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Rosuvastatin Calcium 10 mg Tablet, Coated

by Major Pharmaceuticals · 100 BLISTER PACK in 1 CARTON (0904-6779-61) / 1 TABLET, COATED in 1 BLISTER PACK
NDC 00904-6779-61
🏷️ FDA NDC (as labeled) 0904-6779-61 billing pads the labeler segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Mar 13, 2024 · 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

⚠️
Other active recalls for Rosuvastatin 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 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0339-2025
Class II · Mar 23, 2023 — cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. (Preferred Pharmaceuticals, Inc.) · FDA recall D-0519-2023
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. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Sep 2025. 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

FDA NDC (as labeled) 0904-6779-61
Product NDC 0904-6779
11-digit billing NDC 00904677961
NCPDP billing unit EA — each (per item)
Application # ANDA201619
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 Discontinued by firm (certified through Sep 2025)
Route ORAL
Dosage form TABLET, COATED
Substance ROSUVASTATIN CALCIUM
GCN Seq No 051784
GCN 19153
HICL code 025009
Ingredient (HICL) Rosuvastatin 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 ROSUVASTATIN CALCIUM 10 MG TAB
FDB brand name Rosuvastatin 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 0904-6779-61 — a 4-4-2 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 labeler segment → 00904-6779-61. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerMajor Pharmaceuticals
Application holderTORRENT PHARMACEUTICALS LTD
FDA applicationANDA201619 (ANDA)
Labeler code00904
Product typeHuman Prescription Drug
Portfolio629 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 ROSUVASTATIN CALCIUM 10 MG TAB Ingredient Rosuvastatin Calcium
📖 What it is MedlinePlus · NLM

Rosuvastatin is used to reduce the risk of heart attack or stroke decrease the amount of cholesterol (a fat-like substance that can build up and clog blood vessels causing heart attack or stroke or other health conditions) Rosuvastatin 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
  • Rosuvastatin lowers the amount of LDL — the "bad" cholesterol — and other fats circulating in your blood, while nudging your "good" cholesterol (HDL) a little higher. Depending on...
  • What exactly is rosuvastatin supposed to do for me?
  • No — you can take rosuvastatin at any time of day that's easiest for you to remember, and food doesn't change how well it's absorbed. The most important thing is taking it consiste...
  • Does it matter what time of day I take it, or whether I take it with food?
📖 Read our full Rosuvastatin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Rosuvastatin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Rosuvastatin 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.

