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Acetaminophen 325 mg Tablet, 20,000-count

by Shield Pharmaceuticals Corp · 20000 TABLET in 1 BOX (83059-0159-0)
NDC 83059-0159-00
🏷️ FDA NDC (as labeled) 83059-0159-0 billing pads the package segment with a zero
On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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 Acetaminophen (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 · Oct 21, 2025 — Defective Container (Kenvue Brands LLC) · FDA recall D-0121-2026
Class II · Aug 20, 2025 — Discoloration (Baxter Healthcare Corporation) · FDA recall D-0596-2025
Class II · May 22, 2025 — cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). (Aurobindo Pharma USA Inc) · FDA recall D-0471-2025
Class I · Jul 8, 2024 — Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) (Hikma Pharmaceuticals USA Inc.) · FDA recall D-0635-2024
Class II · May 20, 2024 — Discoloration: Brownish tablets (Contract Pharmacal Corporation) · FDA recall D-0566-2024
Class II · Nov 13, 2023 — Failed Impurities/Degradation Specifications (KINDER FARMS LLC) · FDA recall D-0143-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 83059-0159-0
Product NDC 83059-0159
11-digit billing NDC 83059015900
SPL Set ID 54784218-116e-ffad-e063-6294a90a4091
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-10
Dosage form TABLET
Substance ACETAMINOPHEN
Why two NDCs? The FDA registers this code as 83059-0159-0 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 83059-0159-00. 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

LabelerShield Pharmaceuticals Corp
Labeler code83059
First marketedJun 2026
Product typeDrug For Further Processing
Portfolio101 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Acetaminophen is a pain reliever and fever reducer. You can use it for everyday aches like headaches, backaches, sore muscles, toothaches, minor arthritis pain, cold-related discom...
  • What is acetaminophen actually used for?
  • That's a smart thing to think about. The biggest danger with acetaminophen is taking more than the maximum daily dose allowed on your product label — especially if you're also taki...
  • How much is too much? I'm worried about taking it too often.
📖 Read our full Acetaminophen guide →
1
Nutrient depletion considerations

