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Atorvastatin Calcium 20 mg Tablet, 90-count — NDC 61919-258-90 (Billing 61919-0258-90)

by Direct_Rx · 90 TABLET in 1 BOTTLE

This is a package of 90 tablets of Atorvastatin Calcium 20 mg Tablet from Direct_Rx, no longer marketed, no longer in the FDA NDC Directory.

NDC 61919-0258-90
🏷️ FDA NDC (as labeled) 61919-258-90 billing pads the product segment with a zero
This package
Contains90-count Pack sizes2 compare ↓
Product page 61919-0258-30 Also comes in: 30 tablets 61919-258-30
Rx only Generic Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 14, 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

NDC database record

One package, one record: these facts belong to NDC 61919-258-90 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
61919 labeler · 258 product · 90 package
Billing quantity
90 EA per package
Barcode (UPC-A, from the NDC)
3 6191925890 7
FDA record last changed
Jul 14, 2026
⚠️
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 ↗
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 61919-258-90
Product NDC 61919-258
11-digit billing NDC 61919025890
NCPDP billing unit EA — each (per item)
Application # ANDA091650
SPL Set ID 33b2b42d-60b1-47df-9df9-9965e13ece9f
Mechanism of action HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2024)
Route ORAL
Dosage form TABLET
Substance ATORVASTATIN CALCIUM TRIHYDRATE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 61919-258-90 — 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 → 61919-0258-90. 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.

Clinical

📖 What it is MedlinePlus · NLM

Atorvastatin is used to reduce the risk of heart attack and stroke decrease the amount of cholesterol (a fat-like substance that can build up and clog blood vessels causing heart attacks or strokes or other health problems) Atorvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing how much cholesterol your body makes. This lowers the amount of cholesterol that can build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It lowers LDL cholesterol and triglycerides when used with diet. It also lowers the risk of heart attack and stroke in adults who have CHD or are at higher risk, including people w...
  • Take it by mouth once a day. Any time of day works, and you can take it with or without food. Pick a time you will remember. If you miss a dose, one label says to skip it and take...
  • Common ones include stuffy nose, joint or muscle aches, diarrhea, upset stomach, and trouble sleeping. Many people have few problems. If muscle pain is unexplained or comes with we...
  • Call for unexplained muscle pain, tenderness or weakness, especially with fever. Also call for yellow skin or eyes, or signs of a serious allergy like facial swelling or a blisteri...
📖 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.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 30 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
61919-0258-30 61919-258-30 Main listing 30 TABLET in 1 BOTTLE 2019-09-19 — Inactivated by FDA
61919-0258-90 You're viewing this 90 TABLET in 1 BOTTLE 2015-01-01 — Inactivated by FDA

