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Sertraline 100 mg Tablet, Film Coated, 100-count — NDC 68788-8669-01 package photo

Sertraline 100 mg Tablet, Film Coated, 100-count

by Preferred Pharmaceuticals Inc. · 100 TABLET, FILM COATED in 1 BOTTLE (68788-8669-1)
NDC 68788-8669-01
🏷️ FDA NDC (as labeled) 68788-8669-1 billing pads the package segment with a zero
This package
Contains100-count Pack sizes6 compare ↓
Also comes in: 28 tablets 68788-8669-02 30 tablets 68788-8669-03 60 tablets 68788-8669-06 90 tablets 68788-8669-09 120 tablets 68788-8669-08
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Sep 25, 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Sep 2025. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 68788-8669-1
Product NDC 68788-8669
11-digit billing NDC 68788866901
NCPDP billing unit EA — each (per item)
Application # ANDA077670
SPL Set ID a7854be8-c5c0-47e3-9b7f-a5134393045c
Established class (EPC) Serotonin Reuptake Inhibitor
Mechanism of action Cytochrome P450 2D6 Inhibitors; Serotonin Uptake Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Sep 2025)
Marketing start 2024-05-20
Route ORAL
Dosage form TABLET, FILM COATED
Substance SERTRALINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 68788-8669-1 — 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 → 68788-8669-01. 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.

🏭 Manufacturer & labeler

LabelerPreferred Pharmaceuticals Inc.
Application holderLUPIN LTD
FDA applicationANDA077670 (ANDA)
Labeler code68788
First marketedMay 2024
Product typeHuman Prescription Drug
Portfolio826 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.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Sertraline is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks), posttraumatic stress disorder (disturbing psychological symptoms that develop after a frightening experience), and social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life). It is also used to relieve the symptoms of premenstrual dysphoric disorder, (mood swings, irrita...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Most people don't feel the full benefit right away — sertraline typically takes several weeks to build up to steady levels in your body. Some people notice small improvements in sl...
  • How long does it take for sertraline to start working?
  • You should be cautious. Sertraline affects the blood's ability to clot, and combining it with aspirin, ibuprofen, naproxen, or other anti-inflammatory pain relievers raises your ri...
  • Is it okay to take sertraline with ibuprofen or aspirin?
📖 Read our full Sertraline guide →
1
Nutrient depletion considerations

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

🧪 Full Sertraline 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.

💊 What it looks like

Color Yellow
ShapeCapsule
ImprintL;U;D03
Size13 mm
ScoringScored — splits in 2
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 L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • 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 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 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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 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.
  • UNII CHI530446X
    Vanillin is a natural or synthetic aromatic compound that gives vanilla flavor. It's used in medicines as a flavoring agent to mask bitter tastes and improve how the medicine tastes.

11 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.

