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TRICITRATES POTASSIUM CITRATE, SODIUM CITRATE, and CITRIC ACID MONOHYDRATE 550 mg/5mL; 500 mg/5mL; 334 mg/5mL Solution, 473 mL — NDC 00121-0677-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

TRICITRATES POTASSIUM CITRATE, SODIUM CITRATE, and CITRIC ACID MONOHYDRATE 550 mg/5mL; 500 mg/5mL; 334 mg/5mL Solution, 473 mL — NDC 0121-0677-16 (Billing 00121-0677-16)

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

This is a package of 473 mL of TRICITRATES POTASSIUM CITRATE, SODIUM CITRATE, and CITRIC ACID MONOHYDRATE 550 mg/5mL; 500 mg/5mL; 334 mg/5mL Solution from PAI Holdings, LLC dba PAI Pharma, marketed since May 2005 and currently FDA-listed; retail pharmacies pay about $0.0314 per mL (NADAC). It is this product's only package size.

NDC 00121-0677-16
🏷️ FDA NDC (as labeled) 0121-0677-16 billing pads the labeler segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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 0121-0677-16 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0121 labeler · 0677 product · 16 package
Package marketed since
May 25, 2005
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
473 mL per package
Barcode (UPC)
0301210677168
Medicaid fills, this package
724 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0121-0677-16
Product NDC 0121-0677
11-digit billing NDC 00121067716
NCPDP billing unit ML — per mL (volume)
RxCUI 309317
UNII EE90ONI6FF, 1Q73Q2JULR, 2968PHW8QP
UPC 0301210677168
SPL Set ID 2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad
Established class (EPC) Anti-coagulant; Calcul
Mechanism of action Acidifying Activity; Calcium Chelating Activity
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2005-05-25
Route ORAL
Dosage form SOLUTION
Substance POTASSIUM CITRATE; SODIUM CITRATE; CITRIC ACID MONOHYDRATE

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

GPI-14 56202030102020
GPI class Tricitrates
GCN Seq No 048561
GCN 14027
HICL code 003681
Ingredient (HICL) Sod/Pot/K Cit/Sod Cit/Cit Acid
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1S
Therapeutic class — specific (HIC3) Urinary Ph Modifiers
AHFS code 40:08.00.00
AHFS class Alkalinizing Agents
FDB label name TRICITRATES ORAL SOLUTION
FDB brand name Tricitrates
Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Quick answers
  • GSN (GCN sequence number): 048561
  • GCN: 14027
  • GPI-14 (Medi-Span): 56202030102020
  • HICL (First Databank): 003681
  • AHFS class code: 40:08.00.00
  • RxCUI (RxNorm): 309317
Why two NDCs? The FDA registers this code as 0121-0677-16 — 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 → 00121-0677-16. 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 Calculi Dissolution Agent class.

Pharmacologic class Calculi Dissolution Agent, Anti-coagulant
Drug family (ATC) Acid preparations
How it works Calcium Chelating Activity, Acidifying Activity
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 TRICITRATES ORAL SOLUTION Ingredient Sod/Pot/K Cit/Sod Cit/Cit Acid
🧪 What is this product?

Tricitrates is an oral liquid solution containing potassium citrate, sodium citrate, and citric acid monohydrate. These citrate salts are typically used to make urine less acidic, which may help prevent or dissolve certain types of kidney stones and manage conditions where urine acidity needs to be reduced. This product is marketed without an approved FDA application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 $0.031 $14.85 / 473 ml
Medicaid paysCMS SDUD · 12 mo $0.0502 $23.74 / 473 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Feb 2021 Jan 2026 May 2026 Sep 2026 $0.036 $0.029
▼ Down 4% over the last 12 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
00121-0677-16 You're viewing this Main listing 473 mL in 1 BOTTLE 2005-05-25 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tricitrates 550 mg/5mL; 500 mg/5mL; 334 mg/5mLthis 00121-0677-16 PAI 473 ml $0.031 — Availability likely —
Tricitrates 550 mg/5mL; 500 mg/5mL; 334 mg/5mL 62135-0438-47 Chartwell 473 ml $0.031 — Availability likely —
Tricitrates 550 mg/5mL; 500 mg/5mL; 334 mg/5mL 68999-0438-24 Chartwell 10 cups — — 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

🏛️
2005
On the market since
May 2005
📍
2026
Currently FDA-listed
21 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 orange
FlavorRaspberry
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 H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 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