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 90-count package — 90 tablet in 1 bottle.
How does this package differ from NDC 61919-0258-30?
Both are Atorvastatin Calcium 20 mg Tablet — the drug itself is identical. This page's package is the 90-count one, while NDC 61919-0258-30 is the 30 tablets package.
What NDC number is used to bill for this package of Atorvastatin Calcium 20 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Atorvastatin Calcium 20 mg 00093-5059-10 Teva 1000 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 00378-3951-05 Mylan 500 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 00480-3586-10 Teva 1000 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 00904-6291-06 Major 1 tablet $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 16571-0137-09 Rising 90 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 31722-0425-05 Camber 500 tablets $0.028 AB Availability likely —
Atorvastatin calcium 20 mg 33342-0316-10 Macleods 90 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 42385-0941-01 Laurus 100 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 42571-0173-10 Micro 1000 tablets $0.028 AB Discontinued —
Atorvastatin Calcium 20 mg 43598-0099-05 Dr. 500 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 43598-0831-05 Dr. 500 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 50228-0452-05 ScieGen 500 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 50268-0094-15 AvPAK 1 tablet $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 51079-0209-20 Mylan 1 tablet $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 55111-0122-05 Dr. 500 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 67877-0512-05 Ascend 500 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 68084-0098-01 American 1 tablet $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 70377-0078-11 Biocon 90 tablets $0.028 AB Availability likely —
atorvastatin calcium 20 mg 70710-1775-00 Zydus 1000 tablets $0.028 AB Availability likely —
Atorvastatin calcium 20 mg 70756-0248-12 Lifestar 1000 tablets $0.028 AB Availability likely —
Atorvastatin calcium 20 mg 72205-0023-05 Novadoz 500 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 72603-0283-01 NorthStar 90 tablets $0.028 AB Availability likely —
Atorvastatin calcium 20 mg 72603-0404-02 NorthStar 100 tablets $0.028 AB Availability likely —
Atorvastatin calcium 20 mg 75834-0256-01 NIVAGEN 1000 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 82009-0002-10 Quallent 1000 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 82009-0177-10 Quallent 1000 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 16714-0174-01 NORTHSTAR 90 tablets $0.029 AB Discontinued —
Atorvastatin Calcium 20 mg 16729-0045-15 Accord 90 tablets $0.041 AB FDA listed —
Atorvastatin Calcium 20 mg 69097-0945-05 Cipla 90 tablets $0.041 AB FDA listed —
Lipitor 20 mg 58151-0156-77 Viatris 90 tablets $19.073 AB Availability likely —
Atorvastatin Calcium 20 mg 00615-8007-05 NCS 15 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 42708-0004-30 QPharma, 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 42708-0013-30 QPharma, 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 42708-0141-30 QPharma, 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 43063-0496-30 PD-Rx 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 48433-0008-20 Safecor 1 tablet — AB FDA listed —
Atorvastatin Calcium 20 mg 50090-5181-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 50090-5182-00 A-S 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 50090-5634-00 A-S 30 tablets — — FDA listed —
Atorvastatin Calcium 20 mg 50090-6481-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 50090-6482-00 A-S 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 50090-7386-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 50090-7387-00 A-S 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 50090-7528-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 50090-7529-00 A-S 90 tablets — AB FDA listed —
atorvastatin calcium 20 mg 50090-7722-00 A-S 30 tablets — AB FDA listed —
atorvastatin calcium 20 mg 50090-7723-00 A-S 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 51655-0464-52 Northwind 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 51655-0920-26 Northwind 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 55154-6634-00 Cardinal 1 tablet — AB FDA listed —
Atorvastatin Calcium 20 mg 55154-7630-00 Cardinal 1 tablet — AB FDA listed —
Atorvastatin Calcium 20 mg 59651-0607-60 Aurobindo 60000 tablets — AB FDA listed —
Atorvastatin calcium 20 mg 60290-0040-01 Umedica 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 60505-2579-00 Apotex 10 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 60760-0883-90 St. 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 63187-0108-30 Proficient 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 63629-8470-01 Bryant 500 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 63629-8471-01 Bryant 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 67046-1403-03 Coupler 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 67046-1453-03 Coupler 30 tablets — AB FDA listed —
Atorvastatin calcium 20 mg 67046-1505-03 Coupler 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 67046-1526-03 Coupler 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 67046-1643-03 Coupler 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 68071-2824-09 NuCare 90 tablets — — FDA listed —
Atorvastatin calcium 20 mg 68071-2967-03 NuCare 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 68071-3580-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 68071-3659-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 68071-3714-03 NuCare 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 68071-3891-03 NuCare 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 68071-4840-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 68071-5168-03 NuCare 30 tablets — AB FDA listed —
Atorvastatin calcium 20 mg 68071-5292-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin calcium 20 mg 68788-4096-03 Preferred 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 68788-8625-01 Preferred 100 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 68788-8683-01 Preferred 100 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 68788-8693-01 Preferred 100 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 69097-0898-05 Cipla 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 70518-0186-00 REMEDYREPACK 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 70518-3037-00 REMEDYREPACK 30 tablets — AB Discontinued —
Atorvastatin calcium 20 mg 70518-3339-00 REMEDYREPACK 30 tablets — AB Discontinued —
Atorvastatin calcium 20 mg 70518-3783-00 REMEDYREPACK 30 tablets — AB Discontinued —
Atorvastatin calcium 20 mg 70518-4423-00 REMEDYREPACK 100 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 70518-4587-00 REMEDYREPACK 30 tablets — AB FDA listed —
atorvastatin calcium 20 mg 70771-1876-00 Zydus 1000 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 71205-0247-30 Proficient 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 71209-0091-04 Cadila 90 tablets — — FDA listed —
Atorvastatin Calcium 20 mg 71335-1010-01 Bryant 30 tablets — — FDA listed —
Atorvastatin Calcium 20 mg 71335-1051-01 Bryant 30 tablets — AB Discontinued —
Atorvastatin Calcium 20 mg 71335-1507-01 Bryant 30 tablets — AB Discontinued —
Atorvastatin Calcium 20 mg 71335-1929-01 Bryant 30 tablets — — FDA listed —
Atorvastatin calcium 20 mg 71335-2213-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 71335-2393-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 71335-2404-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin calcium 20 mg 71335-2799-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 71610-0022-45 Aphena 45 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 71610-0744-15 Aphena 15 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 72162-1555-05 Bryant 500 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 72162-1712-02 Bryant 9 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 72189-0291-90 DirectRX 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 72189-0587-30 Direct_Rx 30 tablets — AB FDA listed —
Atorvastatin calcium 20 mg 72789-0084-30 PD-Rx 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 76420-0945-00 Asclemed 1000 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 77771-0452-05 Radha 500 tablets — AB FDA listed —
atorvastatin calcium 20 mg 82137-0017-01 Lepu 90 tablets — — FDA listed —
Atorvastatin Calcium 20 mg 82804-0054-30 Proficient 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 82804-0161-30 Proficient 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mgthis 61919-0258-90 Direct_Rx 90 tablets — AB Discontinued —
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

