac sodium delayed-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.

For the relief of osteoarthritis, the recommended dosage is 100 to 150 mg/day in divided doses (50 mg twice a day or three times a day, or 75 mg twice a day). For the relief of rheumatoid arthritis, the recommended dosage is 150 to 200 mg/day in divided doses (50 mg three times a day. or four times a day, or 75 mg twice a day.). For the relief of ankylosing spondylitis, the recommended dosage is 100 to 125 mg/day, administered as 25 mg four times a day, with an extra 25 mg dose at bedtime if necessary.

Different formulations of diclofenac [(diclofenac sodium enteric-coated tablets); diclofenac sodium extended-release tablets; diclofenac potassium immediate-release tablets)] are not necessarily bioequivalent even if the milligram strength is the same.

⛔ Contraindications 94 words ▾

CONTRAINDICATIONS Diclofenac sodium delayed-release tablets are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product (see WARNINGS; Anaphylactic Reactions , Serious Skin Reactions ). History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients (see WARNINGS; Anaphylactic Reaction , Exacerbation of Asthma Related to Aspirin Sensitivity ).

In the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS; Cardiovascular Thrombotic Events ).

⚠️ Warnings ~3 min read ▾

WARNINGS Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to 3 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 (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ). 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 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.

NSAIDs are contraindicated in the setting of CABG (see CONTRAINDICATIONS ). 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 delayed-release tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If diclofenac sodium delayed-release tablets are used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs, including diclofenac, cause serious gastrointestinal (GI) adverse events, including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic.

Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3 to 6 months, and in about 2% to 4% of patients treated for one year. However, even short-term therapy is not without risk. Risk Factors for GI Bleeding, Ulceration, and Perforation Patients with a prior history of peptic ulcer disease and/or GI bleeding who use NSAIDs had a greater than 10-fold increased risk for developing… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events (see WARNINGS ) GI Bleeding, Ulceration and Perforation (see WARNINGS ) Hepatotoxicity (see WARNINGS ) Hypertension (see WARNINGS ) Heart Failure and Edema (see WARNINGS ) Renal Toxicity and Hyperkalemia (see WARNINGS ) Anaphylactic Reactions (see WARNINGS ) Serious Skin Reactions (see WARNINGS ) Hematologic Toxicity (see WARNINGS ) Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In patients taking diclofenac sodium delayed-release tablets, or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1% to 10% of patients are: Gastrointestinal experiences, including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal), and vomiting. Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes, and tinnitus. Additional adverse experiences reported occasionally include: Body as a Whole: fever, infection, sepsis Cardiovascular System: congestive heart failure, hypertension, tachycardia, syncope Digestive System: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice Hemic and Lymphatic System: ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia Metabolic and Nutritional: weight changes Nervous System: anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo Respiratory System: asthma, dyspnea Skin and Appendages: alopecia, photosensitivity, sweating increased Special Senses: blurred vision Urogenital System: cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure Other adverse reactions, which occur rarely are: Body as a Whole: anaphylactic reactions, appetite changes, death Cardiovascular System: arrhythmia, hypotension, myocardial infarction, palpitations, vasculitis Digestive System: colitis, eructation, fulminant hepatitis with and without jaundice, liver failure, liver necrosis, pancreatitis Hemic and Lymphatic System: agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia Metabolic and Nutritional: hyperglycemia Nervous System: convulsions, coma, hallucinations, meningitis Respiratory System: respiratory depression, pneumonia Skin and Appendages: angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, fixed drug eruption (FDE), urticaria Special Senses: conjunctivitis, hearing impairment

🔄 Drug Interactions ~2 min read ▾

Drug Interactions See Table 2 for clinically significant drug interactions with diclofenac. Table 2. Clinically Significant Drug Interactions with Diclofenac Drugs That Interfere with Hemostasis Clinical Impact: Diclofenac and anticoagulants, such as warfarin have a synergistic effect on bleeding.

