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Nystatin 100000 [USP'U]/mL Suspension, 473 mL — NDC 0121-1045-16 (Billing 00121-1045-16)

by PAI Holdings, LLC dba PAI Pharma · 473 mL in 1 BOTTLE

This is a package of 473 mL of Nystatin 100000 [USP'U]/mL Suspension from PAI Holdings, LLC dba PAI Pharma, no longer marketed (first marketed Jun 2024), no longer in the FDA NDC Directory; retail pharmacies pay about $0.0584 per mL (NADAC). It is this product's only package size.

NDC 00121-1045-16
🏷️ FDA NDC (as labeled) 0121-1045-16 billing pads the labeler segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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 Nystatin (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 23, 2026 — Subpotent Drug: Low out of specification assay results performed during long-term stability testing. (Padagis US LLC) · FDA recall D-0677-2026
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 Aug 2026. 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) 0121-1045-16
Product NDC 0121-1045
11-digit billing NDC 00121104516
NCPDP billing unit ML — per mL (volume)
RxCUI 312055
UNII BDF1O1C72E
Application # ANDA203621
SPL Set ID 05a8b8b6-3639-47b8-b7fc-47b105f5e6f9
Established class (EPC) Polyene Antifungal
Chemical class Polyenes
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Aug 2026)
Marketing start 2024-06-21
Route ORAL
Dosage form SUSPENSION
Substance NYSTATIN
TE code (Orange Book) AA · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 009537
GCN 42440
HICL code 004129
Ingredient (HICL) Nystatin
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W3
Therapeutic class — intermediate (HIC2) Antimycotics
HIC3 code W3A
Therapeutic class — specific (HIC3) Antifungal Antibiotics
AHFS code 08:14.28.00
AHFS class Polyene Antifungals
FDB label name NYSTATIN 100,000 UNIT/ML SUSP
FDB brand name Nystatin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 009537
  • GCN: 42440
  • HICL (First Databank): 004129
  • AHFS class code: 08:14.28.00
  • RxCUI (RxNorm): 312055
Why two NDCs? The FDA registers this code as 0121-1045-16 — 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 → 00121-1045-16. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Polyene Antifungal class.

Pharmacologic class Polyene Antifungal
Drug family (ATC) Antibiotics, Antibiotics, Antibiotics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name NYSTATIN 100,000 UNIT/ML SUSP Ingredient Nystatin
📖 What it is MedlinePlus · NLM

Nystatin is used to treat fungal infections of the inside of the mouth and lining of the stomach and intestines. Nystatin is in a class of antifungal medications called polyenes. It works by stopping the growth of fungi that cause infection.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats Candida yeast infections. Creams, ointment and powder are for the skin. The liquid is for the mouth. Tablets are for the digestive tract lining.
  • Place half the dose in each side of your mouth and keep it there as long as you can before swallowing. For babies, use the dropper and avoid feeding for 5 to 10 minutes. Keep going...
  • How do I use the liquid for a mouth infection?
  • Cream and ointment are usually applied twice a day. Powders are used two or three times a day. Keep using it until the area has healed, and follow your prescriber’s directions.
📖 Read our full Nystatin guide →
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 mLPer package
Retail pharmacies payNADAC · weekly $0.058 $27.62 / 473 ml
Medicaid paysCMS SDUD · 12 mo $0.1136 $53.73 / 473 ml
Medicare drug plans payPart D · Q2 2026 $0.1064 $50.33 / 473 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $0.065 $0.058
▼ Down 7% over the last 9 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00121-1045-16 You're viewing this Main listing 473 mL in 1 BOTTLE 2024-06-21 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nystatin 100000 [USP'U]/mL 69315-0504-47 Leading 473 ml $0.057 AA Availability likely save 3%
Nystatin 100000 U/mL 85742-0013-11 Kanchan 473 ml $0.057 AA Availability likely save 3%
Nystatin 100000 [USP'U]/mLthis 00121-1045-16 PAI 473 ml $0.058 AA Discontinued —
Nystatin 100000 U/mL 62135-0813-46 Chartwell 60 ml $0.140 AA Availability likely +139%
Nystatin 100000 [USP'U]/mL 00121-0868-00 PAI 10 cups $0.176 AA FDA listed +200%
Nystatin 100000 [USP'U]/mL 00904-7276-70 Major 10 cups $0.176 AA FDA listed +200%
Nystatin 100000 [USP'U]/mL 60687-0800-17 American 10 cups $0.176 AA FDA listed +200%
Nystatin Oral Suspension 100000 [USP'U]/mL 00116-4026-11 Xttrium 10 cups — AA FDA listed —
Nystatin 100000 [USP'U]/mL 00121-0810-02 Pharmaceutical 60 ml — AA FDA listed —
Nystatin 100000 [USP'U]/mL 00121-4810-00 Pharmaceutical 10 cups — AA FDA listed —
Nystatin 100000 [USP'U]/mL 17856-0508-01 ATLANTIC 72 cups — AA FDA listed —
Nystatin 100000 [USP'U]/mL 17856-1045-01 ATLANTIC 72 cups — AA Discontinued —
Nystatin 100000 [USP'U]/mL 50090-1740-00 A-S 60 ml — AA FDA listed —
Nystatin 100000 [USP'U]/mL 50090-5315-00 A-S 60 ml — AA FDA listed —
Nystatin 100000 [USP'U]/mL 51672-4117-00 Taro 3785 ml — — Discontinued —
Nystatin 100000 [USP'U]/mL 55154-4314-05 Cardinal 5 cups — AA FDA listed —
Nystatin 100000 [USP'U]/mL 55154-5788-05 Cardinal 5 cups — AA FDA listed —
Nystatin 100000 [USP'U]/mL 63629-8520-01 Bryant 473 ml — AA FDA listed —
Nystatin 100000 [USP'U]/mL 64950-0372-06 Genus 60 ml — AA FDA listed —
Nystatin 100000 [USP'U]/mL 68071-3543-06 NuCare 1 bottle — AA FDA listed —
Nystatin 100000 [USP'U]/mL 68788-8561-04 Preferred 473 ml — AA FDA listed —
Nystatin 100000 U/mL 68999-0813-24 Chartwell 10 cups — AA FDA listed —
Nystatin 100000 U/mL 72162-2645-02 Bryant 473 ml — AA FDA listed —
Nystatin 100000 U/mL 81033-0015-01 Kesin 100 cups — AA 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