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

What it looks like

Color white
ShapeCapsule
ImprintRDY;122
Size12 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 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII 905HNO1SIH
    A synthetic polymer made from methacrylate compounds that forms a film coating on tablets or capsules. It helps control how quickly the medicine dissolves and releases its active ingredient in the digestive system.
  • UNII 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
  • 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 ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • 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 Y4S76JWI15
    Methyl alcohol, also called methanol, is a simple organic solvent. It helps dissolve and carry active ingredients in liquid medicines, and helps the product mix evenly.
  • UNII 588X2YUY0A
    Methylene chloride is a volatile organic solvent used in pharmaceutical manufacturing to dissolve and process active ingredients and other substances. It evaporates during production, helping create tablets, capsules, or coatings with uniform quality.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 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.

14 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.

Manufacturer & labeler

LabelerDirect_Rx
Application holderDR REDDYS LABORATORIES LTD
FDA applicationANDA091650 (ANDA)
Labeler code61919
Product typeHuman Prescription Drug
Portfolio355 products on file

More NDCs from Direct_Rx labeler code 61919

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🆘 Overdosage 🧬 Clinical Pharmacology 📋 Description 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

INDICATIONS & USAGE SECTION Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.

1.1Prevention of Cardiovascular Disease In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to: Reduce the risk of myocardial infarction Reduce the risk of stroke Reduce the risk for revascularization procedures and angina In patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, atorvastatin calcium tablets are indicated to: Reduce the risk of myocardial infarction Reduce the risk of stroke In patients with clinically evident coronary heart disease, atorvastatin calcium tablets are indicated to: Reduce the risk of non-fatal myocardial infarction Reduce the risk of fatal and non-fatal stroke Reduce the risk for revascularization procedures Reduce the risk of hospitalization for CHF Reduce the risk of angina

1.2Hyperlipidemia Atorvastatin calcium tablets are indicated: As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb); As an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV); For the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet; To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable; As an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: a.

LDL-C remains ≥ 190 mg/dL or b. LDL-C remains ≥ 160 mg/dL and: there is a positive family history of premature cardiovascular disease or two or more other CVD risk factors are present in the pediatric patient

1.3Limitations of Use Atorvastatin calcium tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE & ADMINISTRATION SECTION

2.1Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb) The recommended starting dose of atorvastatin calcium tablets is 10 or 20 mg once daily. Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. The dosage range of atorvastatin calcium tablets is 10 to 80 mg once daily.

Atorvastatin calcium tablets can be administered as a single dose at any time of the day, with or without food. The starting dose and maintenance doses of atorvastatin calcium tablets should be individualized according to patient characteristics such as goal of therapy and response (see current NCEP Guidelines). After initiation and/or upon titration of atorvastatin calcium tablets, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.

2.2Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age) The recommended starting dose of atorvastatin calcium tablets is 10 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [see current NCEP Pediatric Panel Guidelines, Clinical Pharmacology (12) , and Indications and Usage ( 1.2) ]. Adjustments should be made at intervals of 4 weeks or more.

2.3Homozygous Familial Hypercholesterolemia The dosage of atorvastatin calcium tablets in patients with homozygous FH is 10 to 80 mg daily. Atorvastatin calcium tablets should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

2.4Concomitant Lipid-Lowering Therapy Atorvastatin calcium tablets may be used with bile acid resins. The combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be used with caution [see Warnings and Precautions, Skeletal Muscle (5.1) , Drug Interactions (7) ].

2.5Dosage in Patients with Renal Impairment Renal disease does not affect the plasma concentrations nor LDL-C reduction of atorvastatin calcium tablets; thus, dosage adjustment in patients with renal dysfunction is not necessary [see Warnings and Precautions, Skeletal Muscle (5.1) , Clinical Pharmacology, Pharmacokinetics (12.3) ].

2.6Dosage in Patients Taking Cyclosporine, Clarithromycin, Itraconazole, or Certain Protease Inhibitors In patients taking cyclosporine or the HIV protease inhibitors (tipranavir plus ritonavir) or the hepatitis C protease inhibitor (telaprevir), therapy with atorvastatin calcium tablets should be avoided. In patients with HIV taking lopinavir plus ritonavir, caution should be used when prescribing atorvastatin calcium tablets and the lowest dose necessary employed. In patients taking clarithromycin, itraconazole, or in patients with HIV taking a combination of saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, therapy with atorvastatin calcium tablets should be limited to 20 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin calcium is employed.

In patients taking the HIV protease inhibitor nelfinavir or the hepatitis C protease inhibitor boceprevir, therapy with atorvastatin calcium tablets should be limited to 40 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin calcium tablets is employed [see Warnings and Precautions, Skeletal Muscle (5.1) , Drug Interactions (7) ].

