Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Diclofenac Sodium Delayed Release 75 mg Tablet, Delayed Release, 30-count — NDC 68788-4194-3 (Billing 68788-4194-03)
by Preferred Pharmaceuticals Inc. · 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC
This is a package of 30 tablets of Diclofenac Sodium Delayed Release 75 mg Tablet, Delayed Release from Preferred Pharmaceuticals Inc., marketed since Sep 2026 and currently FDA-listed.
NDC 68788-4194-03
🏷️ FDA NDC (as labeled)
68788-4194-3
billing pads the package segment with a zero
This package
Contains30-count
Pack sizes5 compare ↓
Product page 68788-4194-01
Also comes in:
12 tablets 68788-4194-8
60 tablets 68788-4194-6
90 tablets 68788-4194-9
100 tablets 68788-4194-1
🗂️ 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)
68788-4194-3
Product NDC
68788-4194
11-digit billing NDC
68788419403
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 68788-4194-3 — 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 → 68788-4194-03. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Diclofenac Sodium — tap one for details:
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about Diclofenac Sodium?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per each | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 68788-4194-01 68788-4194-1 Main listing | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | 2026-09-24 | — | Active |
| 68788-4194-03 You're viewing this | 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 one of 5 pack sizes for this product.
Pack size FAQ
What quantity is in this package?
This is a 30-count package — 30 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 30-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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 68788-4194-03 | Preferred | 30 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
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.
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Color
white
ShapeRound
Imprint7
Size1 mm
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.
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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 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 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
-
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 74G4R6TH13
A synthetic polymer made by combining two plastic-like chemicals. It forms a coating on tablets or capsules that dissolves at a specific point in the digestive tract, controlling where and when the medicine releases.
-
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 HAF0412YIT
Polyethylene glycol 2000 is a synthetic liquid polymer used as a solvent, humectant, and lubricant in medications. It helps dissolve active ingredients, retain moisture, and improve how the medicine flows during manufacturing.
-
UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
-
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 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
-
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.
12 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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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 ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
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 | ✓ 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 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), 60 tablets (68788-4194-06), 90 tablets (68788-4194-09). 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.