🏛️
2024
On the market since
Jun 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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

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.

Manufacturer & labeler

LabelerPAI Holdings, LLC dba PAI Pharma
Application holderPHARMACEUTICAL ASSOCIATES INC
FDA applicationANDA203621 (ANDA)
Labeler code00121
First marketedJun 2024
Product typeHuman Prescription Drug
Portfolio142 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 17 words ▾

INDICATIONS AND USAGE Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.

⏱️ Dosage and Administration 112 words ▾

DOSAGE AND ADMINISTRATION INFANTS: 2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes). NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective. CHILDREN AND ADULTS: 4 to 6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth).

The preparation should be retained in the mouth as long as possible before swallowing. Continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans .

⛔ Contraindications 17 words ▾

CONTRAINDICATIONS The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.

🤒 Adverse Reactions 77 words ▾

ADVERSE REACTIONS Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported. (See PRECAUTIONS: General ).

Gastrointestinal: Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances. Dermatologic: Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.

Other: Tachycardia, bronchospasm, facial swelling, and non-specific myalgia have also been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 52 words ▾

Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with nystatin oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin oral suspension should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 7 words ▾

Pediatric Use See DOSAGE AND ADMINISTRATION .

🆘 Overdosage 34 words ▾

OVERDOSAGE Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects of superinfections (See CLINICAL PHARMACOLOGY, Pharmacokinetics ).

🧬 Clinical Pharmacology 125 words ▾

CLINICAL PHARMACOLOGY Pharmacokinetics Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur.

Microbiology Nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. Candida albicans demonstrates no significant resistance to nystatin in vitro on repeated subculture in increasing levels of nystatin; other Candida species become quite resistant. Generally, resistance does not develop in vivo .

Nystatin acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

📦 How Supplied / Storage and Handling 132 words ▾

HOW SUPPLIED Nystatin Oral Suspension USP, 100,000 USP Nystatin Units per mL, is available in a cherry flavored, light creamy yellow, ready-to-use suspension, supplied in the following oral dosage forms: NDC 0121-1045-02: 2 fl oz (60 mL) bottle with calibrated dropper NDC 0121-1045-16: 16 fl oz (473 mL) bottle NDC 0121-4045-05: 5 mL unit dose cup. Case contains 40 unit dose cups of 5 mL (NDC 0121-4045-40) packaged in 4 trays of 10 unit dose cups each, 50 unit dose cups of 5 mL (NDC 0121-4045-50) packaged in 5 trays of 10 unit dose cups each and 100 unit dose cups of 5 mL (NDC 0121-4045-00) packaged in 10 trays of 10 unit dose cups each.

Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing.

📦 Storage and Handling 16 words ▾

Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing.

📋 Description 71 words ▾

DESCRIPTION Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei . Structural formula: C 47 H 75 NO 17 MW 926.13 Nystatin Oral Suspension USP, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), cherry flavor, citric acid, D&C Yellow No.

10, FD&C Red No. 40, glycerin, magnesium aluminum silicate, methylparaben, potassium phosphate dibasic, propylene glycol, propylparaben, purified water and sucrose. Chemical structure

⚠️ Precautions 152 words ▾

PRECAUTIONS General This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential.

There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females. Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with nystatin oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Nystatin oral suspension should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman.

Pediatric Use See DOSAGE AND ADMINISTRATION .

🍼 Nursing Mothers 33 words ▾

Nursing Mothers It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman.

🧬 Pharmacokinetics 37 words ▾

Pharmacokinetics Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 35 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.