💊 Dosage Forms and Strengths 82 words ▾

DOSAGE FORMS & STRENGTHS SECTION Atorvastatin calcium tablets of 10 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘121’on other side. Atorvastatin calcium tablets of 20 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘122’ on other side. Atorvastatin calcium tablets of 40 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘123’ on other side.

⛔ Contraindications ~1 min read ▾

CONTRAINDICATIONS SECTION

4.1Active Liver Disease which may include Unexplained Persistent Elevations of Hepatic Transaminase Levels

4.2 Hypersensitivity to any component of this medication

4.3Pregnancy Women who are pregnant or may become pregnant. Atorvastatin calcium may cause fetal harm when administered to a pregnant woman. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development.

Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. There are no adequate and well-controlled studies of atorvastatin calcium use during pregnancy; however in rare reports, congenital anomalies were observed following intrauterine exposure to statins. In rat and rabbit animal reproduction studies, atorvastatin revealed no evidence of teratogenicity.

ATORVASTATIN CALCIUM SHOULD BE ADMINISTERED TO WOMEN OF CHILDBEARING AGE ONLY WHEN SUCH PATIENTS ARE HIGHLY UNLIKELY TO CONCEIVE AND HAVE BEEN INFORMED OF THE POTENTIAL HAZARDS. If the patient becomes pregnant while taking this drug, atorvastatin calcium should be discontinued immediately and the patient apprised of the potential hazard to the fetus [see Use in Specific Populations (8.1 ) ].

4.4Nursing mothers It is not known whether atorvastatin is excreted into human milk; however a small amount of another drug in this class does pass into breast milk. Because statins have the potential for serious adverse reactions in nursing infants, women who require atorvastatin calcium treatment should not breastfeed their infants [see Use in Specific Populations (8.3) ].

⚠️ Warnings and Cautions ~2 min read ▾

WARNINGS AND PRECAUTIONS SECTION

5.1Skeletal Muscle Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with atorvastatin calciumand with other drugs in this class. A history of renal impairment may be a risk factor for the development of rhabdomyolysis. Such patients merit closer monitoring for skeletal muscle effects.

Atorvastatin, like other statins, occasionally causes myopathy, defined as muscle aches or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values >10 times ULN. The concomitant use of higher doses of atorvastatin with certain drugs such as cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, and HIV protease inhibitors) increases the risk of myopathy/rhabdomyolysis. There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use.

IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents. Myopathy should be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation of CPK. Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing atorvastatin.

Atorvastatin calcium therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. The risk of myopathy during treatment with drugs in this class is increased with concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, clarithromycin, the hepatitis C protease inhibitor telaprevir, combinations of HIV protease inhibitors, including saquinavir plus ritonavir, lopinavir plus ritonavir, tipranavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, and fosamprenavir plus ritonavir, niacin, or azole antifungals.

Physicians considering combined therapy with atorvastatin calcium and fibric acid derivatives, erythromycin, clarithromycin, a combination of saquinavir plus ritonavir, lopinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, azole antifungals, or lipid-modifying doses of niacin should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs or symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and during any periods of upward dosage titration of either drug.

Lower starting and maintenance doses of atorvastatin should be considered when taken concomitantly with the aforementioned drugs (see Drug Interactions (7) ). Periodic creatine phosphokinase (CPK) determinations may be considered in such situations, but there is no assurance that such monitoring will prevent the occurrence of severe myopathy. Prescribing recommendations for interacting agents are summarized in Table 1 [see also Dosage and Administration (2.6) , Drug Interactions (7) , Clinical Pharmacology (12.3) ].

Table 1. Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis Interacting Agents Prescribing Recommendations Cyclosporine, HIV protease inhibitors (tipranavir plus ritonavir), hepatitis C protease inhibitor (telaprevir) Avoid atorvastatin HIV protease inhibitor (lopinavir plus ritonavir) Use with caution and lowest dose necessary Clarithromycin, itraconazole, HIV protease inhibitors (saquinavir plus ritonavir*, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir) Do not exceed 20 mg atorvastatin daily HIV protease inhibitor (nelfinavir) Hepatitis C protease inhibitor (boceprevir) Do not exceed 40 mg atorvastatin daily *Use with caution and with the lowest dose necessary (12.3) Cases of myopathy, i… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS SECTION The following serious adverse reactions are discussed in greater detail in other sections of the label: Rhabdomyolysis and myopathy [see Warnings and Precautions (5.1) ] Liver enzyme abnormalities [see Warnings and Precautions (5.2) ]

6.1Clinical Trial Adverse Experiences Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In the atorvastatin calcium placebo-controlled clinical trial database of 16,066 patients (8755 atorvastatin calcium vs. 7311 placebo; age range 10 to 93 years, 39% women, 91% Caucasians, 3% Blacks, 2% Asians, 4% other) with a median treatment duration of 53 weeks, 9.7% of patients on atorvastatin calcium and 9.5% of the patients on placebo discontinued due to adverse reactions regardless of causality.

