Paroxetine 40 mg Tablet, Film Coated, 90-count
by Zydus Lifesciences Limited · 90 TABLET, FILM COATED in 1 BOTTLE (65841-601-16)
NDC 65841-0601-16
🏷️ FDA NDC (as labeled)
65841-601-16
billing pads the product segment with a zero
This package
Contains90-count
Pack sizes5 compare ↓
Also priced by: Part D plans $0.2824/unit — full pricing hub ↓
Also comes in:
30 tablets 65841-0601-06
100 tablets 65841-0601-01
500 tablets 65841-0601-05
1000 tablets 65841-0601-10
Rx only
Generic
On market
Non-controlled
🗂️ Data synced Jul 24, 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 Paroxetine Hydrochloride (different manufacturers) — 5 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 13, 2026 — Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria (Apotex Corp.) · FDA recall D-0804-2026
Class II · Nov 1, 2023 — Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine (Apotex Corp.) · FDA recall D-0121-2024
Class II · Nov 1, 2023 — Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine (Apotex Corp.) · FDA recall D-0119-2024
Class II · Nov 1, 2023 — Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine (Apotex Corp.) · FDA recall D-0120-2024
Class II · Nov 1, 2023 — Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine (Apotex Corp.) · FDA recall D-0122-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
65841-601-16
Product NDC
65841-601
11-digit billing NDC
65841060116
UNII
3I3T11UD2S
Application #
ANDA077584
SPL Set ID
6d5fcdb2-4d84-4b20-87e3-58a43e567500
Established class (EPC)
Serotonin Reuptake Inhibitor
Mechanism of action
Serotonin Uptake Inhibitors
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2007-04-13
Route
ORAL
Dosage form
TABLET, FILM COATED
Substance
PAROXETINE HYDROCHLORIDE ANHYDROUS
TE code (Orange Book)
AB · RLD · RS
Why two NDCs?
The FDA registers this code as 65841-601-16 — 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 → 65841-0601-16. 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 Serotonin Reuptake Inhibitor class.
Pharmacologic class
Serotonin Reuptake Inhibitor
Drug family (ATC)
Selective serotonin reuptake inhibitors
How it works
Serotonin Uptake 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.
🏭 Manufacturer & labeler
LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA077584 (ANDA)
Labeler code65841
First marketedApr 2007
Product typeHuman Prescription Drug
Portfolio717 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
Paroxetine is used to treat depression, panic disorder (sudden, unexpected attacks of extreme fear and worry about these attacks), social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life), obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), generalized anxiety disorder (GAD; excessive worrying that is difficult to control), and posttraumatic stress disorder (disturbing psychological symptoms that develop after a frightening experience). Paroxetine...
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- It usually takes a few weeks before you notice the full benefit — that's completely normal for this type of medication. Some people notice small improvements in sleep or energy wit...
- How long before I start feeling better on paroxetine?
- Please don't stop suddenly — paroxetine is one of the antidepressants most likely to cause discontinuation symptoms if you quit cold turkey. These can include dizziness, nausea, ir...
- Can I just stop taking paroxetine if I feel better or if it bothers me?
Patient education
Supplement & herbal interactions
1
Nutrient depletion considerations
Paroxetine 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.
💬 Questions about Paroxetine Hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
White
ShapeRound
ImprintZC18
Size11 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 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 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
-
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 30IQX730WE
Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
-
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 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.
