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Sincalide 5 ug/5mL Injection, Powder, Lyophilized, For Solution — NDC 70511-0131-84 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sincalide 5 ug/5mL Injection, Powder, Lyophilized, For Solution — NDC 70511-131-84 (Billing 70511-0131-84)

by MAIA Pharmaceuticals, Inc. · 10 VIAL in 1 PACKAGE / 5 mL in 1 VIAL

This is a package of Sincalide 5 ug/5mL Injection, Powder, Lyophilized, For Solution from MAIA Pharmaceuticals, Inc., marketed since Nov 2022 and currently FDA-listed. It is this product's only package size.

NDC 70511-0131-84
🏷️ FDA NDC (as labeled) 70511-131-84 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70511-131-84
Product NDC 70511-131
11-digit billing NDC 70511013184
RxCUI 237982
UNII M03GIQ7Z6P
Application # NDA210850
SPL Set ID 4149af34-7b3d-4200-9609-ea856b1d6aab
Established class (EPC) Cholecystokinin Analog
Chemical class Cholecystokinin
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-11-25
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance SINCALIDE
TE code (Orange Book) AP · RLD · RS
Quick answers
  • RxCUI (RxNorm): 237982
Why two NDCs? The FDA registers this code as 70511-131-84 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 70511-0131-84. 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 Cholecystokinin Analog class.

Pharmacologic class Cholecystokinin Analog
Drug family (ATC) Tests for bile duct patency
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

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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70511-0131-84 You're viewing this Main listing 10 VIAL in 1 PACKAGE / 5 mL in 1 VIAL 2022-11-25 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Kinevac 5 ug/5mL 00270-0556-15 Bracco 10 vials — AP FDA listed —
Sincalide 5 ug/5mL 63323-0579-05 Fresenius 10 vials — AP FDA listed —
Sincalide 5 ug/5mLthis 70511-0131-84 MAIA 10 vials — AP FDA listed —
Sincalide 5 ug/5mL 72266-0248-05 FOSUN 5 vials — AP FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2022
First FDA approval
Nov 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2038
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Apr 2038. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Nov 22, 2022 AP TE-rated RLD RS ⏳ ~11.5 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11737983 — method of use (U-3482)
US 11737983 — method of use (U-3689)
US 11318100 — method of use (U-3477)
US 11318100 — method of use (U-3478)
US 11318100 — method of use (U-3479)
US 11318100 — method of use (U-3480)
US 11110063 — method of use (U-3481)
US 11110063 — method of use (U-3482)
US 11110063 — method of use (U-3483)
2022 2024 2026 2028 2030 2032 2034 2036 2038
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (9)
PatentTypeUse codeExpires
US 11737983 ↗ Method of use U-3482 Apr 20, 2038
US 11737983 ↗ Method of use U-3689 Apr 20, 2038
US 11318100 ↗ Method of use U-3477 Apr 20, 2038
US 11318100 ↗ Method of use U-3478 Apr 20, 2038
US 11318100 ↗ Method of use U-3479 Apr 20, 2038
US 11318100 ↗ Method of use U-3480 Apr 20, 2038
US 11110063 ↗ Method of use U-3481 Apr 20, 2038
US 11110063 ↗ Method of use U-3482 Apr 20, 2038
US 11110063 ↗ Method of use U-3483 Apr 20, 2038
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Apr 2038 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 30 mg / 5 mL UNII F7LTH1E20Y
    Arginine hydrochloride is an amino acid salt used as a buffer and pH adjuster in medicines. It helps maintain the correct acidity level to keep the drug stable and effective.
  • 15 mg / 5 mL UNII JNJ23Q2COM
    Lysine hydrochloride is an amino acid salt used in medicines as a buffer and pH stabilizer. It helps maintain the acidity level of the product to keep the active ingredient stable and effective.
  • 170 mg / 5 mL UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • 4 mg / 5 mL UNII AE28F7PNPL
    Methionine is an amino acid used as a nutrient supplement and pH buffer in medicines. It helps stabilize the formulation and supports the product's overall composition.
  • 2 mg / 5 mL UNII 7A314HQM0I
    Pentetic acid is a chelating agent, a chemical that binds to metals. It's used in some medicines to prevent metal ions from interfering with drug stability or effectiveness.
  • .04 mg / 5 mL UNII 4VON5FNS3C
    Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.

