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Atorvastatin Calcium 80 mg Tablet, Film Coated, 90-count — NDC 67877-0514-90 package photo

Atorvastatin Calcium 80 mg Tablet, Film Coated, 90-count

by Ascend Laboratories, LLC · 90 TABLET, FILM COATED in 1 BOTTLE (67877-514-90)
NDC 67877-0514-90
🏷️ FDA NDC (as labeled) 67877-514-90 billing pads the product segment with a zero
This package
Contains90-count Cost per ea$0.0692 NADAC Per package$6.23 / 90 tablets Pack sizes4 compare ↓
Also priced by: Medicaid pays $0.2603/unit · Part D plans $0.0927/unit — full pricing hub ↓
Also comes in: 10 tablets 67877-0514-38 500 tablets 67877-0514-05 1000 tablets 67877-0514-10
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🚨
Active recall for this product.
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 · 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-0020-2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Atorvastatin Calcium (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
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) 67877-514-90
Product NDC 67877-514
11-digit billing NDC 67877051490
NCPDP billing unit EA — each (per item)
RxCUI 259255, 617310, 617311, 617312
UNII 48A5M73Z4Q
UPC 0367877512051, 0367877513102, 0367877514109
Application # ANDA209288
SPL Set ID 67e60880-091a-4df7-8696-6e6c42a490e2
Established class (EPC) HMG-CoA Reductase Inhibitor
Mechanism of action Hydroxymethylglutaryl-CoA Reductase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-12-23
Route ORAL
Dosage form TABLET, FILM COATED
Substance ATORVASTATIN CALCIUM TRIHYDRATE
GPI-14 39400010100350
GPI class Atorvastatin Calcium
GCN Seq No 045772
GCN 43723
HICL code 012404
Ingredient (HICL) Atorvastatin Calcium
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M4
Therapeutic class — intermediate (HIC2) Affect Blood Lipids/Sugar/Amino Acids
HIC3 code M4D
Therapeutic class — specific (HIC3) Antihyperlipidemic-Hmgcoa Reductase Inhib(Statins)
AHFS code 24:06.08.00
AHFS class Hmg-Coa Reductase Inhibitors
FDB label name ATORVASTATIN 80 MG TABLET
FDB brand name Atorvastatin Calcium
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 67877-514-90 — 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 → 67877-0514-90. 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 HMG-CoA Reductase Inhibitor class.

Pharmacologic class HMG-CoA Reductase Inhibitor
Drug family (ATC) HMG CoA reductase inhibitors
How it works Hydroxymethylglutaryl-CoA Reductase 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

LabelerAscend Laboratories, LLC
Application holderALKEM LABORATORIES LTD
FDA applicationANDA209288 (ANDA)
Labeler code67877
First marketedDec 2018
Product typeHuman Prescription Drug
Portfolio346 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

Label name ATORVASTATIN 80 MG TABLET Ingredient Atorvastatin Calcium
📗 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.

🧪 Full Atorvastatin Calcium 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 White
ShapeOval
Imprint80;ATS
Size19 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 H0G9379FGK
    Calcium carbonate is a white mineral powder used as a filler and buffering agent in medicines. It helps give tablets their bulk and size while neutralizing stomach acid in some formulations.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 5Y0974F5PW
    Hydroxypropyl cellulose is a plant-derived thickener and binder made by chemically treating cellulose. In medicines, it helps hold tablets together, thickens liquids, and can form a protective coating on capsules.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • 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 7T9FYH5QMK
    A plant-derived powder that serves as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and aids in smooth tablet disintegration when swallowed.
  • 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 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 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.