The concomitant use of diclofenac and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.

Intervention: Monitor patients with concomitant use of diclofenac sodium delayed-release tablets with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding (see PRECAUTIONS ; Hematological Toxicity ). Aspirin Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone.

In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ). Intervention: Concomitant use of diclofenac sodium delayed-release tablets and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding (see PRECAUTIONS : Hematological Toxicity ). Diclofenac sodium delayed-release tablets are not a substitute for low dose aspirin for cardiovascular protection.

ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact: NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, coadministration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.

Intervention: During concomitant use of diclofenac sodium delayed-release tablets and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. During concomitant use of diclofenac sodium delayed-release tablets and ACE-inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function (see WARNINGS; Renal Toxicity and Hyperkalemia). When these drugs are administered concomitantly, patients should be adequately hydrated.

Assess renal function at the beginning of the concomitant treatment and periodically thereafter. Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.

Intervention: During concomitant use of diclofenac sodium delayed-release tablets with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy, including antihypertensive effects (see WARNINGS; Renal Toxicity and Hyperkalemia ). Digoxin Clinical Impact: The concomitant use of diclofenac with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Intervention: During concomitant use of diclofenac sodium delayed-release tablets and digoxin, monitor serum digoxin levels.

Lithium Clinical Impact: NSAIDs have produced elevations in plasma… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

Pregnancy Risk Summary Use of NSAIDs, including diclofenac sodium delayed-release tablets, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of diclofenac sodium delayed-release tablets use between about 20 and 30 weeks of gestation, and avoid diclofenac sodium delayed-release tablets use at about 30 weeks of gestation and later in pregnancy (see WARNINGS; Fetal Toxicity ).

Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including diclofenac sodium delayed-release tablets, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. There are no adequate and well-controlled studies of diclofenac sodium delayed-release tablets in pregnant women.

Data from observational studies regarding potential embryo-fetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In animal reproduction studies, no evidence of teratogenicity was observed in mice, rats, or rabbits given diclofenac during the period of organogenesis at doses up to approximately 0.5, 0.5, and 1 times, respectively, the maximum recommended human dose (MRHD) of diclofenac sodium delayed-release tablets, 200 mg/day, despite the presence of maternal and fetal toxicity at these doses (see Data) .

Based on published animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors, such as diclofenac, resulted in increased pre- and post-implantation loss. Prostaglandins also have been shown to have an important role in fetal kidney development.

In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including diclofenac sodium delayed-release tablets, can cause premature closure of the fetal ductus arteriosus (see WARNINGS; Fetal Toxicity ).

Oligohydramnios/Neonatal Renal Impairment: If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. If diclofenac sodium delayed-release tablets treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue diclofenac sodium delayed-release tablets and follow up according to clinical practice (see WARNINGS; Fetal Toxicity ).

Data Human Data Premature Closure of Fetal Ductus Arteriosus: Published literature reports that the use of NSAIDs at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment: Published studies and post-marketing reports describe maternal NSAID use at about 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. These adverse outcomes… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 134 words ▾

Geriatric Use Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects (see WARNINGS; Cardiovascular Thrombotic Events , Gastrointestinal Bleeding, Ulceration, and Perforation , Hepatotoxicity , Renal Toxicity and Hyperkalemia , PRECAUTIONS; Laboratory Monitoring ).

Diclofenac is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY , ADVERSE REACTIONS ).

🆘 Overdosage 156 words ▾

OVERDOSAGE Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression and coma have occurred, but were rare (see WARNINGS; Cardiovascular Thrombotic Events , Gastrointestinal Bleeding, Ulceration, and Perforation , Hypertension , Renal Toxicity and Hyperkalemia ).

Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdose (5 to 10 times the recommended dosage).

Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. For additional information about overdosage treatment, contact a poison control center (1-800-222-1222).

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Mechanism of Action Diclofenac has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of diclofenac sodium delayed-release tablets, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Diclofenac is a potent inhibitor of prostaglandin synthesis in vitro .