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

LabelerMAIA Pharmaceuticals, Inc.
Application holderMAIA PHARMACEUTICALS INC
FDA applicationNDA210850 (NDA)
Labeler code70511
First marketedNov 2022
Product typeHuman Prescription Drug
Portfolio10 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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 196 words ▾

1 INDICATIONS AND USAGE Sincalide for Injection is indicated in adults to: stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract.

Sincalide for Injection is a cholecystokinin (CCK) analog indicated in adults to: • stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals. (1) • stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology. (1) • accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract.

(1)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended Adult Dosage and Administration by Indication: To Stimulate Contraction of the Gallbladder 0.02 mcg/kg as a single dose over 30 to 60 seconds via intravenous injection. If satisfactory contraction does not occur in 15 minutes, administer a dose of 0.04 mcg/kg over 30 to 60 seconds. (2.1) Alternatively consider an intravenous infusion to reduce gastrointestinal adverse reactions: 0.12 mcg/kg diluted in 100 mL of 0.9% Sodium Chloride Injection USP and infused over 50 minutes at a rate of 2 mL per minute.

(2.1, 2.2, 5.3) To Stimulate Pancreatic Secretion in Combination with Secretin 30 minutes after initiation of secretin for injection, administer 0.02 mcg/kg diluted in 30 mL of 0.9% Sodium Chloride Injection USP and infused over 30 minutes at a rate of 1 mL per minute. (2.1, 2.2) To Accelerate Transit of a Barium Meal Through the Small Intestine: After the barium meal is beyond the proximal jejunum, administer 0.04 mcg/kg over 30 to 60 seconds via intravenous injection. (2.1) If satisfactory transit of the barium meal has not occurred in 30 minutes, administer a second dose of 0.04 mcg/kg over 30 to 60 seconds.

(2.1) Alternatively consider an intravenous infusion to reduce gastrointestinal adverse reactions: 0.12 mcg/kg diluted in 100 mL 0.9% Sodium Chloride Injection USP and infused over 30 minutes. (2.1, 2.2, 5.3)

2.1Recommended Dosage and Administration Instructions The recommended dosage and administration of Sincalide for Injection by indication is shown in Table 1. For preparation instructions see Dosage and Administration (2.2) . Table 1: Recommended Adult Dosage and Administration of Sincalide for Injection by Treatment Indication Indication Recommended Adult Dosage and Administration of Sincalide for Injection To stimulate contraction of the gallbladder Sincalide for Injection 0.02 mcg/kg as a single dose over 30 to 60 seconds via intravenous injection.

If satisfactory contraction does not occur in 15 minutes, administer a dose of 0.04 mcg/kg over 30 to 60 seconds. Alternatively, Consider an Intravenous Infusion to Reduce Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.3)] : 0.12 mcg/kg diluted in 100 mL of 0.9% Sodium Chloride Injection USP and infused over 50 minutes at a rate of 2 mL per minute. To stimulate pancreatic secretion in combination with secretin for injection Secretin for Injection: 0.25 units/kg as intravenous infusion over 60 minutes Sincalide for Injection: 30 minutes after initiation of secretin infusion, administer Sincalide for Injection 0.02 mcg/kg diluted in 30 mL of 0.9% Sodium Chloride Injection USP and infused over 30 minutes at a rate of 1 mL per minute.

To accelerate the transit of a barium meal through the small intestine After the barium meal is beyond the proximal jejunum, administer Sincalide for Injection 0.04 mcg/kg over 30 to 60 seconds via intravenous injection. If satisfactory transit of the barium meal has not occurred in 30 minutes, administer a second dose of 0.04 mcg/kg over 30 to 60 seconds. Alternatively, Consider an Intravenous Infusion to Reduce Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.3)] : 0.12 mcg/kg diluted in 100 mL 0.9% Sodium Chloride Injection USP and infused over 30 minutes.