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

🧪 Full Acetaminophen 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acetaminophen Regular Strength 325 mg 46122-0430-78 Amerisource 100 tablets $0.024 — Availability likely —
Pain Relief Regular Strength 325 mg 70677-1119-01 STRATEGIC 100 tablets $0.024 — Availability likely —
Acetaminophen 325 mg 57237-0346-01 Rising 100 tablets $0.024 — Availability likely —
Acetaminophen 325 mg 00904-6773-61 Major 100 tablets $0.024 — Availability likely —
Acetaminophen 325 mg 82568-0001-01 AARNA 100 tablets $0.024 — Availability likely —
McKesson Acetaminophen 325 325 mg 68599-4679-09 McKesson 2 tablets $0.024 — Availability likely —
Pain Relief Regular Strength 325 mg 83324-0076-01 CHAIN 100 tablets $0.024 — Availability likely —
Pain Relief Regular Strength 325 mg 46122-0390-78 AmeriSource 100 tablets $0.024 — Availability likely —
good sense pain relief 325 mg 00113-0403-78 L. 100 tablets $0.024 — Availability likely —
Rugby Regular Strength Acetaminophen 325 mg 00536-1327-01 RUGBY 100 tablets $0.024 — Availability likely —
Acetaminophen 325 mg 49483-0340-01 TIME 100 tablets $0.024 — Availability likely —
Pain Relief Regular Strength 325 mg 63868-0082-10 Chain 100 tablets $0.025 — Discontinued —
Regular Strength Acetaminophen 325 mg 70000-0092-01 CARDINAL 100 tablets $0.026 — FDA listed —
Acetaminophen 325 mg 17714-0012-01 Advance 100 tablets — — FDA listed —
Acetaminophen 325 mg 54738-0548-01 Richmond 100 tablets — — FDA listed —
Acetaminophen 325 mg 71610-0238-65 Aphena 100 tablets — — FDA listed —
Acetaminophen Regular Strength 325 mg 30142-0052-21 KROGER 100 tablets — — FDA listed —
Aurophen Regular Strength 325 mg 30142-0184-21 KROGER 100 tablets — — FDA listed —
Ringl 325 mg 49873-0082-01 Sato 30 tablets — — FDA listed —
Rugby Regular Strength Acetaminophen 325 mg 50090-5971-06 A-S 50 tablets — — FDA listed —
Acetaminophen Regular Strength 325 mg 54257-0720-02 Magno-Humphries, 100 tablets — — FDA listed —
Aurophen Regular Strength 325 mg 58602-0754-07 Aurohealth 24 tablets — — FDA listed —
Acetaminophen Regular Strength 325 mg 58602-0775-21 Aurohealth 100 tablets — — FDA listed —
Regular Strength Pain Reliever 325 mg 62936-0102-01 INGLES 100 tablets — — FDA listed —
Acetaminophen 325 mg 69822-0692-10 Southern 325 tablets — — FDA listed —
Aphen 325 mg 76420-0372-15 Asclemed 150 tablets — — FDA listed —
Acetaminophen 325 mg 00615-8397-05 NCS 15 tablets — — FDA listed —
Acetaminophen 325 mg 00615-8608-05 NCS 15 tablets — — FDA listed —
Acetaminophen 325 mg 85828-0102-02 Grocery 100 tablets — — FDA listed —
Acetaminophen 325 mg 68210-4203-00 Prodose, 47000 tablets — — FDA listed —
Acetaminophen 325 mg 70120-0008-02 APL 50000 tablets — — FDA listed —
Pain Relief 325 mg 53943-0201-02 DISCOUNT 100 tablets — — FDA listed —
Regular Strength Pain Relief 325 mg 63941-0456-02 VALU 100 tablets — — FDA listed —
Acetaminophen 325 mg 68071-3454-03 NuCare 30 tablets — — FDA listed —
MEDI-FIRST Non-Aspirin 325 mg 71205-0306-04 Proficient 4 tablets — — FDA listed —
Acetaminophen 325 mg 62485-0033-04 TCB 40000 tablets — — FDA listed —
Acetaminophen Regular Strength 325 mg 41163-0514-02 United 100 tablets — — FDA listed —
pain relief 325 mg 41250-0403-78 Meijer 100 tablets — — FDA listed —
TYLENOL Regular Strength 325 mg 50580-0458-10 Kenvue 1000 tablets — — Discontinued —
CareALL Acetaminophen 325 mg 51824-0085-01 New 100 tablets — — FDA listed —
Acetaminophen 325 mg 69842-0968-01 CVS 100 tablets — — FDA listed —
Regular Strength Pain Relief 325 mg 72162-2252-01 Bryant 100 tablets — — FDA listed —
Amazon Basic Care Acetaminophen 325 mg 72288-0405-10 Amazon.com 100 tablets — — FDA listed —
Pain Relief Regular Strength 325 mg 11822-0104-01 Rite 100 tablets — — FDA listed —
Pain Relief 325 mg 21130-0043-01 BETTER 100 tablets — — FDA listed —
Medi-First Non-Aspirin 325 mg 47682-0058-13 Unifirst 2 tablets — — FDA listed —
Dover Aminofen 325 mg 47682-0060-13 Unifirst 2 tablets — — FDA listed —
Medique APAP 325 mg 47682-0145-13 Unifirst 2 tablets — — FDA listed —
Medi-First Non-Aspirin 325 mg 47682-0803-13 Unifirst 2 tablets — — FDA listed —
Medline 325 mg 53329-0194-30 Medline 100 tablets — — FDA listed —
Acetaminophen 325 mg 55154-7899-00 Cardinal 10 tablets — — FDA listed —
Acetaminophen Regular Strength 325 mg 58602-0748-40 Aurohealth 500 tablets — — FDA listed —
Regular Strength Pain Relief 325 mg 68071-4656-05 NuCare 50 tablets — — FDA listed —
Pain Reliever 325 mg 00363-9026-10 WALGREENS 100 tablets — — FDA listed —
good sense pain relief 325 mg 71335-2574-01 Bryant 100 tablets — — FDA listed —