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 eaPer package
Retail pharmacies payNADAC · weekly $0.069 $6.23 / 90 tablets
Medicaid paysCMS SDUD · 12 mo $0.2603 $23.43 / 90 tablets
Medicare drug plans payPart D · Q2 2026 $0.0927 $8.34 / 90 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.107 $0.069
▼ Down 35% over the last 24 months.
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 80 mg 00093-5057-05 Teva 500 tablets $0.069 AB Availability likely —
Atorvastatin Calcium 80 mg 00378-3953-05 Mylan 500 tablets $0.069 AB Availability likely —
Atorvastatin Calcium 80 mg 00480-3588-10 Teva 1000 tablets $0.069 AB Availability likely —
Atorvastatin Calcium 80 mg 00904-6293-04 Major 1 tablet $0.069 AB Availability likely —
Atorvastatin Calcium 80 mg 16571-0139-09 Rising 90 tablets $0.069 AB Availability likely —
Atorvastatin Calcium 80 mg 16714-0176-01 NORTHSTAR 90 tablets $0.069 AB Availability likely —
Atorvastatin Calcium 80 mg 31722-0427-05 Camber 500 tablets $0.069 AB Availability likely —
Atorvastatin calcium 80 mg 33342-0318-10 Macleods 90 tablets $0.069 AB Availability likely —
Atorvastatin Calcium 80 mg 42385-0943-01 Laurus 100 tablets $0.069 AB Availability likely —
Atorvastatin Calcium 80 mg 42571-0175-10 Micro 1000 tablets $0.069 AB Discontinued —
Atorvastatin Calcium 80 mg 43598-0103-05 Dr. 500 tablets $0.069 AB Availability likely —
Atorvastatin Calcium 80 mg 43598-0833-05 Dr. 500 tablets $0.069 AB Availability likely —
Atorvastatin Calcium 80 mg 50228-0454-05 ScieGen 500 tablets $0.069 AB Availability likely —
Atorvastatin Calcium 80 mg 50268-0096-12 AvPAK 1 tablet $0.069 AB Availability likely —
Atorvastatin Calcium 80 mg 51079-0211-03 Mylan 1 tablet $0.069 AB Availability likely —
Atorvastatin Calcium 80 mg 55111-0124-05 Dr. 500 tablets $0.069 AB Availability likely —
Atorvastatin Calcium 80 mgthis 67877-0514-90 Ascend 90 tablets $0.069 AB Availability likely —
Atorvastatin Calcium 80 mg 68084-0590-25 American 1 tablet $0.069 AB Availability likely —
Atorvastatin Calcium 80 mg 70377-0080-11 Biocon 90 tablets $0.069 AB Availability likely —
atorvastatin calcium 80 mg 70710-1770-00 Zydus 1000 tablets $0.069 AB Availability likely —
Atorvastatin calcium 80 mg 72205-0025-05 Novadoz 500 tablets $0.069 AB Availability likely —
Atorvastatin Calcium 80 mg 72603-0285-01 NorthStar 90 tablets $0.069 AB Availability likely —
Atorvastatin calcium 80 mg 72603-0406-02 NorthStar 100 tablets $0.069 AB Availability likely —
Atorvastatin calcium 80 mg 75834-0258-01 NIVAGEN 1000 tablets $0.069 AB Availability likely —
Atorvastatin Calcium 80 mg 82009-0004-10 Quallent 1000 tablets $0.069 AB Availability likely —
Atorvastatin Calcium 80 mg 82009-0179-10 Quallent 1000 tablets $0.069 AB Availability likely —
Atorvastatin Calcium 80 mg 63304-0830-05 Sun 500 tablets $0.072 — FDA listed +4%
Atorvastatin Calcium 80 mg 16729-0047-15 Accord 90 tablets $0.079 AB FDA listed +14%
Atorvastatin Calcium 80 mg 69097-0947-05 Cipla 90 tablets $0.079 AB FDA listed +14%
Atorvastatin Calcium 80 mg 68180-0638-02 Lupin 500 tablets $0.079 — Discontinued +14%
Lipitor 80 mg 58151-0158-77 Viatris 90 tablets $19.004 AB Availability likely +27346%
Atorvastatin Calcium 80 mg 00615-8009-05 NCS 15 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 48433-0010-03 Safecor 1 tablet — AB FDA listed —
Atorvastatin calcium 80 mg 50090-6054-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 50090-6061-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 50090-6505-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 50090-6506-00 A-S 90 tablets — AB FDA listed —
Atorvastatin calcium 80 mg 50090-6970-00 A-S 90 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 50090-7358-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 50090-7359-00 A-S 90 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 50090-7532-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 50090-7533-00 A-S 90 tablets — AB FDA listed —
atorvastatin calcium 80 mg 50090-7724-00 A-S 30 tablets — AB FDA listed —
atorvastatin calcium 80 mg 50090-7725-00 A-S 90 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 51655-0747-52 Northwind 30 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 51655-0881-30 Northwind 30 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 55154-4384-06 Cardinal 1 tablet — AB FDA listed —
Atorvastatin Calcium 80 mg 55154-7289-00 Cardinal 1 tablet — AB FDA listed —
Atorvastatin Calcium 80 mg 59651-0609-55 Aurobindo 15000 tablets — AB FDA listed —
Atorvastatin calcium 80 mg 60290-0042-01 Umedica 90 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 60505-2671-00 Apotex 10 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 63187-0656-30 Proficient 30 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 63187-0907-30 Proficient 30 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 63629-8472-01 Bryant 90 tablets — AB FDA listed —
Atorvastatin calcium 80 mg 67046-1593-03 Coupler 30 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 67046-1666-03 Coupler 30 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 68071-2018-03 NuCare 30 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 68071-2276-09 NuCare 90 tablets — — FDA listed —
Atorvastatin Calcium 80 mg 68071-2765-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 68071-3874-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 68071-3961-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin calcium 80 mg 68071-4962-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 69097-0911-05 Cipla 90 tablets — AB FDA listed —
Atorvastatin calcium 80 mg 70518-3304-00 REMEDYREPACK 30 tablets — AB Discontinued —
Atorvastatin calcium 80 mg 70518-3848-00 REMEDYREPACK 90 tablets — AB FDA listed —
Atorvastatin calcium 80 mg 70518-4473-00 REMEDYREPACK 90 tablets — AB FDA listed —
Atorvastatin calcium 80 mg 70756-0250-30 Lifestar 30 tablets — AB FDA listed —
atorvastatin calcium 80 mg 70771-1878-00 Zydus 1000 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 71205-0098-30 Proficient 30 tablets — AB FDA listed —
Atorvastatin calcium 80 mg 71205-0335-20 Proficient 20 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 71209-0093-04 Cadila 90 tablets — — FDA listed —
Atorvastatin calcium 80 mg 71335-1336-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 71335-2225-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 71335-2407-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 71335-2582-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin calcium 80 mg 71335-9646-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 71610-0036-15 Aphena 15 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 71610-0633-15 Aphena 15 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 71610-0746-15 Aphena 15 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 72162-1556-09 Bryant 90 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 72189-0537-30 Direct_Rx 30 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 76420-0948-00 Asclemed 1000 tablets — AB FDA listed —
Atorvastatin Calcium 80 mg 77771-0454-05 Radha 500 tablets — AB FDA listed —
atorvastatin calcium 80 mg 82137-0019-01 Lepu 90 tablets — — FDA listed —
Atorvastatin Calcium 80 mg 55154-0284-06 Cardinal 1 tablet — 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