2.2Preparation Instructions For Intravenous Injection Reconstitute Sincalide for Injection aseptically by adding 5 mL of Sterile Water for Injection USP to the vial. Inspect the reconstituted solution visually for particulate matter and discoloration after reconstitution and prior to administration. Withdraw the prescribed dose of the reconstituted solution from the vial and administer as an intravenous injection over 30 to 60 seconds, as shown in Table 1.

Discard the unused portion. Store the reconstituted solution at room temperature. Discard after 8 hours .

For single use only; discard unused portion. For Intravenous Infusion Reconstitute Sincalide for Injection aseptically by adding 5 mL of Sterile Water… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 45 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: 5 mcg of sincalide as a lyophilized white to off-white cake or powder for reconstitution in a single-dose vial. For injection: 5 mcg of sincalide as a lyophilized cake or powder in a single-dose vial for reconstitution (3)

⛔ Contraindications 51 words ▾

4 CONTRAINDICATIONS Sincalide for Injection is contraindicated in patients with: a history of a hypersensitivity reaction to sulfites or sincalide. Serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock [see Warnings and Precautions (5.1), Adverse Reactions (6)]. intestinal obstruction. History of hypersensitivity to sulfites or sincalide. (4, 5.1) Intestinal obstruction. (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Anaphylaxis, Anaphylactic Shock and Other Serious Hypersensitivity Reactions : Contains sodium metabisulfite. Serious reactions may occur during or soon after administration. If symptoms occur, discontinue the drug.

(4, 5.1) Evacuation of Gallstones : Stimulation of gallbladder contraction in patients with small gallbladder stones could lead to the evacuation of the stones from the gallbladder, resulting in their lodging in the cystic duct or in the common bile duct. (5.2) Gastrointestinal Adverse Reactions with Intravenous Injection : Administration as an intravenous injection may cause transient nausea, vomiting, abdominal pain or cramping, dizziness or flushing. To reduce the risk of adverse reactions when used to simulate contraction of the gallbladder or accelerate transit of a barium meal through the small intestine, administer as an intravenous infusion over 50 or 30 minutes, respectively.

(2.1, 5.3) Preterm Labor or Spontaneous Abortion : Advise pregnant women of the potential risk for preterm labor and spontaneous abortion. (5.4, 8.1)

5.1Anaphylaxis, Anaphylactic Shock and Other Serious Hypersensitivity Reactions Contains sodium metabisulfite ​[see Description (11)], ​ a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

In postmarketing experience, anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported during and within one hour following administration of sincalide [see Adverse Reactions (6)]. Sincalide for Injection is contraindicated in patients with a history of hypersensitivity to sulfites. Due to the potential for anaphylaxis, appropriate medical support should be readily available when Sincalide for Injection is administered.

If anaphylaxis or other hypersensitivity reactions occur, immediately discontinue the infusion and initiate appropriate medical treatment. Observe patients closely during and after the infusion. Do not reinitiate Sincalide for Injection in patients who have experienced symptoms of hypersensitivity [see Contraindications (4)].

5.2Evacuation of Gallstones Stimulation of gallbladder contraction in patients with small gallbladder stones could lead to the evacuation of the stones from the gallbladder, resulting in their lodging in the cystic duct or in the common bile duct.

5.3Gastrointestinal Adverse Reactions with Intravenous Injection Administration of Sincalide for Injection as an intravenous injection may cause adverse reactions such as nausea, vomiting, abdominal pain or cramping, dizziness, and flushing [see Adverse Reactions (6)] . These reactions are generally transient. To reduce the risk of adverse reactions with intravenous injection when used to simulate contraction of the gallbladder or accelerate transit of a barium meal through the small intestine, administer Sincalide for Injection as an intravenous infusion over 50 or 30 minutes, respectively [see Dosage and Administration (2.1)].

5.4Preterm Labor or Spontaneous Abortion Based on limited human data and mechanism of action, advise pregnant patients that Sincalide for Injection may cause preterm labor or spontaneous abortion [see Use in Specific Populations (8.1)].

