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Glucagon 1 mg/mL Injection, Powder, Lyophilized, For Solution, 10 vials — NDC 63323-0596-16 package photo

Glucagon 1 mg/mL Injection, Powder, Lyophilized, For Solution, 10 vials

by Fresenius Kabi USA, LLC · 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-596-16) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-596-08)
NDC 63323-0596-16
🏷️ FDA NDC (as labeled) 63323-596-16 billing pads the product segment with a zero
This package
Contains10 vials Pack sizes2 compare ↓
Also priced by: Part D plans $213.35/unit — full pricing hub ↓
Also comes in: 10 vials 63323-0596-13
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 17, 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 Glucagon (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 — CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing. (Lupin Pharmaceuticals Inc.) · FDA recall D-0723-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 63323-596-16
Product NDC 63323-596
11-digit billing NDC 63323059616
NCPDP billing unit EA — each (per item)
RxCUI 310497
UNII 1H87NVF4DB
UPC 0363323596033
Application # NDA201849
SPL Set ID 8c8acad6-44cc-43aa-966b-027e053be8f5
Established class (EPC) Antihypoglycemic Agent; Gastrointestinal Motility Inhibitor
Physiologic effect Decreased GI Motility; Decreased GI Smooth Muscle Tone; Decreased Glycolysis; Increased Gluconeogenesis; Increased Glycogenolysis
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-05-08
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance GLUCAGON HYDROCHLORIDE
GPI-14 94200041052110
GPI class Glucagon HCl (Diagnostic)
GCN Seq No 074063
GCN 38585
HICL code 017284
Ingredient (HICL) Glucagon Hcl
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z9
Therapeutic class — intermediate (HIC2) Unclassified Drugs
HIC3 code Z9D
Therapeutic class — specific (HIC3) Diagnostic Preparations,Miscellaneous
AHFS code 36:00.00.00
AHFS class Diagnostic Agents
FDB label name GLUCAGON 1 MG VIAL
FDB brand name Glucagon Hcl
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 63323-596-16 — 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 → 63323-0596-16. 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 Antihypoglycemic Agent class.

Pharmacologic class Antihypoglycemic Agent, Gastrointestinal Motility Inhibitor
Drug family (ATC) Glycogenolytic hormones
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.

🏭 Manufacturer & labeler

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationNDA201849 (NDA)
Labeler code63323
First marketedMay 2015
Product typeHuman Prescription Drug
Portfolio554 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name GLUCAGON 1 MG VIAL Ingredient Glucagon Hcl
📖 What it is MedlinePlus · NLM

Glucagon injection is used for emergency treatment of very low blood sugar (severe hypoglycemia). It is also used to slow down movement in the digestive system during certain X-ray lab tests. Glucagon is in a class of medications called glycogenolytic agents. It works by causing the liver to release stored sugar to the blood. It also works by relaxing digestive muscles for X-ray lab testing.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Glucagon injection is an emergency treatment for severe low blood sugar — the kind where someone with diabetes is unconscious, having a seizure, or can't swallow anything safely. I...
  • What is glucagon injection used for, and when would I actually need it?
  • Your liver stores sugar in a form called glycogen, kind of like a backup fuel tank. Glucagon tells the liver to break that stored sugar down and release it into the bloodstream, ra...
  • How does glucagon injection actually work to raise blood sugar?
📖 Read our full Glucagon Injection guide →
1
Nutrient depletion considerations

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

🧪 Full Glucagon nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

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

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

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

3 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.

💲 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 · Q2 2026 $213.35 $2,133.46 / 10 ml
Medicare Part B allowsASP · J1611 $129.281 / J1611 unit —
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.