🏛️
2018
On the market since
Dec 2018
📍
2026
Currently FDA-listed
8 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 67877-0514-90, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
20.5K
Units reimbursed last 4 qtrs
923.4K
Gross reimbursed last 4 qtrs
$240.4K
Avg / prescription
$11.73
Avg / unit
$0.2603
Latest quarter Q4 2025
1.2KRx
Medicaid pays / ea
$0.2603
gross reimbursed
vs
NADAC / ea
$0.0692
acquisition cost
=
Spread
+$0.1911
+276% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
52% FFS 48% MCO
Fee-for-service · 10,706 Rx Managed care · 9,782 Rx
State Medicaid map
Alaska: 3,804 units · 519 per 100k residents AK Maine: 2,865 units · 205 per 100k residents ME Washington: 18,255 units · 234 per 100k residents WA Idaho: 3,254 units · 166 per 100k residents ID Montana: 4,528 units · 400 per 100k residents MT North Dakota: 1,108 units · 142 per 100k residents ND Minnesota: 4,412 units · 76.9 per 100k residents MN Wisconsin: 12,126 units · 205 per 100k residents WI Michigan: 27,206 units · 271 per 100k residents MI New York: 173,121 units · 885 per 100k residents NY Vermont: 3,226 units · 499 per 100k residents VT New Hampshire: 1,867 units · 133 per 100k residents NH Oregon: 15,032 units · 355 per 100k residents OR Nevada: 5,691 units · 178 per 100k residents NV Wyoming: 480 units · 82.2 per 100k residents WY South Dakota: no data reported SD Iowa: 8,176 units · 255 per 100k residents IA Illinois: 24,056 units · 192 per 100k residents IL Indiana: 6,019 units · 87.7 per 100k residents IN Ohio: 48,393 units · 411 per 100k residents OH Pennsylvania: 46,057 units · 355 per 100k residents PA New Jersey: 19,119 units · 206 per 100k residents NJ Massachusetts: 16,645 units · 238 per 100k residents MA California: 132,740 units · 341 per 100k residents CA Utah: 614 units · 18.0 per 100k residents UT Colorado: 10,037 units · 171 per 100k residents CO Nebraska: 4,060 units · 205 per 100k residents NE Missouri: 23,148 units · 374 per 100k residents MO Kentucky: 33,131 units · 732 per 100k residents KY West Virginia: 24,316 units · 1,374 per 100k residents WV Virginia: 25,770 units · 296 per 100k residents VA Maryland: 32,560 units · 527 per 100k residents MD Connecticut: 12,800 units · 354 per 100k residents CT Rhode Island: 1,350 units · 123 per 100k residents RI Arizona: 1,628 units · 21.9 per 100k residents AZ New Mexico: 2,144 units · 101 per 100k residents NM Kansas: 3,164 units · 108 per 100k residents KS Arkansas: 13,655 units · 445 per 100k residents AR Tennessee: 19,406 units · 272 per 100k residents TN North Carolina: 18,304 units · 169 per 100k residents NC South Carolina: 420 units · 7.8 per 100k residents SC Delaware: 1,005 units · 97.5 per 100k residents DE Oklahoma: 7,995 units · 197 per 100k residents OK Louisiana: 10,274 units · 225 per 100k residents LA Mississippi: 2,610 units · 88.8 per 100k residents MS Alabama: 5,160 units · 101 per 100k residents AL Georgia: 13,524 units · 123 per 100k residents GA D.C.: 17,306 units · 2,549 per 100k residents DC Hawaii: no data reported HI Texas: 10,857 units · 35.6 per 100k residents TX Florida: 11,891 units · 52.6 per 100k residents FL
Units reimbursed · per 100k residents
7.82,549
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 D.C. 2,549 /100k
2 West Virginia 1,374 /100k
3 New York 885 /100k
4 Kentucky 732 /100k
5 Maryland 527 /100k
6 Alaska 519 /100k
7 Vermont 499 /100k
8 Arkansas 445 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
90 tablets this page67877-0514-90 20,488 Rx · $240,374
500 tablets67877-0514-05 3,695 Rx · $34,373
1000 tablets67877-0514-10 No Medicaid data
10 tablets67877-0514-38 No Medicaid data
Drug total (last 4 qtrs): 24,183 Rx · 1,092,503 units · $274,747 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Atorvastatin Calcium — 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. 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 Per unit Per pack Marketing startStatus
67877-0514-05 500 TABLET, FILM COATED in 1 BOTTLE (67877-514-05) $0.0692 / ea $34.62 2018-12-23 Active
67877-0514-10 1000 TABLET, FILM COATED in 1 BOTTLE (67877-514-10) $0.0692 / ea $69.18 2018-12-23 Active
67877-0514-38 10 BLISTER PACK in 1 CARTON (67877-514-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-514-33) — — 2018-12-23 Active
67877-0514-90 You're viewing this 90 TABLET, FILM COATED in 1 BOTTLE (67877-514-90) $0.0692 / ea $6.23 2018-12-23 Active