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: • Anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions [see Warnings and Precautions (5.1)] • Evacuation of gallstones [see Warnings and Precautions (5.2)] • Adverse reactions with intravenous injection [see Warnings and Precautions (5.3)] • Preterm labor or spontaneous abortion [see Warnings and Precautions (5.4)] The following adverse reactions associated with the use of sincalide were identified in clinical trials or postmarketing reports.

Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. The most frequent adverse reactions (20% or greater) are gastrointestinal: abdominal discomfort or pain, and nausea; these may not necessarily indicate an abnormality of the biliary tract unless there is other clinical or radiologic evidence of disease. Less common adverse reactions include: Hypersensitivity reactions : anaphylaxis and anaphylactic shock, hypotension, throat tightness, bradycardia, shortness of breath, nausea, abdominal cramping, diaphoresis, hives, rash, itching; and numbness of face, lips and eyes [see Contraindications (4)] .

Neurological reactions : seizures, headache. Vasovagal reactions : dizziness, loss of consciousness, nausea, diaphoresis, syncope and hypotension (generally self-limiting). Other : nausea, vomiting, flushing, hypertension, urge to defecate, diarrhea, sneezing.

Most common adverse reactions (≥20%) are: abdominal discomfort or pain, and nausea. (6) To report SUSPECTED ADVERSE REACTIONS, contact MAIA Pharmaceuticals at 1-888-877-9064 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 84 words ▾

7 DRUG INTERACTIONS Drugs that Affect Gallbladder Motility or Contractile Response : May interfere with response to sincalide. Consider discontinuing these drugs prior to administration of Sincalide for Injection, when used to stimulate contraction of the gallbladder. (7.1)

7.1Drugs that Affect Gallbladder Motility or Contractile Response Drugs that may stimulate or inhibit gallbladder motility or contractile response, may interfere with the response to sincalide. Consider discontinuing these drugs prior to administration of Sincalide for Injection, when used to simulate contraction of the gallbladder.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Based on limited human data and mechanism of action, Sincalide for Injection may cause preterm labor or spontaneous abortion [see Warnings and Precautions (5.4)]. Limited available data with Sincalide for Injection are insufficient to inform a drug-associated risk of adverse developmental outcomes. In animal embryo-fetal development studies in which sincalide was administered to hamsters and rats during the period of organogenesis, no effects were seen at doses comparable to the maximum recommended clinical dose on a mg/kg basis.

However, in a prenatal development study in which rats were administered sincalide during organogenesis through parturition, decreased weight gain and developmental delays were observed at a dose 122 times higher than the maximum recommended human dose based on body surface area. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data There were no effects on embryo-fetal development in hamsters when sincalide was administered subcutaneously at 250 or 750 ng/kg during organogenesis (Gestation Days 7 to 13) at doses up to 0.8 times the maximum recommended dose of 120 ng/kg on a body surface area basis. No effects on embryo-fetal development were observed in Sprague-Dawley rats at subcutaneous doses of 250, 450, or 750 ng/kg from Gestation Days 6 to16, representing 1.0 time the maximum recommended human dose on a body surface area basis.

In a separate study at a higher dose of 90 mcg/kg administered subcutaneously to CFY rats from Gestation Day 10 through parturition (representing 122 times the maximum recommended human dose on a body surface area basis), offspring showed decreased growth, behavioral changes, and developmental delays.

8.2Lactation Risk Summary There are no data regarding the presence of sincalide in human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Sincalide for Injection and any potential adverse effect on the breastfed infant from Sincalide for Injection or from the underlying condition.

8.4Pediatric Use The safety and effectiveness in pediatric patients have not been established. Animal Data Direct injection of sincalide in neonatal rats reduced milk consumption with the youngest rats exhibiting the greatest sensitivity to this effect. Although safety margins relative to maternal doses cannot be calculated since rat pups were injected directly, the safety margin in the youngest rat pups was less than 0.1 on a body surface area bases compared to the maximum adult clinical dose.

At higher doses administered subcutaneously in neonatal rats, transient behavioral changes and small effects on physical developmental milestones such as ear opening, eye opening, and incisor appearance were observed (at doses 10 to 200-fold higher than the maximum recommended human dose on a body surface area basis).