The five 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%). The most commonly reported adverse reactions (incidence ≥ 2% and greater than placebo) regardless of causality, in patients treated with atorvastatin calcium in placebo controlled trials (n=8755) were: nasopharyngitis (8.3%), arthralgia (6.9%), diarrhea (6.8%), pain in extremity (6%), and urinary tract infection (5.7%).

Table 2 summarizes the frequency of clinical adverse reactions, regardless of causality, reported in ≥ 2% and at a rate greater than placebo in patients treated with atorvastatin calcium (n=8755), from seventeen placebo-controlled trials. Table 2. Clinical adverse reactions occurring in ≥ 2% in patients treated with any dose of atorvastatin calcium and at an incidence greater than placebo regardless of causality (% of patients).

Adverse Reaction* Any dose N=8755 10 mg N=3908 20 mg N=188 40 mg N=604 80 mg N=4055 Placebo N=7311 Nasopharyngitis 8.3 12.9 5.3 7 4.2

8.2Arthralgia 6.9 8.9 11.7 10.6 4.3

6.5Diarrhea 6.8 7.3 6.4 14.1 5.2

6.3Pain in extremity 6 8.5 3.7 9.3 3.1

5.9Urinary tractinfection 5.7 6.9 6.4 8 4.1

5.6Dyspepsia 4.7 5.9 3.2 6 3.3

4.3Nausea 4 3.7 3.7 7.1 3.8

3.5Musculoskeletal pain 3.8 5.2 3.2 5.1 2.3

3.6Muscle Spasms 3.6 4.6 4.8 5.1 2.4 3 Myalgia 3.5 3.6 5.9 8.4 2.7

3.1Insomnia 3 2.8 1.1 5.3 2.8

2.9Pharyngolaryngeal pain 2.3 3.9 1.6 2.8 0.7 2.1 * Adverse Reaction ≥ 2% in any dose greater than placebo Other adverse reactions reported in placebo-controlled studies 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.

Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) In ASCOT [see Clinical Studies (14.1) ] involving 10,305 participants (age range 40 to 80 years, 19% women; 94.6% Caucasians, 2.6% Africans, 1.5% South Asians, 1.3% mixed/other) treated with atorvastatin calcium 10 mg daily (n=5,168) or placebo (n=5,137), the safety and tolerability profile of the group treated with atorvastatin calcium was comparable to that of the group treated with placebo during a median of 3.3 years of follow-up. Collaborative Atorvastatin Diabetes Study (CARDS) In CARDS [see Clinical Studies (14.1) ] involving 2,838 subjects (age range 39 to 77 years, 32% women; 94.3% Caucasians, 2.4% South Asians, 2.3% Afro-Caribbean, 1% other) with ty… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

DRUG INTERACTIONS SECTION The risk of myopathy during treatment with statins is increased with concurrent administration of fibric acid derivatives, lipid-modifying doses of niacin, cyclosporine, or strong CYP 3A4 inhibitors (e.g., clarithromycin, HIV protease inhibitors, and itraconazole) [see Warnings and Precautions, Skeletal Muscle (5.1) and Clinical Pharmacology (12.3) ].

7.1Strong Inhibitors of CYP 3A4: Atorvastatin calcium is metabolized by cytochrome P450 3A4. Concomitant administration of atorvastatin calcium with strong inhibitors of CYP 3A4 can lead to increases in plasma concentrations of atorvastatin. The extent of interaction and potentiation of effects depend on the variability of effect on CYP 3A4.

Clarithromycin:Atorvastatin AUC was significantly increased with concomitant administration of atorvastatin calcium 80 mg with clarithromycin (500 mg twice daily) compared to that of atorvastatin calcium alone [see Clinical Pharmacology (12.3) ]. Therefore, in patients taking clarithromycin, caution should be used when the atorvastatin calcium dose exceeds 20 mg [see Warnings and Precautions, Skeletal Muscle (5.1) and Dosage and Administration (2.6) ]. Combination of Protease Inhibitors: Atorvastatin AUC was significantly increased with concomitant administration of atorvastatin calcium with several combinations of HIV protease inhibitors, as well as with the hepatitis C protease inhibitor telaprevir, compared to that of atorvastatin calcium alone [see Clinical Pharmacology (12.3) ].

Therefore, in patients taking the HIV protease inhibitor tipranavir plus ritonavir, or the hepatitis C protease inhibitor telaprevir, concomitant use of atorvastatin calcium should be avoided. In patients taking the HIV protease inhibitor lopinavir plus ritonavir, caution should be used when prescribing atorvastatin calcium and the lowest dose necessary should be used. In patients taking the HIV protease inhibitors saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, the dose of atorvastatin calcium should not exceed 20 mg and should be used with caution [see Warnings and Precautions, Skeletal Muscle (5.1) and Dosage and Administration (2.6) ].

