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(from DailyMed)

atorvastatin calcium 40 mg Tablet, Film Coated, 160-count

by Pfizer Pharmaceuticals LLC · 1 BAG in 1 DRUM (65427-257-40) / 160 TABLET, FILM COATED in 1 BAG
NDC 65427-0257-40
🏷️ FDA NDC (as labeled) 65427-257-40 billing pads the product segment with a zero
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 Atorvastatin Calcium (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 19, 2025 — Failed Dissolution Specifications (Ascend Laboratories, LLC) · FDA recall D-0020-2026
Class II · Sep 19, 2025 — Failed Dissolution Specifications (Ascend Laboratories, LLC) · FDA recall D-0019-2026
Class II · Sep 19, 2025 — Failed Dissolution Specifications (Ascend Laboratories, LLC) · FDA recall D-0017-2026
Class II · Sep 19, 2025 — Failed Dissolution Specifications (Ascend Laboratories, LLC) · FDA recall D-0018-2026
Class II · Mar 17, 2025 — Failed dissolution specifications: lower than specifications (BIOCON PHARMA INC) · FDA recall D-0306-2025
Class II · Mar 16, 2023 — CGMP Deviations (Northwind Pharmaceuticals LLC) · FDA recall D-0548-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 65427-257-40
Product NDC 65427-257
11-digit billing NDC 65427025740
SPL Set ID 2b5e24e5-d010-4dda-bdc6-720513364f73
DEA schedule Non-controlled
Marketing category EXPORT ONLY
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-11-21
Dosage form TABLET, FILM COATED
Substance ATORVASTATIN CALCIUM TRIHYDRATE
Why two NDCs? The FDA registers this code as 65427-257-40 — 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 → 65427-0257-40. 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

LabelerPfizer Pharmaceuticals LLC
Labeler code65427
First marketedNov 2019
Product typeDrug For Further Processing
Portfolio10 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 mainly lowers your LDL — the "bad" cholesterol — and triglycerides, while nudging your HDL ("good" cholesterol) a little higher. Over time, keeping those numbers in a healthier...
  • What exactly is atorvastatin supposed to do for me?
  • Honestly, no — the cholesterol-lowering effect is the same whether you take it in the morning or at night, and whether you eat beforehand or not. The most important thing is that y...
  • Does it matter what time of day I take it, or whether I eat first?
📖 Read our full Atorvastatin guide →
2
Nutrient depletion considerations