8.5Geriatric Use Clinical studies of sincalide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Based on limited human data and mechanism of action, Sincalide for Injection may cause preterm labor or spontaneous abortion [see Warnings and Precautions (5.4)]. Limited available data with Sincalide for Injection are insufficient to inform a drug-associated risk of adverse developmental outcomes. In animal embryo-fetal development studies in which sincalide was administered to hamsters and rats during the period of organogenesis, no effects were seen at doses comparable to the maximum recommended clinical dose on a mg/kg basis.

However, in a prenatal development study in which rats were administered sincalide during organogenesis through parturition, decreased weight gain and developmental delays were observed at a dose 122 times higher than the maximum recommended human dose based on body surface area. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data There were no effects on embryo-fetal development in hamsters when sincalide was administered subcutaneously at 250 or 750 ng/kg during organogenesis (Gestation Days 7 to 13) at doses up to 0.8 times the maximum recommended dose of 120 ng/kg on a body surface area basis. No effects on embryo-fetal development were observed in Sprague-Dawley rats at subcutaneous doses of 250, 450, or 750 ng/kg from Gestation Days 6 to16, representing 1.0 time the maximum recommended human dose on a body surface area basis.

In a separate study at a higher dose of 90 mcg/kg administered subcutaneously to CFY rats from Gestation Day 10 through parturition (representing 122 times the maximum recommended human dose on a body surface area basis), offspring showed decreased growth, behavioral changes, and developmental delays.

🧒 Pediatric Use 125 words ▾

8.4Pediatric Use The safety and effectiveness in pediatric patients have not been established. Animal Data Direct injection of sincalide in neonatal rats reduced milk consumption with the youngest rats exhibiting the greatest sensitivity to this effect. Although safety margins relative to maternal doses cannot be calculated since rat pups were injected directly, the safety margin in the youngest rat pups was less than 0.1 on a body surface area bases compared to the maximum adult clinical dose.

At higher doses administered subcutaneously in neonatal rats, transient behavioral changes and small effects on physical developmental milestones such as ear opening, eye opening, and incisor appearance were observed (at doses 10 to 200-fold higher than the maximum recommended human dose on a body surface area basis).

🧓 Geriatric Use 27 words ▾

8.5Geriatric Use Clinical studies of sincalide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🆘 Overdosage 113 words ▾

10 OVERDOSAGE In the event of an overdose, symptoms related to vagal stimulation, such as gastrointestinal symptoms (abdominal cramps, nausea, vomiting and diarrhea), hypotension with dizziness or fainting may occur. Overdosage symptoms should be treated symptomatically and should be of short duration. A single bolus intravenous injection of 0.05 mcg/kg (approximately 2 to 3 times the human dose of 0.02 mcg/kg), sincalide caused hypotension and bradycardia in dogs.

In addition, higher doses injected intravenously once or repeatedly in dogs caused syncope and ECG changes (approximately 5 times the human dose of 0.02 mcg/kg). These effects were attributed to sincalide-induced vagal stimulation in that all were prevented by pretreatment with atropine or bilateral vagotomy.

🧬 Clinical Pharmacology 130 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action When injected intravenously, Sincalide stimulates gallbladder contraction and reduction in size. The evacuation of bile that results is similar to that which occurs physiologically in response to endogenous cholecystokinin. Sincalide also stimulates pancreatic secretion and intestinal motility causing pyloric contraction and slows gastric emptying.

Concurrent administration of sincalide with secretin increases both the volume of pancreatic secretion and the output of bicarbonate and enzymes. This combined effect of secretin and sincalide permits the assessment of specific pancreatic function through measurement and analysis of the duodenal aspirate.

12.2Pharmacodynamics Following an intravenous (bolus) injection of 0.02 mcg/kg sincalide, maximal contraction of the gallbladder occurred in 5 to 15 minutes. Sincalide reduced gallbladder radiographic size by at least 40%, which is generally considered satisfactory contraction.