In patients taking the HIV protease inhibitor nelfinavir or the hepatitis C protease inhibitor boceprevir, the dose of atorvastatin calcium should not exceed 40 mg andclose clinicalmonitoring is recommended. Itraconazole:Atorvastatin AUC was significantly increased with concomitant administration of atorvastatin calcium 40 mg and itraconazole 200 mg [see Clinical Pharmacology ( 12.3) ]. Therefore, in patients taking itraconazole, caution should be used when the atorvastatin calcium dose exceeds 20 mg [see Warnings and Precautions, Skeletal Muscle (5.1) and Dosage and Administration (2.6) ].

7.2Grapefruit Juice Contains one or more components that inhibit CYP 3A4 and can increase plasma concentrations of atorvastatin, especially with excessive grapefruit juice consumption (>1.2 liters per day).

7.3Cyclosporine Atorvastatin and atorvastatin-metabolites are substrates of the OATP1B1 transporter. Inhibitors of the OATP1B1 (e.g., cyclosporine) can increase the bioavailability of atorvastatin. Atorvastatin AUC was significantly increased with concomitant administration of atorvastatin calcium 10 mg and cyclosporine 5.2 mg/kg/day compared to that of atorvastatin calcium alone [see Clinical Pharmacology (12.3) ].

The co-administration of atorvastatin calcium with cyclosporine should be avoided [see Warnings and Precautions, Skeletal Muscle (5.1) ].

7.4Gemfibrozil Due to an increased risk of myopathy/rhabdomyolysis when HMG-CoA reductase inhibitors are co-administered with gemfibrozil, concomitant administration of atorvastatin calcium with gemfibrozil should be avoided [see Warnings and Precautions (5.1) ].

7.5Other Fibrates Because it is known that the risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased with concurrent admi… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

USE IN SPECIFIC POPULATIONS SECTION

8.1Pregnancy Pregnancy Category X Atorvastatin calcium is contraindicated in women who are or may become pregnant. Serum cholesterol and triglycerides increase during normal pregnancy. Lipid lowering drugs offer no benefit during pregnancy because cholesterol and cholesterol derivatives are needed for normal fetal development.

Atherosclerosis is a chronic process, and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primary hypercholesterolemia therapy. There are no adequate and well-controlled studies of atorvastatin use during pregnancy. There have been rare reports of congenital anomalies following intrauterine exposure to statins.

In a review of about 100 prospectively followed pregnancies in women exposed to other statins, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed the rate expected in the general population. However, this study was only able to exclude a three-to-four-fold increased risk of congenital anomalies over background incidence. In 89% of these cases, drug treatment started before pregnancy and stopped during the first trimester when pregnancy was identified.

Atorvastatin crosses the rat placenta and reaches a level in fetal liver equivalent to that of maternal plasma. 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 based on surface area (mg/m2) [see Contraindications, Pregnancy (4.3) ].

In a study in rats given 20, 100, or 225 mg/kg/day, from gestation day 7 through to lactation day 21 (weaning), there was decreased pup survival at birth, neonate, weaning, and maturity in pups of mothers dosed with 225 mg/kg/day. Body weight was decreased on days 4 and 21 in pups of mothers dosed at 100 mg/kg/day; pup body weight was decreased at birth and at days 4, 21, and 91 at 225 mg/kg/day. Pup development was delayed (rotorod performance at 100 mg/kg/day and acoustic startle at 225 mg/kg/day; pinnae detachment and eye-opening at 225 mg/kg/day).

These doses correspond to 6 times (100 mg/kg) and 22 times (225 mg/kg) the human AUC at 80 mg/day. Statins may cause fetal harm when administered to a pregnant woman. Atorvastatin calcium should be administered to women of childbearing potential only when such patients are highly unlikely to conceive and have been informed of the potential hazards.

If the woman becomes pregnant while taking atorvastatin calcium, it should be discontinued immediately and the patient advised again as to the potential hazards to the fetus and the lack of known clinical benefit with continued use during pregnancy.

8.3Nursing Mothers It is not known whether atorvastatin is excreted in human milk, but a small amount of another drug in this class does pass into breast milk. Nursing rat pups had plasma and liver drug levels of 50% and 40%, respectively, of that in their mother’s milk. Animal breast milk drug levels may not accurately reflect human breast milk levels.

Because another drug in this class passes into human milk and because statins have a potential to cause serious adverse reactions in nursing infants, women requiring atorvastatin calcium treatment should be advised not to nurse their infants [see Contraindications (4) ].

8.4Pediatric Use Safety and effectiveness in patients 10 to 17 years of age with heterozygous familial hypercholesterolemia have been evaluated in a controlled clinical trial of 6 months’ duration in adolescent boys and postmenarchal girls. Patients treated with atorvastatin calcium had an adverse experience profile generally similar to that of patients treated with placebo. The most common adverse experiences observed in both groups, regardless of causality assessment, were infections.