basic care acetaminophen 325 mg 72288-0403-78 Amazon.com 100 tablets — — FDA listed —
Acetaminophen 325 mg 72789-0267-20 PD-Rx 20 tablets — — FDA listed —
Pain Relief 325 mg 42507-0501-02 HYVEE 100 tablets — — FDA listed —
Dover Aminophen 325 mg 47682-0303-13 Unifirst 2 tablets — — FDA listed —
MEDI FIRST PLUS Non-Aspirin 325 mg 47682-0903-33 Unifirst 2 tablets — — FDA listed —
TYLENOL Regular Strength 325 mg 50580-0495-01 Kenvue 100 tablets — — FDA listed —
CareALL Acetaminophen 325 mg 51824-0061-02 New 2400 tablets — — FDA listed —
Acetaminophen Regular strength 325 mg 55289-0563-01 PD-Rx 100 tablets — — FDA listed —
Pain Relief 325 mg 57344-0301-06 AAA 500 tablets — — FDA listed —
Acetaminophen Regular Strength 325 mg 67091-0132-10 WinCo 100 tablets — — FDA listed —
Acetaminophen 325 Mg 71205-0456-00 Proficient 100 tablets — — FDA listed —
Acetaminophen 325 mg 71399-1025-01 Akron 100 tablets — — FDA listed —
Acetaminophen 325 mg 72036-0100-02 HARRIS 100 tablets — — FDA listed —
Pain Reliever 325 mg 79903-0130-99 WAL-MART 100 tablets — — FDA listed —
Acetaminophen 325 mg 00615-8609-67 NCS 60 tablets — — FDA listed —
Medique APAP 325 mg 47682-0057-13 Unifirst 2 tablets — — FDA listed —
dg health pain relief 325 mg 55910-0697-78 Dolgencorp, 100 tablets — — FDA listed —
Acetaminophen 325 Mg 69618-0010-01 Reliable 100 tablets — — FDA listed —
Henry Schein Acetaminophen 325 mg 00404-0714-13 Henry 2 tablets — — FDA listed —
Acetaminophen 325 mg 14803-0013-00 Elysium 47000 tablets — — FDA listed —
Pain Relief Regular Strength 325 mg 41250-0501-02 Meijer 100 tablets — — Discontinued —
PAIN RELIEF Regular Strength 325 mg 41520-0606-02 AMERICAN 100 tablets — — FDA listed —
Cetafen 325 mg 50332-0148-01 HART 1000 tablets — — FDA listed —
Duralgina 325 mg 53145-0013-71 Menper 30 tablets — — FDA listed —
Regular Strength Pain Relief 325 mg 57896-0102-01 Geri-Care 100 tablets — — FDA listed —
good sense pain relief 325 mg 68071-3917-06 NuCare 6 tablets — — FDA listed —
DRX CHOICE Regular Strength 325 mg 68163-0065-60 Raritan 60 tablets — — FDA listed —
Acetaminophen 325 mg 71335-3130-00 Bryant 24 tablets — — FDA listed —
Dr Simi Pain Relief 325 mg 85786-0103-90 Farmacias 100 tablets — — FDA listed —
Pain Relief Regular Strength 325 mg 36800-0900-02 TopCo 100 tablets — — FDA listed —
acetaminophen 325 mg 51662-1665-02 HF 2 tablets — — FDA listed —
Clear Choice Regular Strength Pain Reliever 325 mg 53185-0005-00 Athlete's 100 tablets — — FDA listed —
Acetaminophen 325 mg 58228-0061-01 Prostat 20000 tablets — — FDA listed —
Direct Safety Aspirin Free 325 mg 61245-0145-13 Conney 2 tablets — — FDA listed —
Regular Strength Pain Relief 325 mg 68071-3565-00 NuCare 100 tablets — — FDA listed —
Pain Relief Regular Strength 325 mg 68998-0301-01 MARC 100 tablets — — FDA listed —
Acetaminophen Regular Strength 325 mg 69842-0876-51 CVS 365 tablets — — FDA listed —
Pharbetol Regular strength 325 mg 17856-0353-01 ATLANTIC 100 tablets — — FDA listed —
Medi-First Plus Non-Aspirin 325 mg 47682-0059-33 Unifirst 2 tablets — — FDA listed —
Regular Strength Pain Reliever 325 mg 70677-1243-01 Strategic 120 tablets — — FDA listed —
Acetaminophen 325 mgthis 83059-0159-00 Shield 20000 tablets — — FDA listed —
Pharbetol Regular strength 325 mg 16103-0353-07 Pharbest 60 tablets — — FDA listed —
Regular Strength Acetaminophen 325 mg 41226-0340-01 KROGER 100 tablets — — FDA listed —
good sense pain relief 325 mg 68071-3883-02 NuCare 20 tablets — — FDA listed —
Acetaminophen 325 mg 71335-2747-00 Bryant 24 tablets — — FDA listed —
equate pain reliever 325 mg 79903-0299-10 WALMART 100 tablets — — FDA listed —
Acetaminophen 325 mg 00615-8398-67 NCS 60 tablets — — FDA listed —
Acetaminophen 325mg 325 mg 10135-0828-01 Marlex 100 tablets — — FDA listed —
Medique at Home APAP 325 mg 47682-0434-33 Unifirst 2 tablets — — FDA listed —
TYLENOL Regular Strength 325 mg 50580-0475-10 Kenvue 1000 tablets — — FDA listed —
TYLENOL Regular Strength 325 mg 50580-0496-60 Kenvue 100 tablets — — FDA listed —
Pain Relief 325 mg 53942-0101-02 Demoulas 100 tablets — — FDA listed —
good sense pain relief 325 mg 68788-8821-01 Preferred 100 tablets — — FDA listed —
Acetaminophen 325 mg 71679-0305-00 Health 47000 tablets — — FDA listed —
Acetaminophen 325 mg 69732-0002-01 Hi-Tech 30 tablets — — FDA listed —
Pain Relief Acetaminophen 325 mg 84324-0046-01 NUVICARE 300 tablets — — FDA listed —
Gencare- Pain Relief Acetaminophen 325 mg 72090-0069-01 Pioneer 1000 tablets — — FDA listed —
Acetaminophen 325 mg 87550-0007-01 EFDEE 40000 tablets — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2026
On the market since
Jun 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