LabelerPAI Holdings, LLC dba PAI Pharma
Labeler code00121
First marketedMay 2005
Product typeHuman Prescription Drug
Portfolio142 products on file

More NDCs from PAI Holdings, LLC dba PAI Pharma labeler code 00121

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 ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 151 words ▾

INDICATIONS AND ADVANTAGES Tricitrates SF Oral Solution is an effective alkalinizing agent useful in those conditions where long-term maintenance of an alkaline urine is desirable, such as in patients with uric acid and cystine calculi of the urinary tract. In addition, it is a valuable adjuvant when administered with uricosuric agents in gout therapy, since urates tend to crystallize out of an acid urine. It is also effective in correcting the acidosis of certain renal tubular disorders.

This product is highly concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urine pH around the clock, usually without the necessity of a 2 A.M. dose. This product alkalinizes the urine without producing a systemic alkalosis in recommended dosage. It is highly palatable, pleasant tasting, and tolerable, even when administered for long periods.

Potassium citrate and sodium citrate do not neutralize the gastric juice or disturb digestion.

⏱️ Dosage and Administration 164 words ▾

DOSAGE AND ADMINISTRATION Tricitrates SF Oral Solution should be taken diluted in water, followed by additional water, if desired. Palatability is enhanced if chilled before taking. Usual Adult Dose 3 to 6 teaspoonfuls (15 to 30 mL), diluted in water, four times a day, after meals and at bedtime, or as directed by a physician.

Usual Pediatric Dose 1 to 3 teaspoonfuls (5 to 15 mL), diluted in water, four times a day, after meals and at bedtime, or as directed by a physician. Usual Dosage Range 2 to 3 teaspoonfuls (10 to 15 mL), diluted with water, taken four times a day, will usually maintain a urinary pH of 6.5-7.4. 3 to 4 teaspoonfuls (15 to 20 mL), diluted with water, taken four times a day, will usually maintain a urinary pH of 7.0-7.6 throughout most of the 24 hours without unpleasant side effects.

To check urine pH, HYDRION Paper (pH 6.0-8.0) or NITRAZINE Paper (pH 4.5-7.5) are available and easy to use.

⛔ Contraindications 49 words ▾

CONTRAINDICATIONS Severe renal impairment with oliguria or azotemia, untreated Addison's disease, or severe myocardial damage. In certain situations, when patients are on a sodium-restricted diet, the use of potassium citrate may be preferable; or, when patients are on a potassium-restricted diet, the use of sodium citrate may be preferable.

⚠️ Warnings 137 words ▾

PRECAUTIONS AND WARNINGS Should be used with caution by patients with low urinary output or reduced glomerular filtration rates unless under the supervision of a physician. Aluminum-based antacids should be avoided in these patients. Patients should be directed to dilute adequately with water and, preferably, to take each dose after meals, to minimize the possibility of gastrointestinal injury associated with oral ingestion of potassium salt preparations and to avoid saline laxative effect.

Sodium salts should be used cautiously in patients with cardiac failure, hypertension, peripheral and pulmonary edema, and toxemia of pregnancy. Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, or cardiac glycosides may lead to toxicity. Periodic examination and determinations of serum electrolytes, particularly serum bicarbonate level, should be carried out in those patients with renal disease in order to avoid these complications.

🤒 Adverse Reactions 70 words ▾

ADVERSE REACTIONS Tricitrates SF Oral Solution is generally well tolerated without any unpleasant side effects when given in recommended doses to patients with normal renal function and urinary output. However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of hyperkalemia or alkalosis, especially in the presence of hypocalcemia. Potassium intoxication causes listlessness, weakness, mental confusion, and tingling of extremities.

🆘 Overdosage 30 words ▾

OVERDOSAGE Overdosage with sodium salts may cause diarrhea, nausea and vomiting, hypernoia, and convulsions. Overdosage with potassium salts may cause hyperkalemia and alkalosis, especially in the presence of renal disease.

🧬 Mechanism of Action 53 words ▾

ACTIONS Potassium citrate and sodium citrate are absorbed and metabolized to potassium bicarbonate and sodium bicarbonate, thus acting as systemic alkalizers. The effects are essentially those of chlorides before absorption and those of bicarbonates subsequently. Oxidation is virtually complete so that less than 5% of the citrates are excreted in the urine unchanged.