Doses greater than 20 mg have not been studied in this patient populati… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 47 words ▾

OVERDOSAGE SECTION There is no specific treatment for atorvastatin calcium overdosage. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Due to extensive drug binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin calcium clearance.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY SECTION

12.1Mechanism of Action Atorvastatin calcium is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. Cholesterol and triglycerides circulate in the bloodstream as part of lipoprotein complexes. With ultracentrifugation, these complexes separate into HDL (high-density lipoprotein), IDL (intermediate-density lipoprotein), LDL (low-density lipoprotein), and VLDL (very-low-density lipoprotein) fractions.

Triglycerides (TG) and cholesterol in the liver are incorporated into VLDL and released into the plasma for delivery to peripheral tissues. LDL is formed from VLDL and is catabolized primarily through the high-affinity LDL receptor. Clinical and pathologic studies show that elevated plasma levels of total cholesterol (total-C), LDL-cholesterol (LDL-C), and apolipoprotein B (apo B) promote human atherosclerosis and are risk factors for developing cardiovascular disease, while increased levels of HDL-C are associated with a decreased cardiovascular risk.

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. Atorvastatin calcium reduces LDL-C in some patients with homozygous familial hypercholesterolemia (FH), a population that rarely responds to other lipid-lowering medication(s).

A variety of clinical studies have demonstrated that elevated levels of total-C, LDL-C, and apo B (a membrane complex for LDL-C) promote human atherosclerosis. Similarly, decreased levels of HDL-C (and its transport complex, apo A) are associated with the development of atherosclerosis. Epidemiologic investigations have established that cardiovascular morbidity and mortality vary directly with the level of total-C and LDL-C, and inversely with the level of HDL-C.

Atorvastatin calcium reduces total-C, LDL-C, and apo B in patients with homozygous and heterozygous FH, nonfamilial forms of hypercholesterolemia, and mixed dyslipidemia. Atorvastatin calcium also reduces VLDL-C and TG and produces variable increases in HDL-C and apolipoprotein A-1. Atorvastatin calcium reduces total-C, LDL-C, VLDL-C, apo B, TG, and non-HDL-C, and increases HDL-C in patients with isolated hypertriglyceridemia.

Atorvastatin calcium reduces intermediate density lipoprotein cholesterol (IDL-C) in patients with dysbetalipoproteinemia. Like LDL, cholesterol-enriched triglyceride-rich lipoproteins, including VLDL, intermediate density lipoprotein (IDL), and remnants, can also promote atherosclerosis. Elevated plasma triglycerides are frequently found in a triad with low HDL-C levels and small LDL particles, as well as in association with non-lipid metabolic risk factors for coronary heart disease.

As such, total plasma TG has not consistently been shown to be an independent risk factor for CHD. Furthermore, the independent effect of raising HDL or lowering TG on the risk of coronary and cardiovascular morbidity and mortality has not been determined.

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 bioava… [Excerpted — this section continues on DailyMed.]

📋 Description 173 words ▾

DESCRIPTION SECTION Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.

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). The molecular formula of atorvastatin calcium is C66H68CaF2N4O10and its molecular weight is 1155.36. Its structural formula is: structure Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter.

Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets for oral administration contain 10, 20 and 40 mg atorvastatin and the following inactive ingredients: Basic butylated methacrylate copolymer, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, methanol, microcrystalline cellulose, sodium bicarbonate and sodium lauryl sulphate.

The tablet coating contains isopropyl alcohol, methylene chloride and coloring agent opadry OY-58900 white contains polyethylene glycol, titanium dioxide and hypromellose.

🔬 Clinical Studies ~3 min read ▾

CLINICAL STUDIES SECTION

14.1Prevention of Cardiovascular Disease In the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT), the effect of atorvastatin calcium on fatal and non-fatal coronary heart disease was assessed in 10,305 hypertensive patients 40 to 80 years of age (mean of 63 years), without a previous myocardial infarction and with TC levels ≤251 mg/dL (6.5 mmol/L). Additionally, all patients had at least 3 of the following cardiovascular risk factors: male gender (81.1%), age >55 years (84.5%), smoking (33.2%), diabetes (24.3%), history of CHD in a first-degree relative (26%), TC:HDL >6 (14.3%), peripheral vascular disease (5.1%), left ventricular hypertrophy (14.4%), prior cerebrovascular event (9.8%), specific ECG abnormality (14.3%), proteinuria/albuminuria (62.4%).

In this double-blind, placebo-controlled study, patients were treated with anti-hypertensive therapy (Goal BP <140/90 mm Hg for non-diabetic patients; <130/80 mm Hg for diabetic patients) and allocated to either atorvastatin calcium 10 mg daily (n=5168) or placebo (n=5137), using a covariate adaptive method which took into account the distribution of nine baseline characteristics of patients already enrolled and minimized the imbalance of those characteristics across the groups. Patients were followed for a median duration of 3.3 years.