This pack effectively ties for the lowest per-ea cost of the 3 priced pack sizes ($0.0692 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 85% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 67877-0514-90?
NDC 67877-0514-90 is a 90-count package — 90 tablet, film coated in 1 bottle.
What is the difference between NDC 67877-0514-90 and NDC 67877-0514-05?
Both are Atorvastatin Calcium 80 mg Tablet, Film Coated — the drug itself is identical. NDC 67877-0514-90 is the 90-count package, while NDC 67877-0514-05 is the 500 tablets package.
What NDC number is used to bill for this package of Atorvastatin Calcium 80 mg Tablet, Film Coated?
Bill NDC 67877-0514-90 — the 11-digit billing format is 67877051490. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Atorvastatin calcium is indicated: To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.

Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia Atorvastatin calcium is an HMG-CoA reductase inhibitor (statin) indicated ( 1 ): To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.

MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein (LDL-C) in: Adults with primary hyperlipidemia.

Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia. As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.

Hypertriglyceridemia.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Take orally once daily with or without food ( 2.1 ). Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating atorvastatin calcium, and adjust dosage if necessary ( 2.1 ). Adults ( 2.2 ): Recommended starting dosage is 10 or 20 mg once daily; dosage range is 10 mg to 80 mg once daily.

Patients requiring LDL-C reduction >45% may start at 40 mg once daily. Pediatric Patients Aged 10 Years of Age and Older with HeFH: Recommended starting dosage is 10 mg once daily; dosage range is 10 to 20 mg once daily ( 2.3 ). Pediatric Patients Aged 10 Years of Age and Older with HoFH: Recommended starting dosage is 10 to 20 mg once daily; dosage range is 10 to 80 mg once daily ( 2.4 ).

See full prescribing information for atorvastatin calcium dosage modifications due to drug interactions ( 2.5 ).

2.1Important Dosage Information Take atorvastatin calcium tablets orally once daily at any time of the day, with or without food. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating atorvastatin calcium tablets, and adjust the dosage if necessary. If a dose is missed, advise patients not to take the missed dose and resume with the next scheduled dose.

2.2Recommended Dosage in Adult Patients The recommended starting dosage of atorvastatin calcium tablets is 10 mg to 20 mg once daily. The dosage range is 10 mg to 80 mg once daily. Patients who require reduction in LDL-C greater than 45% may be started at 40 mg once daily.

2.3Recommended Dosage in Pediatric Patients 10 Years of Age and Older with HeFH The recommended starting dosage of atorvastatin calcium tablets is 10 mg once daily. The dosage range is 10 mg to 20 mg once daily.

2.4Recommended Dosage in Pediatric Patients 10 Years of Age and Older with HoFH The recommended starting dosage of atorvastatin calcium tablets is 10 mg to 20 mg once daily. The dosage range is 10 mg to 80 mg once daily.

2.5Dosage Modifications Due to Drug Interactions Concomitant use of atorvastatin calcium tablets with the following drugs requires dosage modification of atorvastatin calcium tablets [see Warnings and Precautions ( 5.1 ) and Drug Interactions ( 7.1 )]. Anti-Viral Medications In patients taking saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or letermovir, do not exceed atorvastatin calcium tablets 20 mg once daily. In patients taking nelfinavir, do not exceed atorvastatin calcium tablets 40 mg once daily.

Select Azole Antifungals or Macrolide Antibiotics In patients taking clarithromycin or itraconazole, do not exceed atorvastatin calcium tablets 20 mg once daily. For additional recommendations regarding concomitant use of atorvastatin calcium tablets with other anti-viral medications, azole antifungals or macrolide antibiotics, see Drug Interactions ( 7.1 ).

💊 Dosage Forms and Strengths 95 words ▾

3 DOSAGE FORMS AND STRENGTHS Atorvastatin Calcium Tablets, USP: 10 mg of atorvastatin: white elliptical, film-coated tablets with "10" on one side and "ATS" on other side 20 mg of atorvastatin: white elliptical, film-coated tablets with "20" on one side and "ATS" on other side 40 mg of atorvastatin: white elliptical, film-coated tablets with "40" on one side and "ATS" on other side 80 mg of atorvastatin: white elliptical, film-coated tablets with "80" on one side and "ATS" on other side Tablets: 10 mg; 20 mg; 40 mg; 80 mg of atorvastatin ( 3 ).

⛔ Contraindications 68 words ▾

4 CONTRAINDICATIONS Acute liver failure or decompensated cirrhosis [see Warnings and Precautions ( 5.3 )] Hypersensitivity to atorvastatin or any excipients in atorvastatin calcium. Hypersensitivity reactions, including anaphylaxis, angioneurotic edema, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported [see Adverse Reactions ( 6.2 )]. Acute liver failure or decompensated cirrhosis ( 4) .

Hypersensitivity to atorvastatin or any excipient in atorvastatin calcium ( 4 ).