Atorvastatin Calcium may be associated with lower levels of 2 nutrients — 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.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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.
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
Atorvastatin Calcium 40 mg 55111-0123-05 Dr. 500 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 42571-0174-10 Micro 1000 tablets $0.037 AB Discontinued —
Atorvastatin Calcium 40 mg 70377-0079-11 Biocon 90 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 43598-0101-05 Dr. 500 tablets $0.037 AB Availability likely —
atorvastatin calcium 40 mg 70710-1772-00 Zydus 1000 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 72603-0284-01 NorthStar 90 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 00093-5058-10 Teva 1000 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 50228-0453-10 ScieGen 1000 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 00480-3587-10 Teva 1000 tablets $0.037 AB Availability likely —
Atorvastatin calcium 40 mg 72603-0405-02 NorthStar 100 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 51079-0210-20 Mylan 1 tablet $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 67877-0513-05 Ascend 500 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 42385-0942-01 Laurus 100 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 00378-3952-05 Mylan 500 tablets $0.037 AB Availability likely —
Atorvastatin calcium 40 mg 70756-0249-12 Lifestar 1000 tablets $0.037 AB Availability likely —
Atorvastatin calcium 40 mg 72205-0024-05 Novadoz 500 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 82009-0178-10 Quallent 1000 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 31722-0426-05 Camber 500 tablets $0.037 AB Availability likely —
Atorvastatin calcium 40 mg 33342-0317-10 Macleods 90 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 43598-0832-05 Dr. 500 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 63304-0829-05 Sun 500 tablets $0.040 — FDA listed —
Atorvastatin Calcium 40 mg 69097-0946-05 Cipla 90 tablets $0.068 AB FDA listed —
Atorvastatin Calcium 40 mg 68180-0637-02 Lupin 500 tablets $0.068 — Discontinued —
Atorvastatin Calcium 40 mg 16729-0046-15 Accord 90 tablets $0.068 AB FDA listed —
Lipitor 40 mg 58151-0157-77 Viatris 90 tablets $19.114 AB Availability likely —
Atorvastatin Calcium 40 mg 69097-0899-05 Cipla 90 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 71205-0264-30 Proficient 30 tablets — — FDA listed —
Atorvastatin Calcium 40 mg 71610-0163-15 Aphena 15 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 50090-5632-00 A-S 30 tablets — — FDA listed —
Atorvastatin calcium 40 mg 50090-5915-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 71205-0731-30 Proficient 30 tablets — AB FDA listed —
Atorvastatin calcium 40 mg 71205-0765-30 Proficient 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 71610-0745-15 Aphena 15 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 82804-0026-30 Proficient 30 tablets — AB FDA listed —
atorvastatin calcium 40 mg 65427-0157-40 Pfizer 160 tablets — — FDA listed —
atorvastatin calcium 40 mgthis 65427-0257-40 Pfizer 160 tablets — — FDA listed —
atorvastatin calcium 40 mg 50090-7726-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 60760-0734-30 St. 30 tablets — AB FDA listed —
Atorvastatin calcium 40 mg 71335-9711-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 72162-2238-09 Bryant 90 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 72189-0239-90 DIRECT 90 tablets — — FDA listed —
Atorvastatin Calcium 40 mg 50090-5208-00 A-S 90 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 50090-7807-00 A-S 90 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 51655-0465-52 Northwind 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 68071-3667-03 NuCare 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 68071-5194-03 NuCare 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 68788-8574-09 Preferred 90 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 76420-0946-00 Asclemed 1000 tablets — AB FDA listed —
atorvastatin calcium 40 mg 82137-0018-01 Lepu 90 tablets — — FDA listed —
Atorvastatin Calcium 40 mg 60760-0882-30 St. 30 tablets — AB FDA listed —
Atorvastatin calcium 40 mg 67046-1529-03 Coupler 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 68071-2991-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin calcium 40 mg 68788-8094-01 Preferred 100 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 71209-0092-04 Cadila 90 tablets — — FDA listed —
Atorvastatin calcium 40 mg 68071-2302-03 NuCare 30 tablets — AB FDA listed —
Atorvastatin calcium 40 mg 72789-0089-30 PD-Rx 30 tablets — AB FDA listed —
Atorvastatin calcium 40 mg 82868-0048-30 Northwind 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 71335-2493-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 71335-9723-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 72189-0557-30 Direct_rx 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 42708-0005-30 QPharma, 30 tablets — AB FDA listed —
Atorvastatin calcium 40 mg 70518-3273-00 REMEDYREPACK 30 tablets — AB Discontinued —
Atorvastatin Calcium 40 mg 48433-0009-20 Safecor 1 tablet — AB FDA listed —
Atorvastatin Calcium 40 mg 50090-5207-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 68071-3595-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin calcium 40 mg 68071-3948-03 NuCare 30 tablets — AB FDA listed —
atorvastatin calcium 40 mg 70771-1877-00 Zydus 1000 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 71335-1126-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 77771-0453-10 Radha 1000 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 50090-7806-00 A-S 30 tablets — AB FDA listed —
Atorvastatin calcium 40 mg 60760-0726-30 St. 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 68071-3267-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 68071-4837-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 59651-0608-62 Aurobindo 30000 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 50090-7384-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 68071-3628-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 70518-4592-00 REMEDYREPACK 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 71335-1011-01 Bryant 30 tablets — — Discontinued —
Atorvastatin Calcium 40 mg 42708-0144-30 QPharma, 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 50090-7385-00 A-S 90 tablets — AB FDA listed —
atorvastatin calcium 40 mg 50090-7727-00 A-S 90 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 68071-5091-03 NuCare 30 tablets — AB FDA listed —
Atorvastatin calcium 40 mg 70518-4474-00 REMEDYREPACK 90 tablets — AB FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2019
On the market since
Nov 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 Atorvastatin Calcium (matched by generic name) — the program that covers self-administered drugs. 26 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 Atorvastatin Calcium. 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
$194.53M
Claims incl. refills
18.7M
Beneficiaries
14.7M
Spend / beneficiary
$13.26
Spend / claim
$10.38
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 Atorvastatin calcium — the ingredient across all brands.

Top reported reactions

Fatigue14,254
Nausea12,774
Diarrhoea11,485
Dyspnoea11,456
Type 2 Diabetes Mellitus11,261
Pain10,300
Headache10,092

Age at onset

Neonate3
Infant4
Child6
Adolescent16
Adult11,619
Elderly16,633

Reporter sex

245,963 reports
Male · 45%
Female · 54%
Unknown · 1%

Serious outcomes

Hospitalization70,080
Death18,692
Disabling7,734
Life-threatening7,358
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 10,953 5,288
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
65427-0257-40 You're viewing this 1 BAG in 1 DRUM (65427-257-40) / 160 TABLET, FILM COATED in 1 BAG — Active

🧭 About this NDC listing & data coverage

Bulk ingredient (not a finished retail product)

This is a bulk ingredient listing — not a retail prescription package

atorvastatin calcium 40 mg/1 TABLET, FILM COATED is listed with FDA as a bulk ingredient (a drug substance supplied for further manufacturing or licensed pharmacy compounding). It is not a finished product a patient would receive at a retail pharmacy, so consumer-style information — a patient label, retail pricing, package photos — generally does not exist for this NDC. The listing identifies the substance and package for supply-chain and regulatory purposes.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Export Only". Products approved under an application carry an NDA, ANDA, or BLA number.
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.
Can I get this product filled at a pharmacy?
Not as listed here. A bulk ingredient NDC identifies drug substance supplied for manufacturing or licensed compounding — it is not a finished, dispensable package. A pharmacy prescription would involve a finished product with its own NDC.
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 65427-257-40, 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: 65427-0257-40, written without dashes as 65427025740. 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 65427-0257-40, the first segment (65427) is the labeler code FDA assigned to Pfizer Pharmaceuticals LLC; the middle segment (0257) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (40) 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 Pfizer Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Pfizer Pharmaceuticals LLC 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.
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 FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label 19 words ▾

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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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.