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Diclofenac Sodium Delayed Release 75 mg Tablet, Delayed Release, 100-count — NDC 68788-4194-1 (Billing 68788-4194-01)

by Preferred Pharmaceuticals Inc. · 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC

This is a package of 100 tablets of Diclofenac Sodium Delayed Release 75 mg Tablet, Delayed Release from Preferred Pharmaceuticals Inc., marketed since Sep 2026 and currently FDA-listed. It is the main listing for this product, which comes in 5 package sizes.

NDC 68788-4194-01
🏷️ FDA NDC (as labeled) 68788-4194-1 billing pads the package segment with a zero
This package
Contains100-count Pack sizes5 compare ↓
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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) 68788-4194-1
Product NDC 68788-4194
11-digit billing NDC 68788419401
Application # ANDA075185
SPL Set ID bc99e6af-7050-4653-a681-5b252305a970
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 2026-09-24
Route ORAL
Dosage form TABLET, DELAYED RELEASE
Substance DICLOFENAC SODIUM
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 68788-4194-1 — 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 → 68788-4194-01. 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.

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.

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.
Try another pack size: 12 tablets 30 tablets 60 tablets 90 tablets
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
68788-4194-01 You're viewing this Main listing 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC 2026-09-24 — Active
68788-4194-03 68788-4194-3 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC 2026-09-24 — Active
68788-4194-06 68788-4194-6 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC 2026-09-24 — Active
68788-4194-08 68788-4194-8 12 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC 2026-09-24 — Active
68788-4194-09 68788-4194-9 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC 2026-09-24 — Active

You're viewing the largest of 5 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet, delayed release in 1 bottle, plastic.
How does this package differ from NDC 68788-4194-08?
Both are Diclofenac Sodium Delayed Release 75 mg Tablet, Delayed Release — the drug itself is identical. This page's package is the 100-count one, while NDC 68788-4194-08 is the 12 tablets package.
What NDC number is used to bill for this package of Diclofenac Sodium Delayed Release 75 mg Tablet, Delayed Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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 mg 82868-0114-30 Northwind 30 tablets — AB FDA listed —
Diclofenac Sodium Delayed Release 75 mgthis 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
Sep 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.

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

LabelerPreferred Pharmaceuticals Inc.
Application holderCARLSBAD TECHNOLOGY INC
FDA applicationANDA075185 (ANDA)
Labeler code68788
First marketedSep 2026
Product typeHuman Prescription Drug
Portfolio833 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. Jump with a chip, search within the label, or expand everything.
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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 (matched by generic name) — 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. CMS lists 3 products for this generic; we show the highest-spend one. 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 ✓ 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 Preferred Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 12 tablets (68788-4194-08), 30 tablets (68788-4194-03), 60 tablets (68788-4194-06). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Preferred Pharmaceuticals Inc. 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.
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.