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher atorvastatin calcium dosage. Discontinue atorvastatin calcium if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue atorvastatin calcium in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis.

Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing atorvastatin calcium dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever ( 2.5 , 5.1 , 7.1 , 8.5 , 8.6 ). Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use.

Discontinue atorvastatin calcium if IMNM is suspected ( 5.2 ). Hepatic Dysfunction: Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred.

Consider testing liver enzymes before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue atorvastatin calcium ( 5.3 ).

5.1Myopathy and Rhabdomyolysis Atorvastatin calcium may cause myopathy (muscle pain, tenderness, or weakness associated with elevated creatine kinase [CK]) and rhabdomyolysis. Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis in patients treated with statins, including atorvastatin calcium. Risk Factors for Myopathy Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs (including other lipid-lowering therapies), and higher atorvastatin calcium dosage [see Drug Interactions ( 7.1 ) and Use in Specific Populations ( 8.5 , 8.6 )].

Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis Atorvastatin calcium exposure may be increased by drug interactions due to inhibition of cytochrome P450 enzyme 3A4 (CYP3A4) and/or transporters (e.g., breast cancer resistant protein [BCRP], organic anion-transporting polypeptide [OATP1B1/OATP1B3] and P-glycoprotein [P-gp]), resulting in an increased risk of myopathy and rhabdomyolysis. Concomitant use of cyclosporine, gemfibrozil, tipranavir plus ritonavir, or glecaprevir plus pibrentasvir with atorvastatin calcium is not recommended.

Atorvastatin calcium dosage modifications are recommended for patients taking certain anti-viral, azole antifungals, or macrolide antibiotic medications [see Dosage and Administration ( 2.5 )] . Cases of myopathy/rhabdomyolysis have been reported with atorvastatin co-administered with lipid modifying doses (>1 gram/day) of niacin, fibrates, colchicine, and ledipasvir plus sofosbuvir [see Adverse Reactions ( 6.1 )] . Consider if the benefit of use of these products outweighs the increased risk of myopathy and rhabdomyolysis [see Drug Interaction s ( 7.1 )] .

Concomitant intake of large quantities, more than 1.2 liters daily, of grapefruit juice is not recommended in patients taking atorvastatin calcium [see Drug Interactions ( 7.1 )]. Discontinue atorvastatin calcium if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected. Muscle symptoms and CK elevations may resolve if atorvastatin calcium is discontinued.

Temporarily discontinue atorvastatin calcium in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis (e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy). Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the atorvastatin ca…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions ( 5.1 )] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions ( 5.2 )] Hepatic Dysfunction [see Warnings and Precautions ( 5.3 )] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (incidence ≥ 5%) are nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection ( 6.1 ).

To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the atorvastatin calcium placebo-controlled clinical trial database of 16,066 patients (8,755 atorvastatin calcium vs. 7,311 placebo; age range 10 to 93 years, 39% female, 91% White, 3% Black or African American, 2% Asian, 4% other) with a median treatment duration of 53 weeks, the most common adverse reactions in patients treated with atorvastatin calcium that led to treatment discontinuation and occurred at a rate greater than placebo were: myalgia (0.7%), diarrhea (0.5%), nausea (0.4%), alanine aminotransferase increase (0.4%), and hepatic enzyme increase (0.4%).

Table 1 summarizes adverse reactions reported in ≥ 2% and at a rate greater than placebo in patients treated with atorvastatin calcium (n=8,755), from seventeen placebo-controlled trials. Table 1: Adverse Reactions Occurring in ≥ 2% in Patients Atorvastatin calcium -Treated with any Dose and Greater than Placebo Adverse Reaction % Placebo N=7,311 % 10 mg N=3,908 % 20 mg N=188 % 40 mg N=604 % 80 mg N=4,055 % Any dose N=8,755 Nasopharyngitis 8.2 12.9 5.3 7.0 4.2

8.3Arthralgia 6.5 8.9 11.7 10.6 4.3

6.9Diarrhea 6.3 7.3 6.4 14.1 5.2

6.8Pain in extremity 5.9 8.5 3.7 9.3 3.1

6.0Urinary tract infection 5.6 6.9 6.4 8.0 4.1

5.7Dyspepsia 4.3 5.9 3.2 6.0 3.3

4.7Nausea 3.5 3.7 3.7 7.1 3.8

4.0Musculoskeletal pain 3.6 5.2 3.2 5.1 2.3

3.8Muscle spasms 3.0 4.6 4.8 5.1 2.4

3.6Myalgia 3.1 3.6 5.9 8.4 2.7

3.5Insomnia 2.9 2.8 1.1 5.3 2.8

3.0Pharyngolaryngeal pain 2.1 3.9 1.6 2.8 0.7

2.3Other adverse reactions reported in placebo-controlled trials include: Body as a Whole : malaise, pyrexia Digestive System: abdominal discomfort, eructation, flatulence, hepatitis, cholestasis Musculoskeletal System : musculoskeletal pain, muscle fatigue, neck pain, joint swelling Metabolic and Nutritional System : transaminases increase, liver function test abnormal, blood alkaline phosphatase increase, creatine phosphokinase increase, hyperglycemia Nervous System : nightmare Respiratory System: epistaxis Skin and Appendages : urticaria Special Senses : vision blurred, tinnitus Urogenital System: white blood cells urine positive Elevations in Liver Enzyme Tests Persistent elevations in serum transaminases, defined as more than 3 times the ULN and occurring on 2 or more occasions, occurred in 0.7% of patients who received atorvastatin calcium in clinical trials.