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

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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

Medicare Part D (outpatient prescription) spending for Acetaminophen (matched by generic name) — the program that covers self-administered drugs. 5 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 Acetaminophen. 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
$34K
Claims incl. refills
277
Beneficiaries
145
Spend / beneficiary
$234.25
Spend / claim
$122.62
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 Acetaminophen — the ingredient across all brands.

Top reported reactions

Pain49,512
Fatigue45,791
Nausea41,932
Overdose40,941
Drug Dependence39,209
Headache38,738
Death36,479

Age at onset

Neonate2,511
Infant1,510
Child4,320
Adolescent3,245
Adult56,522
Elderly41,990

Reporter sex

679,604 reports
Male · 36%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization199,486
Death102,045
Life-threatening29,552
Disabling25,685
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 54,527 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
83059-0159-00 You're viewing this 20000 TABLET in 1 BOX (83059-0159-0) — Active

🧭 About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Shield Pharmaceuticals Corp supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 83059-0159-0, 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: 83059-0159-00, written without dashes as 83059015900. 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 83059-0159-00, the first segment (83059) is the labeler code FDA assigned to Shield Pharmaceuticals Corp; the middle segment (0159) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Shield Pharmaceuticals Corp. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Shield Pharmaceuticals Corp is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full FDA label FDA SPL

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

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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 83059-0129-01 · Shield
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.