📄 Package Label / Principal Display Panel 88 words ▾

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label 60 mL NDC 0121-1045-02 Nystatin Oral Suspension, USP 100,000 units per mL SHAKE WELL BEFORE USING Packaged with Calibrated Dropper DO NOT USE IF TAMPER EVIDENT SEAL IS BROKEN OR MISSING. Rx only PAI Pharma Greenville, SC 29605 E Nystatin-60 mL bottle

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 0121-1045-16 Nystatin Oral Suspension, USP 100,000 units per mL SHAKE WELL BEFORE USING Cherry Flavored Rx only 16 fl oz (473 mL) PAI Pharma Greenville, SC 29605 Nystatin-473 mL

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
42.3K
Units reimbursed last 4 qtrs
6.3M
Gross reimbursed last 4 qtrs
$715.6K
Avg / prescription
$16.94
Avg / unit
$0.1136
Latest quarter Q4 2025
1.9KRx
Medicaid pays / mL
$0.1136
gross reimbursed
vs
NADAC / mL
$0.0584
acquisition cost
=
Spread
+$0.0552
+95% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
42% FFS 58% MCO
Fee-for-service · 17,931 Rx Managed care · 24,323 Rx
State Medicaid map
Alaska: 12,490 units · 1,704 per 100k residents AK Maine: 30,136 units · 2,160 per 100k residents ME Washington: 101,369 units · 1,298 per 100k residents WA Idaho: 30,631 units · 1,560 per 100k residents ID Montana: 14,348 units · 1,267 per 100k residents MT North Dakota: 2,336 units · 298 per 100k residents ND Minnesota: 130,760 units · 2,279 per 100k residents MN Wisconsin: 174,706 units · 2,956 per 100k residents WI Michigan: 280,467 units · 2,794 per 100k residents MI New York: 639,536 units · 3,268 per 100k residents NY Vermont: 14,700 units · 2,272 per 100k residents VT New Hampshire: 21,759 units · 1,552 per 100k residents NH Oregon: 55,751 units · 1,317 per 100k residents OR Nevada: 56,789 units · 1,778 per 100k residents NV Wyoming: 5,196 units · 890 per 100k residents WY South Dakota: 8,365 units · 910 per 100k residents SD Iowa: 71,862 units · 2,241 per 100k residents IA Illinois: 182,681 units · 1,456 per 100k residents IL Indiana: 125,307 units · 1,826 per 100k residents IN Ohio: 280,038 units · 2,376 per 100k residents OH Pennsylvania: 260,254 units · 2,008 per 100k residents PA New Jersey: 149,249 units · 1,607 per 100k residents NJ Massachusetts: 120,635 units · 1,723 per 100k residents MA California: 843,974 units · 2,166 per 100k residents CA Utah: 16,708 units · 489 per 100k residents UT Colorado: 83,834 units · 1,426 per 100k residents CO Nebraska: 38,250 units · 1,934 per 100k residents NE Missouri: 142,359 units · 2,298 per 100k residents MO Kentucky: 246,337 units · 5,443 per 100k residents KY West Virginia: 72,509 units · 4,097 per 100k residents WV Virginia: 122,488 units · 1,405 per 100k residents VA Maryland: 110,834 units · 1,793 per 100k residents MD Connecticut: 91,972 units · 2,543 per 100k residents CT Rhode Island: 16,333 units · 1,492 per 100k residents RI Arizona: 108,050 units · 1,454 per 100k residents AZ New Mexico: 43,488 units · 2,057 per 100k residents NM Kansas: 26,355 units · 896 per 100k residents KS Arkansas: 63,953 units · 2,085 per 100k residents AR Tennessee: 189,900 units · 2,665 per 100k residents TN North Carolina: 241,820 units · 2,232 per 100k residents NC South Carolina: 50,412 units · 938 per 100k residents SC Delaware: 30,251 units · 2,934 per 100k residents DE Oklahoma: 90,599 units · 2,235 per 100k residents OK Louisiana: 152,282 units · 3,329 per 100k residents LA Mississippi: 55,942 units · 1,903 per 100k residents MS Alabama: 98,692 units · 1,932 per 100k residents AL Georgia: 101,911 units · 924 per 100k residents GA D.C.: 11,893 units · 1,752 per 100k residents DC Hawaii: 8,217 units · 573 per 100k residents HI Texas: 288,299 units · 945 per 100k residents TX Florida: 177,928 units · 787 per 100k residents FL
Units reimbursed · per 100k residents
2985,443
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Kentucky 5,443 /100k
2 West Virginia 4,097 /100k
3 Louisiana 3,329 /100k
4 New York 3,268 /100k
5 Wisconsin 2,956 /100k
6 Delaware 2,934 /100k
7 Michigan 2,794 /100k
8 Tennessee 2,665 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Nystatin — the program that covers self-administered drugs. 22 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 Nystatin. 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
$16.29M
Claims incl. refills
853.7K
Beneficiaries
614.3K
Spend / beneficiary
$26.52
Spend / claim
$19.08
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) — 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) ✓ Available
“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

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.
Who lists this product with the FDA?
PAI Holdings, LLC dba PAI Pharma 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.
← 00121-1038-00 · PAI 00121-1047-00 · PAI →
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.