The incidence of these abnormalities was 0.2%, 0.2%, 0.6%, and 2.3% for 10, 20, 40, and 80 mg, respectively. One patient in clinical trials developed jaundice. Increases in liver enzyme tests in other patients were not associated with jaundice or other clinical signs or symptoms.

Upon dose reduction, drug interruption, or discontinuation, transaminase levels returned to or near pretreatment levels without sequelae. Eighteen of 30 patients with persistent liver enzyme elevations continued treatment with a reduced dose of atorvastatin calcium. Treating to New Targets Study (TNT) In TNT , [see Clinical Studies (14.1)] 10,001 patients (age range 29 to 78 years, 19…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS See full prescribing information for details regarding concomitant use of atorvastatin calcium with other drugs or grapefruit juice that increase the risk of myopathy and rhabdomyolysis ( 2.5 , 7.1 ). Rifampin: May reduce atorvastatin plasma concentrations. Administer simultaneously with atorvastatin calcium ( 7.2 ).

Oral Contraceptives: May increase plasma levels of norethindrone and ethinyl estradiol; consider this effect when selecting an oral contraceptive ( 7.3 ). Digoxin: May increase digoxin plasma levels; monitor patients appropriately ( 7.3 ).

7.1Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with atorvastatin calcium Atorvastatin calcium is a substrate of CYP3A4 and transporters (e.g., OATP1B1/1B3, P-gp, or BCRP). Atorvastatin calcium plasma levels can be significantly increased with concomitant administration of inhibitors of CYP3A4 and transporters. Table 2 includes a list of drugs that may increase exposure to atorvastatin calcium and may increase the risk of myopathy and rhabdomyolysis when used concomitantly and instructions for preventing or managing them [see Warnings and Precautions (5.1) and Clinical Pharmacology ( 12.3 )].

Table 2: Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with atorvastatin calcium Cyclosporine or Gemfibrozil Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin calcium and cyclosporine, an inhibitor of CYP3A4 and OATP1B1 [see Clinical Pharmacology ( 12.3 )]. Gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine or gemfibrozil with atorvastatin calcium.

Intervention: Concomitant use of cyclosporine or gemfibrozil with atorvastatin calcium is not recommended. Anti-Viral Medications Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin calcium with many anti-viral medications, which are inhibitors of CYP3A4 and/or transporters (e.g., BCRP, OATP1B1/1B3, P-gp, MRP2, and/or OAT2) [see Clinical Pharmacology ( 12.3 )]. Cases of myopathy and rhabdomyolysis have been reported with concomitant use of ledipasvir plus sofosbuvir with atorvastatin calcium.

Intervention: Concomitant use of tipranavir plus ritonavir or glecaprevir plus pibrentasvir with atorvastatin calcium is not recommended. In patients taking lopinavir plus ritonavir, or simeprevir, consider the risk/benefit of concomitant use with atorvastatin. In patients taking saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or letermovir, do not exceed atorvastatin calcium 20 mg.

In patients taking nelfinavir, do not exceed atorvastatin calcium 40 mg [see Dosage and Administration ( 2.5 )]. Consider the risk/benefit of concomitant use of ledipasvir plus sofosbuvir with atorvastatin calcium. Monitor all patients for signs and symptoms of myopathy particularly during initiation of therapy and during upward dose titration of either drug.

Examples: Tipranavir plus ritonavir, glecaprevir plus pibrentasvir, lopinavir plus ritonavir, simeprevir, saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir, letermovir, nelfinavir, and ledipasvir plus sofosbuvir. Select Azole Antifungals or Macrolide Antibiotics Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin calcium with select azole antifungals or macrolide antibiotics, due to inhibition of CYP3A4 and/or transporters [see Clinical Pharmacology ( 12.3 )].

Intervention: In patients taking clarithromycin or itraconazole, do not exceed atorvastatin calcium 20 mg [see Dosage and Administration ( 2.5 )]. Consider the risk/benefit of concomitant use of other azole antifungals or macrolide antibiotics with a…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. ( 8.1 ). Lactation: Breastfeeding not recommended during treatment with atorvastatin calcium ( 8.2 ).

8.1Pregnancy Risk Summary Discontinue atorvastatin calcium when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Atorvastatin calcium decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, atorvastatin calcium may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology ( 12.1 )].

In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations.

Published data from prospective and retrospective observational cohort studies with atorvastatin calcium use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see Data). In animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered atorvastatin at doses that resulted in up to 30 and 20 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 80 mg, based on body surface area (mg/m 2 ).

In rats administered atorvastatin during gestation and lactation, decreased postnatal growth and development delay were observed at doses ≥ 6 times the MRHD (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Human Data A Medicaid cohort linkage study of 1,152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity score-based methods. The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus.

There were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. In the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births.

Animal Data Atorvastatin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 300 mg/kg/day and 100mg/kg/day, respectively. Atorvastatin was not teratogenic in rats at doses up to 300 mg/kg/day or in rabbits at doses up to 100 mg/kg/day. These doses resulted in multiples of about 30 times (rat) or 20 times (rabbit) the human exposure at the MRHD based on surface area (mg/m 2 ).