🧬 Mechanism of Action 90 words ▾

12.1Mechanism of Action When injected intravenously, Sincalide stimulates gallbladder contraction and reduction in size. The evacuation of bile that results is similar to that which occurs physiologically in response to endogenous cholecystokinin. Sincalide also stimulates pancreatic secretion and intestinal motility causing pyloric contraction and slows gastric emptying.

Concurrent administration of sincalide with secretin increases both the volume of pancreatic secretion and the output of bicarbonate and enzymes. This combined effect of secretin and sincalide permits the assessment of specific pancreatic function through measurement and analysis of the duodenal aspirate.

📦 How Supplied / Storage and Handling 59 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Sincalide for Injection is supplied as 5 mcg of sincalide as a lyophilized white to off-white cake or powder for reconstitution in a single-dose vial; in packages of 10 vials (NDC 70511-131-05). Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

📋 Description 93 words ▾

11 DESCRIPTION Sincalide for Injection is a cholecystopancreatic-gastrointestinal hormone for parenteral administration. The agent is a synthetically-prepared C-terminal octapeptide of cholecystokinin. Each single-dose vial of sincalide provides a sterile nonpyrogenic lyophilized white to off-white cake or powder consisting of 5 mcg sincalide with 30 mg arginine hydrochloride, 15 mg lysine hydrochloride,170 mg mannitol, 4 mg methionine, 2 mg pentetic acid, and 0.04 mg sodium metabisulfite.

The pH is adjusted to 6.5 to 7.5 with hydrochloric acid and/or sodium hydroxide prior to lyophilization. Sincalide is designated chemically as L-α-aspartyl-O- sulfo-L-tyrosyl-L-methionylglycyl-L-tryptophyl-L-methionyl- L-α-aspartyl-L-phenylalaninamide. Graphic formula: sincalide-structure

💬 Information for Patients 124 words ▾

17 PATIENT COUNSELING INFORMATION Anaphylaxis, Anaphylactic Shock and Other Serious Hypersensitivity Reactions Inform patients serious hypersensitivity reactions, including anaphylaxis and anaphylactic shock have been reported during or following administration of Sincalide for Injection. Advise patients to report immediately to a healthcare provider if they experience symptoms of a hypersensitivity reaction [see Warnings and Precautions (5.1)]. Gastrointestinal Adverse Reactions Advise patients that Sincalide for Injection may cause transient gastrointestinal symptoms [see Warnings and Precautions (5.3)].

Pregnancy Advise pregnant women of the potential risk for preterm labor and spontaneous abortion [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)]. Manufactured for: MAIA Pharmaceuticals, Inc. 707 State Road, Suite #104 Princeton, NJ 08540 USA Manufactured by: Gland Pharma Limited Hyderabad, 500 043, India Manufactured in India

🧬 Pharmacodynamics 37 words ▾

12.2Pharmacodynamics Following an intravenous (bolus) injection of 0.02 mcg/kg sincalide, maximal contraction of the gallbladder occurred in 5 to 15 minutes. Sincalide reduced gallbladder radiographic size by at least 40%, which is generally considered satisfactory contraction.

🧪 Nonclinical Toxicology 32 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic or mutagenic potential, or possible impairment of fertility in males or females.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 29 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic or mutagenic potential, or possible impairment of fertility in males or females.

📄 Recent Major Changes 16 words ▾

Contraindications (4) 10/2023 Warnings and Precautions, Anaphylaxis, Anaphylactic Shock and other Serious Hypersensitvity Reactions (5.1) 10/2023

📄 Package Label / Principal Display Panel 78 words ▾

Principal Display Panel NDC 70511-131-05 Sincalide for Injection 5 mcg/vial For Intravenous Use Vial contains a sterile, lyophilized powder providing 5 mcg sincalide (see insert for inactive ingredients); pH adjusted to 6.5 to 7.5 with hydrochloric acid and/or sodium hydroxide. Recommended Dosage: See Prescribing Information Single-Dose Vial. Discard Unused Portion.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature] Manufactured for MAIA Pharmaceuticals, Inc. vial

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

About this NDC listing & data coverage

Finished prescription product
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) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 MAIA Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
MAIA Pharmaceuticals, Inc. 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.
← 70511-0124-10 · MAIA 70511-0142-50 · MAIA →
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.