9 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 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 · Q2 2026 | $0.2824 | $25.42 / 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Paroxetine 40 mg 00378-7004-10 | Mylan | 1000 tablets | $0.098 | AB | Availability likely | — |
| Paroxetine 40 mg 16714-0184-01 | NorthStar | 30 tablets | $0.098 | AB | Availability likely | — |
| Paroxetine 40 mg 43547-0350-03 | Solco | 30 tablets | $0.098 | AB | Availability likely | — |
| Paroxetine 40 mg 50268-0643-15 | AvPAK | 1 tablet | $0.098 | AB | Availability likely | — |
| Paroxetine 40 mg 60505-0101-01 | Apotex | 30 tablets | $0.098 | AB | Availability likely | — |
| Paroxetine 40 mg 62135-0544-90 | Chartwell | 90 tablets | $0.098 | AB | Availability likely | — |
| Paroxetine 40 mg 68084-0047-01 | American | 1 tablet | $0.098 | AB | Availability likely | — |
| paroxetine hydrochloride 40 mg 69584-0674-03 | Oxford | 30 tablets | $0.098 | AB | Availability likely | — |
| Paxil 40 mg 60505-4520-03 | Apotex | 30 tablets | $11.505 | AB | Availability likely | — |
| Paroxetine 40 mg 00615-8174-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| Paroxetine 40 mg 13107-0157-01 | Aurolife | 100 tablets | — | AB | FDA listed | — |
| Paroxetine 40 mg 43353-0544-15 | Aphena | 15 tablets | — | AB | FDA listed | — |
| Paroxetine 40 mg 55289-0053-45 | PD-Rx | 45 tablets | — | AB | FDA listed | — |
| Paroxetine 40 mg 60429-0737-10 | Golden | 1000 tablets | — | AB | FDA listed | — |
| Paroxetine 40 mg 61919-0513-90 | DIRECT | 90 tablets | — | AB | FDA listed | — |
| Paroxetine 40 mg 63187-0434-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Paroxetine 40 mg 63629-3349-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Paroxetine 40 mgthis 65841-0601-16 | Zydus | 90 tablets | — | AB | FDA listed | — |
| Paroxetine 40 mg 65862-0157-01 | Aurobindo | 100 tablets | — | AB | FDA listed | — |
| Paroxetine 40 mg 67544-0492-15 | Aphena | 15 tablets | — | AB | FDA listed | — |
| Paroxetine 40 mg 68382-0001-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Paroxetine 40 mg 68788-6870-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Paroxetine 40 mg 69117-0027-01 | Yiling | 30 tablets | — | AB | FDA listed | — |
| Paroxetine 40 mg 70518-0003-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Paroxetine 40 mg 70518-0993-01 | REMEDYREPACK | 1 tablet | — | AB | FDA listed | — |
| Paroxetine 40 mg 70518-1253-01 | REMEDYREPACK | 1 tablet | — | AB | FDA listed | — |
| Paroxetine 40 mg 71205-0198-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Paroxetine 40 mg 71610-0056-15 | Aphena | 15 tablets | — | AB | FDA listed | — |
| Paroxetine 40 mg 71610-0992-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Paroxetine 40 mg 72162-2358-09 | Bryant | 90 tablets | — | AB | FDA listed | — |
| Paroxetine 40 mg 72789-0420-90 | PD-Rx | 90 tablets | — | AB | FDA listed | — |
| Paroxetine 40 mg 76420-0719-01 | Asclemed | 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
🏛️
2007
On the market since
Apr 2007
📍
2026
Currently FDA-listed
19 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 Paroxetine hydrochloride hemihydrate — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 36%
Female · 64%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 65841-0601-01 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-601-01) | 2007-04-13 | Active |
| 65841-0601-05 | 500 TABLET, FILM COATED in 1 BOTTLE (65841-601-05) | 2007-04-13 | Active |
| 65841-0601-06 | 30 TABLET, FILM COATED in 1 BOTTLE (65841-601-06) | 2007-04-13 | Active |
| 65841-0601-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (65841-601-10) | 2007-04-13 | Active |
| 65841-0601-16 You're viewing this | 90 TABLET, FILM COATED in 1 BOTTLE (65841-601-16) | 2007-04-13 | Active |
You're viewing one of 5 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 65841-0601-16?
NDC 65841-0601-16 is a 90-count package — 90 tablet, film coated in 1 bottle.
What is the difference between NDC 65841-0601-16 and NDC 65841-0601-06?
Both are Paroxetine 40 mg Tablet, Film Coated — the drug itself is identical. NDC 65841-0601-16 is the 90-count package, while NDC 65841-0601-06 is the 30 tablets package.
What NDC number is used to bill for this package of Paroxetine 40 mg Tablet, Film Coated?
Bill NDC 65841-0601-16 — the 11-digit billing format is 65841060116. 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
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 FDA registers it as 65841-601-16, 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: 65841-0601-16, written without dashes as 65841060116. 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 65841-0601-16, the first segment (65841) is the labeler code FDA assigned to Zydus Lifesciences Limited; the middle segment (0601) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Zydus Lifesciences Limited. 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 30 tablets (65841-0601-06), 100 tablets (65841-0601-01), 500 tablets (65841-0601-05). 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?
Zydus Lifesciences Limited 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.
💬 Medication Guide ▾
SPL MEDGUIDE
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 ↗
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.