In rats, the maternally toxic dose of 300 mg/kg resulted in increased post-implantation loss and decreased fetal body weight. At the maternally toxic doses of 50 and 100 mg/kg/day in r…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Discontinue atorvastatin calcium when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Atorvastatin calcium decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, atorvastatin calcium may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology ( 12.1 )].

In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations.

Published data from prospective and retrospective observational cohort studies with atorvastatin calcium use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see Data). In animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered atorvastatin at doses that resulted in up to 30 and 20 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 80 mg, based on body surface area (mg/m 2 ).

In rats administered atorvastatin during gestation and lactation, decreased postnatal growth and development delay were observed at doses ≥ 6 times the MRHD (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Human Data A Medicaid cohort linkage study of 1,152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity score-based methods. The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus.

There were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. In the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births.

Animal Data Atorvastatin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 300 mg/kg/day and 100mg/kg/day, respectively. Atorvastatin was not teratogenic in rats at doses up to 300 mg/kg/day or in rabbits at doses up to 100 mg/kg/day. These doses resulted in multiples of about 30 times (rat) or 20 times (rabbit) the human exposure at the MRHD based on surface area (mg/m 2 ).

In rats, the maternally toxic dose of 300 mg/kg resulted in increased post-implantation loss and decreased fetal body weight. At the maternally toxic doses of 50 and 100 mg/kg/day in rabbits, there was increased post-implantation loss, and at 100 mg/kg/day fetal body weights were decreased. In a study in pregnant rats administered 20, 100, or 225…

🧒 Pediatric Use 188 words ▾

8.4Pediatric Use The safety and effectiveness of atorvastatin calcium as an adjunct to diet to reduce LDL-C have been established pediatric patients 10 years of age and older with HeFH. Use of atorvastatin calcium for this indication is based on a double-blind, placebo-controlled clinical trial in 187 pediatric patients 10 years of age and older with HeFH. In this limited controlled trial, there was no significant effect on growth or sexual maturation in the males or females or on menstrual cycle length in females.

The safety and effectiveness of atorvastatin calcium as an adjunct to other LDL-C-lowering therapies to reduce LDL-C have been established pediatric patients 10 years of age and older with HoFH. Use of atorvastatin calcium for this indication is based on a trial without a concurrent control group in 8 pediatric patients 10 years of age and older with HoFH [see Clinical Studies ( 14 )]. The safety and effectiveness of atorvastatin calcium have not been established in pediatric patients younger than 10 years of age with HeFH or HoFH, or in pediatric patients with other types of hyperlipidemia (other than HeFH or HoFH).

🧓 Geriatric Use 115 words ▾

8.5Geriatric Use Of the total number of atorvastatin calcium-treated patients in clinical trials, 15,813 (40%) were ≥65 years old and 2,800 (7%) were ≥75 years old. No overall differences in safety or effectiveness were observed between these patients and younger patients. Advanced age (≥65 years) is a risk factor for atorvastatin calcium-associated myopathy and rhabdomyolysis.

Dose selection for an elderly patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy. Monitor geriatric patients receiving atorvastatin calcium for the increased risk of myopathy [see Warnings and Precautions ( 5.1 ) and Clinical Pharmacology ( 12.3 )].

🆘 Overdosage 35 words ▾

10 OVERDOSAGE No specific antidotes for atorvastatin calcium are known. Contact Poison Control (1-800-222-1222) for latest recommendations. Due to extensive drug binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin calcium clearance.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Atorvastatin calcium is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3- methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. In animal models, atorvastatin calcium lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and by increasing the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL; atorvastatin calcium also reduces LDL production and the number of LDL particles.

12.2Pharmacodynamics Atorvastatin calcium, as well as some of its metabolites, are pharmacologically active in humans. The liver is the primary site of action and the principal site of cholesterol synthesis and LDL clearance. Drug dosage, rather than systemic drug concentration, correlates better with LDL-C reduction. Individualization of drug dosage should be based on therapeutic response [see Dosage and Administration (2) ].

12.3Pharmacokinetics Absorption Atorvastatin calcium is rapidly absorbed after oral administration; maximum plasma concentrations occur within 1 to 2 hours. Extent of absorption increases in proportion to atorvastatin calcium dose. The absolute bioavailability of atorvastatin (parent drug) is approximately 14% and the systemic availability of HMG-CoA reductase inhibitory activity is approximately 30%.

The low systemic availability is attributed to presystemic clearance in gastrointestinal mucosa and/or hepatic first-pass metabolism. Although food decreases the rate and extent of drug absorption by approximately 25% and 9%, respectively, as assessed by C max and AUC, LDL-C reduction is similar whether atorvastatin calcium is given with or without food. Plasma atorvastatin calcium concentrations are lower (approximately 30% for C max and AUC) following evening drug administration compared with morning.

However, LDL-C reduction is the same regardless of the time of day of drug administration. Distribution Mean volume of distribution of atorvastatin calcium is approximately 381 liters. Atorvastatin calcium is ≥98% bound to plasma proteins.