Diclofenac concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation.

Because diclofenac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues. Pharmacokinetics Absorption Diclofenac is 100% absorbed after oral administration compared to intravenous (IV) administration as measured by urine recovery. However, due to first-pass metabolism, only about 50% of the absorbed dose is systemically available (see Table 1).

Food has no significant effect on the extent of diclofenac absorption. However, there is usually a delay in the onset of absorption of 1 to 4.5 hours and a reduction in peak plasma levels of less than 20%. Table 1.

Pharmacokinetic Parameters for Diclofenac PK Parameter Normal Healthy Adults (20 to 48 years) Mean Coefficient of Mean Variation (%) Absolute bioavailability (%) [N = 7] 55 40 T max (hr) [N = 56] 2.3 69 Oral clearance (CL/F; mL/min) [N = 56] 582 23 Renal clearance (% unchanged drug in urine) [N = 7] < 1 — Apparent volume of distribution (V/F; L/kg) [N = 56] 1.4 58 Terminal half-life (hr) [N = 56] 2.3 48 Distribution The apparent volume of distribution (V/F) of diclofenac sodium is

1.4L/kg. Diclofenac is more than 99% bound to human serum proteins, primarily to albumin. Serum protein binding is constant over the concentration range (0.15 to 105 mcg/mL) achieved with recommended doses.

Diclofenac diffuses into and out of the synovial fluid. Diffusion into the joint occurs when plasma levels are higher than those in the synovial fluid, after which the process reverses and synovial fluid levels are higher than plasma levels. It is not known whether diffusion into the joint plays a role in the effectiveness of diclofenac.

Elimination Metabolism Five diclofenac metabolites have been identified in human plasma and urine. The metabolites include 4’-hydroxy-, 5-hydroxy-, 3’-hydroxy-, 4’,5-dihydroxy- and 3’-hydroxy-4’-methoxy diclofenac. The major diclofenac metabolite, 4'-hydroxy-diclofenac, has very weak pharmacologic activity.

The formation of 4’-hydroxy- diclofenac is primarily mediated by CYP2C9. Both diclofenac and its oxidative metabolites undergo glucuronidation or sulfation followed by biliary excretion. Acyl glucuronidation mediated by UGT2B7 and oxidation mediated by CYP2C8 may also play a role in diclofenac metabolism.

CYP3A4 is responsible for the formation of minor metabolites, 5-hydroxy- and 3’-hydroxy-diclofenac. In patients with renal dysfunction, peak concentrations of metabolites 4’-hydroxy- and 5-hydroxy-diclofenac were approximately 50% and 4% of the parent compound after single oral dosing compared to 27% and 1% in normal healthy subjects. Excretion Diclofenac is eliminated through metabolism and subsequent urinary and biliary excretion of the glucuronide and the sulfate conjugates of the metabolites.

Little or no free unchanged diclofenac is excreted in the urine. Approximately 65% of the dose is excreted in the urine and approximately 35% in the bile as conjugates of unchanged diclofenac plus metabolites. Because renal elimination is not a significant pathway of elimination for unchanged diclofenac, dosing adjustment in patients with mild to moderate renal dysfunction is not necessary.

The terminal half-life of unchanged diclofenac is approximately 2 hours. Special Populations Pediatric: The pharmacokinetics of diclofenac sodium delayed-release tablets has not been investigated in pedi… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 112 words ▾

HOW SUPPLIED Diclofenac Sodium Delayed-Release Tablets, USP are available containing 75 mg of diclofenac sodium, USP. The 75 mg tablets are pale pink, round, biconvex, enteric coated tablet imprinted “D75” in black ink on one side and plain on other side. They are available as follows: Bottles of 30 NDC 82868-114-30 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.

Dispense in a tight, light-resistant container as described in the USP using a child-resistant closure. Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides. Distributed by: Aurobindo Pharma USA, Inc.