📦 How Supplied / Storage and Handling 47 words ▾

HOW SUPPLIED Tricitrates SF Oral Solution (orange colored, raspberry flavored) is supplied in the following oral dosage form: NDC 0121-0677-16: 16 fl oz (473 mL) bottles STORAGE Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from excessive heat and freezing. SHAKE WELL BEFORE USING.

📦 Storage and Handling 21 words ▾

STORAGE Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from excessive heat and freezing. SHAKE WELL BEFORE USING.

📋 Description 91 words ▾

DESCRIPTION Tricitrates SF Oral Solution is a stable and pleasant-tasting oral systemic alkalizer containing potassium citrate, sodium citrate, and citric acid in a sugar-free, non-alcoholic base. Tricitrates SF Oral Solution contains in each teaspoonful (5 mL): POTASSIUM CITRATE Monohydrate 550 mg SODIUM CITRATE Dihydrate 500 mg CITRIC ACID Monohydrate 334 mg Each mL contains 1 mEq potassium ion and 1 mEq sodium ion and is equivalent to 2 mEq bicarbonate (HCO 3 ). Inactive Ingredients: FD&C Yellow No.

6, flavoring, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sorbitol solution.

⚠️ Precautions 134 words ▾

Should be used with caution by patients with low urinary output or reduced glomerular filtration rates unless under the supervision of a physician. Aluminum-based antacids should be avoided in these patients. Patients should be directed to dilute adequately with water and, preferably, to take each dose after meals, to minimize the possibility of gastrointestinal injury associated with oral ingestion of potassium salt preparations and to avoid saline laxative effect.

Sodium salts should be used cautiously in patients with cardiac failure, hypertension, peripheral and pulmonary edema, and toxemia of pregnancy. Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, or cardiac glycosides may lead to toxicity. Periodic examination and determinations of serum electrolytes, particularly serum bicarbonate level, should be carried out in those patients with renal disease in order to avoid these complications.

📄 Package Label / Principal Display Panel 94 words ▾

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 0121-0677-16 Tricitrates SF Oral Solution 550 mg/500 mg/334 mg per 5 mL A SUGAR-FREE SYSTEMIC ALKALIZER Each teaspoonful (5 mL) contains: Potassium Citrate Monohydrate 550 mg Sodium Citrate Dihydrate 500 mg Citric Acid Monohydrate 334 mg Each mL contains 1 mEq Potassium Ion and 1 mEq Sodium Ion, and is equivalent to 2 mEq Bicarbonate (HCO 3 ). May not meet USP monograph requirements for pH. 16 fl oz (473 mL) Pharmaceutical Associates, Inc.

Greenville, SC 29605 PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

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 – Q1 2026 · 5 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
724
Units reimbursed last 4 qtrs
737.9K
Gross reimbursed last 4 qtrs
$37.1K
Avg / prescription
$51.19
Avg / unit
$0.0502
Latest quarter Q1 2026
178Rx
Medicaid pays / mL
$0.0502
gross reimbursed
vs
NADAC / mL
$0.0314
acquisition cost
=
Spread
+$0.0188
+60% 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 ⓘ
60% FFS 40% MCO
Fee-for-service · 434 Rx Managed care · 290 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 33,655 units · 587 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 27,836 units · 406 per 100k residents IN Ohio: no data reported OH Pennsylvania: 16,343 units · 126 per 100k residents PA New Jersey: 11,488 units · 124 per 100k residents NJ Massachusetts: 58,732 units · 839 per 100k residents MA California: 273,097 units · 701 per 100k residents CA Utah: no data reported UT Colorado: 79,708 units · 1,356 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 30,879 units · 285 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 206,152 units · 676 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
1241,356
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 Colorado 1,356 /100k
2 Massachusetts 839 /100k
3 California 701 /100k
4 Texas 676 /100k
5 Minnesota 587 /100k
6 Indiana 406 /100k
7 North Carolina 285 /100k
8 Pennsylvania 126 /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 Tricitrates — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Tricitrates. 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
$3.5K
Claims incl. refills
26
Beneficiaries
16
Spend / beneficiary
$218.94
Spend / claim
$134.73
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 Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) ✓ Available
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) ✓ 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

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 "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
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.
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 PAI Holdings, LLC dba PAI Pharma. Listing status can change — the directory data on this page refreshes weekly.
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.
← 00121-0676-16 · PAI 00121-0678-16 · 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.