A blood/plasma ratio of approximately 0.25 indicates poor drug penetration into red blood cells. Elimination Metabolism Atorvastatin calcium is extensively metabolized to ortho- and parahydroxylated derivatives and various beta-oxidation products. In vitro inhibition of HMG-CoA reductase by ortho- and parahydroxylated metabolites is equivalent to that of atorvastatin calcium.

Approximately 70% of circulating inhibitory activity for HMG-CoA reductase is attributed to active metabolites. In vitro studies suggest the importance of atorvastatin calcium metabolism by cytochrome P450 3A4, consistent with increased plasma concentrations of atorvastatin calcium in humans following co-administration with erythromycin, a known inhibitor of this isozyme [see Drug Interactions (7.1) ]. In animals, the ortho-hydroxy metabolite undergoes further glucuronidation.

Excretion Atorvastatin calcium and its metabolites are eliminated primarily in bile following hepatic and/or extra-hepatic metabolism; however, the drug does not appear to undergo enterohepatic recirculation. Mean plasma elimination half-life of atorvastatin calcium in humans is approximately 14 hours, but the half-life of inhibitory activity for HMG-CoA reductase is 20 to 30 hours due to the contribution of active metabolites. Less than 2% of a dose of atorvastatin calcium is recovered in urine following oral administration.

Specific Populations Geriatric Plasma concentrations of atorvastatin calcium are higher (approximately 40% for C max and 30% for AUC) in healthy elderly subjects (age ≥65 years) than in young adults. Pediatric Apparent oral clearance of atorvastatin in pediatric subjects appeared similar to that of adults when scaled allometrically by body weight as the body weight was the only significant…

🧬 Mechanism of Action 83 words ▾

12.1Mechanism of Action Atorvastatin calcium is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3- methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. In animal models, atorvastatin calcium lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and by increasing the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL; atorvastatin calcium also reduces LDL production and the number of LDL particles.

📦 How Supplied / Storage and Handling 213 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Atorvastatin Calcium Tablets, USP are supplied as follows: Strength How Supplied NDC Tablet Description 10 mg of atorvastatin Bottle of 90 67877-511-90 White elliptical shaped, film coated tablets, debossed with '10' on one side and 'ATS' on other side Bottle of 500 67877-511-05 Bottle of 1000 67877-511-10 Bottle of 5000 67877-511-55 Carton of 100 (10 x 10 unit-dose) tablets 67877-511-38 20 mg of atorvastatin Bottle of 90 67877-512-90 White elliptical shaped, film coated tablets, debossed with '20' on one side and 'ATS' on other side Bottle of 500 67877-512-05 Bottle of 1000 67877-512-10 Bottle of 4000 67877-512-44 Carton of 100 (10 x 10 unit-dose) tablets 67877-512-38 40 mg of atorvastatin Bottle of 90 67877-513-90 White elliptical shaped, film coated tablets, debossed with '40' on one side and 'ATS' on other side Bottle of 500 67877-513-05 Bottle of 1000 67877-513-10 Bottle of 2000 67877-513-23 Carton of 100 (10 x 10 unit-dose) tablets 67877-513-38 80 mg of atorvastatin Bottle of 90 67877-514-90 White elliptical shaped, film coated tablets, debossed with '80' on one side and 'ATS' on other side Bottle of 500 67877-514-05 Bottle of 1000 67877-514-10 Carton of 100 (10 x 10 unit-dose) tablets 67877-514-38 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

📋 Description 150 words ▾

11 DESCRIPTION Atorvastatin calcium is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole- 1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C 33 H 34 FN 2 O 5 ) 2 Ca•3H 2 O and its molecular weight is 1209.42.

Its structural formula is: Atorvastatin calcium, USP is a white to off-white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain 10 mg, 20 mg, 40 mg or 80 mg of atorvastatin, USP and the following inactive ingredients: Calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80.

The coating material contains hypromellose, polyethylene glycol, talc, titanium dioxide. atorvastatin-st

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Myopathy and Rhabdomyolysis Advise patients that atorvastatin calcium may cause myopathy and rhabdomyolysis. Inform patients that the risk is also increased when taking certain types of medication or consuming large quantities of grapefruit juice and they should discuss all medication, both prescription and over the counter, with their healthcare provider.

Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7.1 )]. Hepatic Dysfunction Inform patients that atorvastatin calcium may cause liver enzyme elevations and possibly liver failure. Advise patients to promptly report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice [see Warnings and Precautions ( 5.3 )].

Increases in HbA1c and Fasting Serum Glucose Levels Inform patients that increases in HbA1c and fasting serum glucose levels may occur with atorvastatin calcium. Encourage patients to optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices [see Warnings and Precautions ( 5.4 )]. Pregnancy Advise pregnant patients and patients who can become pregnant of the potential risk to a fetus.

Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if atorvastatin calcium should be discontinued [see Use in Specific Populations ( 8.1 )]. Lactation Advise patients that breastfeeding is not recommended during treatment with atorvastatin calcium [see Use in Specific Populations ( 8.2 )]. Missed Doses If a dose is missed, advise patients not to take the missed dose and resume with the next scheduled dose.

For Patient Information, please visit: http://www.ascendlaboratories.com/pti/atorvastatintab.pdf Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA. Distributed by: Ascend Laboratories, LLC Bedminster, NJ 07921 Trademarks are the property of their respective owners. Revised: January 2025

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