279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 01/2025

📋 Description 177 words ▾

DESCRIPTION Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C.

The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C 14 H 10 Cl 2 NNaO 2 , and it has the following structural formula.

The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake.

The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze. Chemical Structure

💬 Information for Patients ~3 min read ▾

Information for Patients Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information before initiating therapy with diclofenac sodium delayed-release tablets and periodically during the course of ongoing therapy. Cardiovascular Thrombotic Events Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately (see WARNINGS; Cardiovascular Thrombotic Events ).

Gastrointestinal Bleeding, Ulceration, and Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for the signs and symptoms of GI bleeding (see WARNING; Gastrointestinal Bleeding, Ulceration, and Perforation ). Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and “flu-like” symptoms).

If these occur, instruct patients to stop diclofenac sodium delayed-release tablets and seek immediate medical therapy (see WARNINGS; Hepatotoxicity ). Heart Failure and Edema Advise patients to be alert for the symptoms of congestive heart failure, including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur (see WARNINGS; Heart Failure and Edema ). Anaphylactic Reactions Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat).

Instruct patients to seek immediate emergency help if these occur (see WARNINGS; Anaphylactic Reactions ). Serious Skin Reactions, Including DRESS Advise patients to stop diclofenac sodium delayed-release tablets immediately if they develop any type of rash or fever and contact their healthcare provider as soon as possible (see WARNINGS; Serious Skin Reactions ). Female Fertility Advise females of reproductive potential who desire pregnancy that NSAIDs, including diclofenac sodium delayed-release tablets, may be associated with a reversible delay in ovulation (see PRECAUTIONS; Carcinogenesis, Mutagenesis, Impairment of Fertility ).

Fetal Toxicity Inform pregnant women to avoid use of diclofenac sodium delayed-release tablets and other NSAIDs, starting at 30 weeks gestation because of the risk of the premature closure of the fetal ductus arteriosus. If treatment with diclofenac sodium delayed-release tablets are needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours. (see WARNINGS; Fetal Toxicity , PRECAUTIONS , Pregnancy ).

Avoid Concomitant Use of NSAIDs Inform patients that the concomitant use of diclofenac sodium delayed-release tablets with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation and Drug Interactions ). Alert patients that NSAIDs may be present in “over the counter” medications for treatment of colds, fever, or insomnia. Use of NSAIDS and Low-Dose Aspirin Inform patients not to use low-dose aspirin concomitantly with diclofenac sodium delayed-release tablets until they talk to their healthcare provider (see PRECAUTIONS; Drug Interactions ).

Masking of Inflammation and Fever The pharmacological activity of diclofenac sodium delayed-release tablets in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting in… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides. Medication Guide Diclofenac Sodium (dye kloe' fen ak soe' dee um) Delayed-Release Tablets, USP What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? 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 Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).” Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: any time 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 older age longer use of NSAIDs poor health smoking advanced liver disease drinking alcohol bleeding problems NSAIDs should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed What are NSAIDs?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions, such as different types of arthritis, menstrual cramps, and other types of short-term pain. Who should not take NSAIDs? Do not take NSAIDs: if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. right before or after heart bypass surgery.

Before taking NSAIDs, 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. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby.

You should not take NSAIDs after about 30 weeks of pregnancy. are breastfeeding or plan to breastfeed. 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. What are the possible side effects of NSAIDs? NSAIDs can cause serious side effects, including: See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?” new or worse high blood pressure heart failure liver problems, including liver failure kidney problems, including kidney failure low red blood cells (anemia) life-threatening skin reactions life-threatening allergic reactions Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, dizziness Get emergency help right away if you have any of the following symptoms: shortness of breath or trouble breathing slurred speech chest pain swelling of the face or throat weakness in one part or side of your body Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: nausea vomit blood more tired or weaker than usual there is blood in your bowel movement or it is black and sticky like tar diarrhea unusual weight gain itching skin rash or blisters with fever your skin or eyes look yellow swelling of t… [Excerpted — this section continues on DailyMed.]