💲 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: 28 tablets 30 tablets 60 tablets 90 tablets 120 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sertraline Hydrochloride 100 mg 16729-0217-15 Accord 90 tablets $0.050 AB Availability likely —
Sertraline Hydrochloride 100 mg 00904-6926-61 Major 1 tablet $0.051 AB Availability likely —
Sertraline Hydrochloride 100 mg 16714-0613-01 NorthStar 30 tablets $0.051 AB Availability likely —
Sertraline Hydrochloride 100 mg 31722-0147-05 Camber 500 tablets $0.051 — Availability likely —
Sertraline 100 mg 50268-0770-15 AvPAK 1 tablet $0.051 AB Availability likely —
Sertraline Hydrochloride 100 mg 50268-0825-15 AvPAK 1 tablet $0.051 AB Availability likely —
Sertraline Hydrochloride 100 mg 60687-0253-01 American 100 tablets $0.051 AB Availability likely —
Sertraline Hydrochloride 100 mg 65862-0013-01 Aurobindo 100 tablets $0.051 — Availability likely —
Sertraline Hydrochloride 100 mg 68180-0992-01 Lupin 30 tablets $0.051 AB Availability likely —
Sertraline Hydrochloride 100 mg 68645-0523-54 Legacy 30 tablets $0.051 AB Availability likely —
Sertraline Hydrochloride 100 mg 69097-0835-02 Cipla 30 tablets $0.051 AB Availability likely —
Sertraline hydrochloride 100 mg 70010-0205-03 Granules 30 tablets $0.051 AB Availability likely —
Sertraline 100 mg 76282-0214-01 Exelan 100 tablets $0.051 AB Discontinued —
Sertraline Hydrochloride 100 mg 82009-0050-05 Quallent 500 tablets $0.051 AB Availability likely —
Zoloft 100 mg 58151-0576-88 Viatris 1 tablet $14.943 AB Availability likely —
Zoloft 100 mg 00049-4910-30 ROERIG 30 tablets $14.947 AB Discontinued —
Sertraline Hydrochloride 100 mg 00615-8604-05 NCS 15 tablets — AB FDA listed —
Sertraline 100 mg 23155-0759-03 Heritage 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 43063-0754-30 PD-Rx 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 43353-0447-15 Aphena 15 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 43602-0981-15 Ascent 30 tablets — — FDA listed —
Sertraline 100 mg 50090-0991-00 A-S 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 50090-2080-00 A-S 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 50090-3203-00 A-S 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 50090-6917-00 A-S 90 tablets — AB FDA listed —
Sertraline 100 mg 50090-7295-00 A-S 90 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 50090-7693-00 A-S 30 tablets — — FDA listed —
Sertraline Hydrochloride 100 mg 50090-7694-00 A-S 90 tablets — — FDA listed —
Sertraline Hydrochloride 100 mg 50090-7700-00 A-S 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 50090-7701-00 A-S 90 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 50228-0469-05 ScieGen 500 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 51655-0173-26 Northwind 90 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 55154-3570-00 Cardinal 1 tablet — AB FDA listed —
Sertraline Hydrochloride 100 mg 55154-4692-00 Cardinal 10 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 55700-0362-30 Quality 30 tablets — AB Discontinued —
Sertraline Hydrochloride 100 mg 60760-0091-90 St. 90 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 60760-0738-90 St. 90 tablets — AB FDA listed —
Sertraline 100 mg 63187-0212-30 Proficient 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 63187-0795-30 Proficient 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 67046-0554-03 Coupler 30 tablets — AB FDA listed —
Sertraline hydrochloride 100 mg 67046-1682-03 Coupler 30 tablets — AB FDA listed —
Sertraline 100 mg 68071-3534-03 NuCare 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 68071-4658-03 NuCare 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 68071-4973-06 NuCare 60 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 68180-0353-01 Lupin 100 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 68788-6835-01 Preferred 100 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 68788-8210-03 Preferred 30 tablets — AB FDA listed —
Sertraline 100 mgthis 68788-8669-01 Preferred 100 tablets — AB Discontinued —
Sertraline 100 mg 70518-1040-00 REMEDYREPACK 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 70518-2448-00 REMEDYREPACK 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 70518-4590-00 REMEDYREPACK 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 71205-0047-30 Proficient 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 71205-0455-30 Proficient 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 71335-0210-01 Bryant 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 71335-0510-01 Bryant 30 tablets — AB Discontinued —
Sertraline Hydrochloride 100 mg 71335-0896-01 Bryant 30 tablets — AB Discontinued —
Sertraline Hydrochloride 100 mg 71335-3110-01 Bryant 30 tablets — AB FDA listed —
Sertraline 100 mg 71335-3115-01 Bryant 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 71610-0433-15 Aphena 15 tablets — AB Discontinued —
Sertraline Hydrochloride 100 mg 71610-0435-45 Aphena 45 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 71610-0651-15 Aphena 15 tablets — AB FDA listed —
Sertraline 100 mg 71610-0769-15 Aphena 15 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 71610-0886-15 Aphena 15 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 72162-2407-03 Bryant 30 tablets — AB FDA listed —
Sertraline 100 mg 72162-2411-00 Bryant 1000 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 72189-0122-30 DIRECT 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 72789-0088-60 PD-Rx 60 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 72789-0092-30 PD-Rx 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 72789-0273-01 PD-Rx 100 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 72865-0207-05 XLCare 500 tablets — — FDA listed —
Sertraline Hydrochloride 100 mg 76420-0786-01 Asclemed 100 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 80425-0310-01 Advanced 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 84386-0099-59 Aurobindo 5000 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

🏛️
2024
On the market since
May 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Sertraline — the ingredient across all brands.

Top reported reactions

Nausea13,865
Fatigue12,822
Headache11,106
Anxiety10,369
Diarrhoea10,339
Dizziness9,602
Depression9,506

Age at onset

Neonate667
Infant107
Child310
Adolescent1,168
Adult16,853
Elderly8,818

Reporter sex

218,320 reports
Male · 33%
Female · 67%
Unknown · 0%

Serious outcomes

Hospitalization68,335
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 16,834 6,832
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68788-8669-01 You're viewing this 100 TABLET, FILM COATED in 1 BOTTLE (68788-8669-1) 2024-05-20 Discontinued by firm
68788-8669-02 28 TABLET, FILM COATED in 1 BOTTLE (68788-8669-2) 2024-05-20 Discontinued by firm
68788-8669-03 30 TABLET, FILM COATED in 1 BOTTLE (68788-8669-3) 2024-05-20 Discontinued by firm
68788-8669-06 60 TABLET, FILM COATED in 1 BOTTLE (68788-8669-6) 2024-05-20 Discontinued by firm
68788-8669-08 120 TABLET, FILM COATED in 1 BOTTLE (68788-8669-8) 2024-05-20 Discontinued by firm
68788-8669-09 90 TABLET, FILM COATED in 1 BOTTLE (68788-8669-9) 2024-05-20 Discontinued by firm

You're viewing one of 6 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 68788-8669-01?
NDC 68788-8669-01 is a 100-count package — 100 tablet, film coated in 1 bottle.
What is the difference between NDC 68788-8669-01 and NDC 68788-8669-02?
Both are Sertraline 100 mg Tablet, Film Coated — the drug itself is identical. NDC 68788-8669-01 is the 100-count package, while NDC 68788-8669-02 is the 28 tablets package.
What NDC number is used to bill for this package of Sertraline 100 mg Tablet, Film Coated?
Bill NDC 68788-8669-01 — the 11-digit billing format is 68788866901. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 FDA registers it as 68788-8669-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68788-8669-01, written without dashes as 68788866901. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 68788-8669-01, the first segment (68788) is the labeler code FDA assigned to Preferred Pharmaceuticals Inc.; the middle segment (8669) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 5 other package presentations of this same product, including 28 tablets (68788-8669-02), 30 tablets (68788-8669-03), 60 tablets (68788-8669-06). 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.

📄 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
📄 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 ↗
← 68788-8668-01 · Preferred 68788-8670-09 · Preferred →
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.