🧪 Inactive Ingredients / Excipients

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.049 $4.89 / 100 tablet
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.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Apr 2022 Sep 2022 Feb 2024 $0.064 $0.047
▼ Down 17% over the last 15 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
Rosuvastatin 10 mg 11788-0131-05 AiPing 500 tablets $0.037 AB Availability likely save 24%
Rosuvastatin Calcium 10 mg 13668-0180-05 Torrent 500 tablets $0.037 AB Availability likely save 24%
Rosuvastatin Calcium 10 mg 13668-0721-05 TORRENT 500 tablets $0.037 AB Availability likely save 24%
Rosuvastatin Calcium 10 mg 16714-0989-01 NorthStar 90 tablets $0.037 AB Availability likely save 24%
Rosuvastatin Calcium 10 mg 24658-0262-45 PURACAP 45 tablets $0.037 AB Availability likely save 24%
Rosuvastatin Calcium 10 mg 27808-0156-01 Cranbury 90 tablets $0.037 AB Availability likely save 24%
Rosuvastatin 10 mg 50228-0117-10 ScieGen 1000 tablets $0.037 AB Availability likely save 24%
Rosuvastatin 10 mg 50268-0709-15 AvPAK 1 tablet $0.037 AB Availability likely save 24%
Rosuvastatin Calcium 10 mg 60687-0245-01 American 1 tablet $0.037 AB Availability likely save 24%
Rosuvastatin Calcium 10 mg 67877-0440-05 Ascend 500 tablets $0.037 AB Availability likely save 24%
Rosuvastatin Calcium 10 mg 72603-0365-01 NorthStar 90 tablets $0.037 AB Availability likely save 24%
Rosuvastatin Calcium 10 mg 82009-0018-10 Quallent 1000 tablets $0.037 AB Availability likely save 24%
Rosuvastatin 10 mg 16729-0285-15 Accord 90 tablets $0.049 AB FDA listed —
Rosuvastatin Calcium 10 mgthis 00904-6779-61 Major 1 tablet $0.049 AB Discontinued —
Crestor 10 mg 00310-7570-90 AstraZeneca 90 tablets $8.813 AB Availability likely +17919%
Rosuvastatin Calcium 10 mg 00615-8533-39 NCS 30 tablets — AB FDA listed —
Rosuvastatin 10 mg 31722-0883-31 Camber 100 tablets — AB FDA listed —
Rosuvastatin 10 mg 33342-0262-07 Macleods 30 tablets — — FDA listed —
Rosuvastatin Calcium 10 mg 42677-0302-01 Shandong 90 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 42708-0190-30 QPharma, 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-2451-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-4738-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-5188-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-5189-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-5745-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-5746-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-5770-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-5771-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-6637-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin 10 mg 50090-7430-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin 10 mg 50090-7431-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-7486-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-7487-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-7492-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-7493-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-7967-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-7968-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 51407-0154-90 Golden 90 tablets — AB FDA listed —
Rosuvastatin 10 mg 51407-0849-10 Golden 1000 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 51655-0062-52 Northwind 30 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 51655-0256-52 Northwind 30 tablets — AB FDA listed —
Rosuvastatin 10 mg 55154-0158-00 Cardinal 1 tablet — AB FDA listed —
Rosuvastatin calcium 10 mg 55700-0998-30 Quality 30 tablets — AB Discontinued —
Rosuvastatin Calcium 10 mg 57237-0169-05 Rising 500 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 60290-0044-01 Umedica 30 tablets — AB FDA listed —
Rosuvastain Calcium 10 mg 62135-0691-90 Chartwell 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 63187-0864-30 Proficient 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 63629-7157-01 Bryant 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 65862-0294-05 Aurobindo 500 tablets — AB FDA listed —
Rosuvastatin 10 mg 67046-1627-03 Coupler 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 68071-2407-09 NuCare 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 68071-3623-09 NuCare 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 68071-3722-09 NuCare 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 68071-5176-09 NuCare 90 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 68462-0262-01 Glenmark 100 tablets — AB FDA listed —
Rosuvastatin 10 mg 68788-4057-02 Preferred 20 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 68788-7086-02 Preferred 20 tablets — AB Discontinued —
Rosuvastatin Calcium 10 mg 68788-8384-02 Preferred 20 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 68788-8775-02 Preferred 20 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 69367-0360-01 Westminster 100 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 69434-0006-02 Zhejiang 90 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 70377-0007-11 Biocon 30 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 70518-4143-02 REMEDYREPACK 90 tablets — AB FDA listed —
Rosuvastatin 10 mg 70518-4303-00 REMEDYREPACK 90 tablets — AB FDA listed —
rosuvstatin 10 mg 70756-0054-12 Lifestar 1000 tablets — — FDA listed —
Rosuvastatin calcium 10 mg 71205-0008-30 Proficient 30 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 71205-0052-30 Proficient 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 71205-0820-30 Proficient 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 71209-0044-04 Cadila 90 tablets — AB FDA listed —
Rosuvastatin 10 mg 71335-0606-01 Bryant 30 tablets — AB Discontinued —
Rosuvastatin Calcium 10 mg 71335-1733-01 Bryant 30 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 71335-1890-01 Bryant 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 71335-2035-01 Bryant 30 tablets — AB FDA listed —
Rosuvastatin 10 mg 71335-2539-01 Bryant 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 71335-9640-01 Bryant 30 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 71610-0215-45 Aphena 45 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 71610-0233-15 Aphena 15 tablets — AB FDA listed —
Rosuvastatin 10 mg 71610-0797-15 Aphena 15 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 71610-0801-45 Aphena 45 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 72205-0003-05 Novadoz 500 tablets — AB FDA listed —
Rosuvastatin 10 mg 82009-0189-05 Quallent 500 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 82804-0291-30 Proficient 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

📍
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.

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

Medicare Part D (outpatient prescription) spending for Rosuvastatin Calcium — the program that covers self-administered drugs. 19 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 Rosuvastatin 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
$119.94M
Claims incl. refills
9.3M
Beneficiaries
7.8M
Spend / beneficiary
$15.47
Spend / claim
$12.87
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 Rosuvastatin Calcium — the ingredient across all brands.

Top reported reactions

Dyspnoea2,778
Fatigue2,694
Pain2,470
Cough2,412
Headache2,118
Nausea1,988
Pneumonia1,881

Reporter sex

28,005 reports
Male · 44%
Female · 56%
Unknown · 0%

Serious outcomes

Hospitalization9,256
Death1,404
Life-threatening1,243
Disabling931
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,581 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00904-6779-61 You're viewing this 100 BLISTER PACK in 1 CARTON (0904-6779-61) / 1 TABLET, COATED in 1 BLISTER PACK 2016-10-31 Discontinued by firm

🧭 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) — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA.
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
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 full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
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 FDA registers it as 0904-6779-61, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00904-6779-61, written without dashes as 00904677961. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00904-6779-61, the first segment (00904) is the labeler code FDA assigned to Major Pharmaceuticals; the middle segment (6779) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (61) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Major Pharmaceuticals is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

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

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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
← 00904-6773-61 · Major 00904-6782-61 · Major →
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.