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Diclofenac sodium delayed-release tablets cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids and the patient should be observed closely for any evidence of adverse effects, including adrenal insufficiency and exacerbation of symptoms of arthritis.

The pharmacological activity of diclofenac sodium delayed-release tablets in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions. Information for Patients Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information before initiating therapy with diclofenac sodium delayed-release tablets and periodically during the course of ongoing therapy.

Cardiovascular Thrombotic Events Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately (see WARNINGS; Cardiovascular Thrombotic Events ). Gastrointestinal Bleeding, Ulceration, and Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider.

In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for the signs and symptoms of GI bleeding (see WARNING; Gastrointestinal Bleeding, Ulceration, and Perforation ). Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, instruct patients to stop diclofenac sodium delayed-release tablets and seek immediate medical therapy (see WARNINGS; Hepatotoxicity ).

Heart Failure and Edema Advise patients to be alert for the symptoms of congestive heart failure, including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur (see WARNINGS; Heart Failure and Edema ). Anaphylactic Reactions Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur (see WARNINGS; Anaphylactic Reactions ).

Serious Skin Reactions, Including DRESS Advise patients to stop diclofenac sodium delayed-release tablets immediately if they develop any type of rash or fever and contact their healthcare provider as soon as possible (see WARNINGS; Serious Skin Reactions ). Female Fertility Advise females of reproductive potential who desire pregnancy that NSAIDs, including diclofenac sodium delayed-release tablets, may be associated with a reversible delay in ovulation (see PRECAUTIONS; Carcinogenesis, Mutagenesis, Impairment of Fertility ).

Fetal Toxicity Inform pregnant women to avoid use of diclofenac sodium delayed-release tablets and other NSAIDs, starting at 30 weeks gestation because of the risk of the premature closure of the fetal ductus arteriosus. If treatment with diclofenac sodium delayed-release tablets are needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours. (see WARNINGS; Fetal Toxicity , PRECAUTIONS , Pregnancy ).

Avoid Concomitant Use of NSAIDs Inform patients that the concomitant use of diclofenac sodium delayed-release tablets with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is no… [Excerpted — this section continues on DailyMed.]

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term carcinogenicity studies in rats given diclofenac sodium up to 2 mg/kg/day (approximately 0.1 times maximum recommended human dose (MRHD) of diclofenac sodium delayed-release tablets, 200 mg/day, based on body surface area (BSA) comparison) have revealed no significant increases in tumor incidence. A 2-year carcinogenicity study conducted in mice employing diclofenac sodium at doses up to 0.3 mg/kg/day (approximately 0.007 times the MRHD based on BSA comparison) in males and 1 mg/kg/day (approximately 0.02 times the MRHD based on BSA comparison) in females did not reveal any oncogenic potential.

Mutagenesis Diclofenac sodium did not show mutagenic activity in in vitro point mutation assays in mammalian (mouse lymphoma) and microbial (yeast, Ames) test systems and was nonmutagenic in several mammalian in vitro and in vivo tests, including dominant lethal and male germinal epithelial chromosomal studies in mice, and nucleus anomaly and chromosomal aberration studies in Chinese hamsters. Impairment of Fertility Diclofenac sodium administered to male and female rats at 4 mg/kg/day (approximately 0.2 times the MRHD based on BSA comparison) did not affect fertility.

Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including diclofenac sodium delayed-release tablets, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation. Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation.

Consider withdrawal of NSAIDs, including diclofenac sodium delayed-release tablets, in women who have difficulties conceiving or who are undergoing investigation of infertility.

📄 Package Label / Principal Display Panel 6 words ▾

Principal Display Panel NDC: 82868-114-30 label

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 ✓ Available
Inactive ingredients (structured) ✓ 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 ✓ Available
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 Northwind Health Company, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Northwind Health Company, 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.
← 82868-0112-30 · Northwind 82868-0115-20 · Northwind →
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.