fesoterodine fumarate 8 mg Tablet, Film Coated, Extended Release
by Zydus Lifesciences Limited · 10 BLISTER PACK in 1 CARTON (70771-1169-4) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70771-1169-2)
NDC 70771-1169-04
🏷️ FDA NDC (as labeled)
70771-1169-4
billing pads the package segment with a zero
This package
Contains10 tablet, film coated, extended release in 1 blister pack
Pack sizes3 compare ↓
Also priced by: Part D plans $1.66/unit — full pricing hub ↓
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 Fesoterodine Fumarate (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Dec 16, 2025 — Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. (Alembic Pharmaceuticals Limited) · FDA recall D-0248-2026
Class III · Oct 10, 2025 — Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. (Alembic Pharmaceuticals Limited) · FDA recall D-0156-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
70771-1169-4
Product NDC
70771-1169
11-digit billing NDC
70771116904
UNII
EOS72165S7
Application #
ANDA204946
SPL Set ID
26e8cc63-1e1d-4a77-8f53-4c38bcf0d443
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2017-12-07
Route
ORAL
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Substance
FESOTERODINE FUMARATE
TE code (Orange Book)
AB · RLD · RS
Why two NDCs?
The FDA registers this code as 70771-1169-4 — 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 → 70771-1169-04. 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 Drugs for urinary frequency and incontinence class.
Drug family (ATC)
Drugs for urinary frequency and incontinence
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 applicationANDA204946 (ANDA)
Labeler code70771
First marketedDec 2017
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
📗 Our plain-language guide HelloPharmacist
- It's calming down overactive signals in your bladder muscle. When your bladder squeezes too often or too urgently, it's because certain nerve receptors are overstimulated. Fesotero...
- What is fesoterodine actually doing for my bladder?
- No, you can take it with or without food — it works either way. The one thing that does matter is how you take the tablet: swallow it whole with a glass of liquid. Don't chew, crus...
- Dry mouth is the most common side effect, and it's more noticeable at higher doses. Sipping water throughout the day, chewing sugar-free gum, or using sugar-free hard candies can h...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Fesoterodine Fumarate — tap one for details:
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 fesoterodine fumarate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
Yellow / White
ShapeOval
Imprint480
Size13 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 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 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 1DI56QDM62
A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
-
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 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
-
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 O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
-
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.
-
UNII TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
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 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 | $1.66 | $166.44 / 100 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 |
|---|---|---|---|---|---|---|
| Fesoterodine Fumarate 8 mg 31722-0034-30 | Camber | 30 tablets | $0.813 | AB | Availability likely | — |
| Fesoterodine fumarate 8 mg 43598-0248-30 | Dr.Reddy's | 30 tablets | $0.813 | AB | Availability likely | — |
| Fesoterodine Fumarate 8 mg 65862-0767-30 | Aurobindo | 30 tablets | $0.813 | AB | Availability likely | — |
| Fesoterodine Fumarate 8 mg 67877-0068-30 | Ascend | 30 tablets | $0.813 | AB | Availability likely | — |
| fesoterodine fumarate 8 mg 68382-0480-06 | Zydus | 30 tablets | $0.813 | AB | Availability likely | — |
| Fesoterodine Fumarate 8 mg 72603-0414-01 | NorthStar | 30 tablets | $0.813 | AB | Availability likely | — |
| Toviaz 8 mg 00069-0244-30 | Pfizer | 30 tablets | $9.265 | AB | Availability likely | — |
| Fesoterodine Fumarate 8 mg 46708-0176-10 | Alembic | 100 tablets | — | AB | FDA listed | — |
| Fesoterodine fumarate 8 mg 51407-0662-30 | Golden | 30 tablets | — | AB | FDA listed | — |
| Fesoterodine Fumarate 8 mg 62332-0176-10 | Alembic | 100 tablets | — | AB | FDA listed | — |
| Fesoterodine Fumarate 8 mg 65162-0370-03 | Amneal | 30 tablets | — | AB | FDA listed | — |
| fesoterodine fumarate 8 mgthis 70771-1169-04 | Zydus | 10 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
🏛️
2017
On the market since
Dec 2017
📍
2026
Currently FDA-listed
9 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.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Fesoterodine Fumarate ER (matched by generic name) — the program that covers self-administered drugs. 7 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 Fesoterodine Fumarate ER. CMS lists 2 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
$3.07M
Claims incl. refills
31K
Beneficiaries
19.5K
Spend / beneficiary
$157.85
Spend / claim
$99.15
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.
🔬 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 Fesoterodine fumarate — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 31%
Female · 68%
Unknown · 1%
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 |
|---|---|---|---|
| 70771-1169-03 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1169-3) | 2017-12-07 | Active |
| 70771-1169-04 You're viewing this | 10 BLISTER PACK in 1 CARTON (70771-1169-4) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70771-1169-2) | 2017-12-07 | Active |
| 70771-1169-09 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1169-9) | 2017-12-07 | Active |
Pack size FAQ
What quantity is in NDC 70771-1169-04?
NDC 70771-1169-04 is listed by the FDA — 10 blister pack in 1 carton / 10 tablet, film coated, extended release in 1 blister pack.
What NDC number is used to bill for this package of fesoterodine fumarate 8 mg Tablet, Film Coated, Extended Release?
Bill NDC 70771-1169-04 — the 11-digit billing format is 70771116904. 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 70771-1169-4, 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: 70771-1169-04, written without dashes as 70771116904. 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 70771-1169-04, the first segment (70771) is the labeler code FDA assigned to Zydus Lifesciences Limited; the middle segment (1169) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 2 other package presentations of this same product, including 30 tablets (70771-1169-03), 90 tablets (70771-1169-09). 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?
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.
📄 FDA label ▾
No readable label sections were found for this product.
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.