The effect of 10 mg/day of atorvastatin calcium on lipid levels was similar to that seen in previous clinical trials. Atorvastatin calcium significantly reduced the rate of coronary events [either fatal coronary heart disease (46 events in the placebo group vs. 40 events in the atorvastatin calcium group) or non-fatal MI (108 events in the placebo group vs.

60 events in the atorvastatin calcium group)] with a relative risk reduction of 36% [(based on incidences of 1.9% for atorvastatin calcium vs. 3% for placebo), p=0.0005 (see Figure 1)]. The risk reduction was consistent regardless of age, smoking status, obesity, or presence of renal dysfunction.

The effect of atorvastatin calcium was seen regardless of baseline LDL levels. Due to the small number of events, results for women were inconclusive. Figure 1: Effect of Atorvastatin Calcium 10 mg/day on Cumulative Incidence of Non-Fatal Myocardial Infarction or Coronary Heart Disease Death (in ASCOT-LLA) Atorvastatin calcium also significantly decreased the relative risk for revascularization procedures by 42%.

Although the reduction of fatal and non-fatal strokes did not reach a pre-defined significance level (p=0.01), a favorable trend was observed with a 26% relative risk reduction (incidences of 1.7% for atorvastatin calcium and 2.3% for placebo). There was no significant difference between the treatment groups for death due to cardiovascular causes (p=0.51) or noncardiovascular causes (p=0.17). In the Collaborative Atorvastatin Diabetes Study (CARDS), the effect of atorvastatin calcium on cardiovascular disease (CVD) endpoints was assessed in 2838 subjects (94% white, 68% male), ages 40 to 75 with type 2 diabetes based on WHO criteria, without prior history of cardiovascular disease and with LDL ≤ 160 mg/dL and TG ≤ 600 mg/dL.

In addition to diabetes, subjects had 1 or more of the following risk factors: current smoking (23%), hypertension (80%), retinopathy (30%), or microalbuminuria (9%) or macroalbuminuria (3%). No subjects on hemodialysis were enrolled in the study. In this multicenter, placebo-controlled, double-blind clinical trial, subjects were randomly allocated to either atorvastatin calcium 10 mg daily (1429) or placebo (1411) in a 1:1 ratio and were followed for a median duration of 3.9 years.

The primary endpoint was the occurrence of any of the major cardiovascular events: myocardial infarction, acute CHD death, unstable angina, coronary revascularization, or stroke. The primary analysis was the time to first occurrence of the primary endpoint. Baseline characteristics of subjects were: mean age of 62 years, mean HbA1c 7.7%; median LDL-C 120 mg/dL; media… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

NONCLINICAL TOXICOLOGY SECTION

13.1Carcinogenesis, Mutagenesis, Impairment Of Fertility In a 2-year carcinogenicity study in rats at dose levels of 10, 30, and 100 mg/kg/day, 2 rare tumors were found in muscle in high-dose females: in one, there was a rhabdomyosarcoma and, in another, there was a fibrosarcoma. This dose represents a plasma AUC (0 to 24) value of approximately 16 times the mean human plasma drug exposure after an 80 mg oral dose. A 2-year carcinogenicity study in mice given 100, 200, or 400 mg/kg/day resulted in a significant increase in liver adenomas in high-dose males and liver carcinomas in high-dose females.

These findings occurred at plasma AUC (0 to 24) values of approximately 6 times the mean human plasma drug exposure after an 80 mg oral dose. In vitro, atorvastatin was not mutagenic or clastogenic in the following tests with and without metabolic activation: the Ames test with Salmonella typhimurium and Escherichia coli, the HGPRT forward mutation assay in Chinese hamster lung cells, and the chromosomal aberration assay in Chinese hamster lung cells. Atorvastatin was negative in the in vivo mouse micronucleus test.

Studies in rats performed at doses up to 175 mg/kg (15 times the human exposure) produced no changes in fertility. There was aplasia and aspermia in the epididymis of 2 of 10 rats treated with 100 mg/kg/day of atorvastatin for 3 months (16 times the human AUC at the 80 mg dose); testis weights were significantly lower at 30 and 100 mg/kg and epididymal weight was lower at 100 mg/kg. Male rats given 100 mg/kg/day for 11 weeks prior to mating had decreased sperm motility, spermatid head concentration, and increased abnormal sperm.

Atorvastatin caused no adverse effects on semen parameters, or reproductive organ histopathology in dogs given doses of 10, 40, or 120 mg/kg for two years.

📄 Package Label / Principal Display Panel 7 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL image description

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

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.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 30 tablets (61919-0258-30). 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?
Direct_Rx 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.
← 61919-0255-90 · Direct_Rx 61919-0261-15 · Direct_Rx →
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.