🧾 Billing & reimbursement

FDA NDC (as labeled)63323-596-16
11-digit billing NDC63323-0596-16
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1611
DescriptorInjection, glucagon hydrochloride (fresenius kabi), not therapeutically equivalent to j1610, per 1 mg
Billing units / pkg10 units
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Glucagon 00378-8067-90 Mylan 1 kit $160.531 AP Availability likely —
Glucagon 00548-5850-00 Amphastar 1 kit $160.531 AP Availability likely —
Glucagon 69097-0027-50 Cipla 1 kit $160.531 AP Availability likely —
Glucagon 70748-0311-01 Lupin 1 kit $160.531 AP Availability likely —
Glucagon 63323-0582-82 Fresenius 1 kit $239.209 — Availability likely —
Glucagon 50090-6550-00 A-S 1 kit — AP FDA listed —
Glucagon 51662-1498-01 HF 1 kit — — FDA listed —
Glucagon 63323-0593-03 Fresenius 1 kit — — FDA listed —
Glucagon 63323-0594-03 Fresenius 1 kit — — FDA listed —
Glucagon 1 mg/mLthis 63323-0596-16 Fresenius 10 vials — — FDA listed —
Glucagon 85766-0043-01 Sportpharm 1 kit — AP FDA listed —
Glucagon 85766-0065-01 Sportpharm 1 kit — 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

🏛️
2015
On the market since
May 2015
📍
2026
Currently FDA-listed
11 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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
10 vials63323-0596-13 60 Rx · $22,013
10 vials this page63323-0596-16 No Medicaid data
Drug total (last 4 qtrs): 60 Rx · 63 units · $22,013 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Gvoke Hypopen 2-Pack (matched by generic name) — 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 Gvoke Hypopen 2-Pack. CMS lists 8 products for this generic; we show the highest-spend one. 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
$9.75M
Claims incl. refills
14.2K
Beneficiaries
11.8K
Spend / beneficiary
$825.37
Spend / claim
$687.38
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
63323-0596-16 You're viewing this 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-596-16) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-596-08) 2015-05-08 Active
63323-0596-13 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-596-13) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-596-11) 2015-05-08 Active

Pack size FAQ

What quantity is in NDC 63323-0596-16?
NDC 63323-0596-16 contains 10 vials — 10 vial, single-dose in 1 tray / 1 ml in 1 vial, single-dose.
What is the difference between NDC 63323-0596-16 and NDC 63323-0596-13?
Both are Glucagon 1 mg/mL Injection, Powder, Lyophilized, For Solution — the drug itself is identical. NDC 63323-0596-16 is the 10 vials package, while NDC 63323-0596-13 is the 10 vials package.
What NDC number is used to bill for this package of Glucagon 1 mg/mL Injection, Powder, Lyophilized, For Solution?
Bill NDC 63323-0596-16 — the 11-digit billing format is 63323059616. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 — 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 ✓ Available
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 FDA registers it as 63323-596-16, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 63323-0596-16, written without dashes as 63323059616. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 63323-0596-16, the first segment (63323) is the labeler code FDA assigned to Fresenius Kabi USA, LLC; the middle segment (0596) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 10 vials (63323-0596-13). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Fresenius Kabi USA, LLC 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1611 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 114 words ▾

1 INDICATIONS AND USAGE Glucagon for Injection is indicated for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract. Limitations of Use : Glucagon for Injection is not indicated for the emergency treatment of hypoglycemia because it is not packaged with a syringe and diluent necessary for rapid preparation and administration during an emergency outside of a healthcare facility. Glucagon for Injection is a gastrointestinal motility inhibitor indicated for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal (GI) tract ( 1 ) Limitations of Use: Glucagon for Injection is not indicated for the emergency treatment of hypoglycemia ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Reconstitute lyophilized powder with Sterile Water for Injection before use ( 2.2 , 2.3 ) Determine dose based on diagnostic procedure, route of administration and procedure duration ( 2.1 ): To inhibit stomach and small bowel motility the dose is 0.2 mg to 0.5 mg given intravenously or 1 mg given intramuscularly To inhibit colon motility the dose is 0.5 mg to 0.75 mg given intravenously or 1 mg to 2 mg given intramuscularly

2.1Recommended Dose Determine the dose based on the type of diagnostic procedure, the route of administration and expected procedure duration [see Clinical Pharmacology ( 12.2 )] . The usual dose to inhibit movement of the: Stomach and small bowel is 0.2 mg to 0.5 mg given intravenously or 1 mg given intramuscularly. Colon is 0.5 mg to 0.75 mg given intravenously or 1 mg to 2 mg given intramuscularly.

Bolus doses above 1 mg administered intravenously have caused nausea and vomiting and are not recommended [see Adverse Reactions ( 6 )] .

2.2Reconstitution of the Lyophilized Powder Glucagon for Injection is a lyophilized powder, which requires reconstitution with Sterile Water for Injection prior to intravenous or intramuscular use. Using a syringe, withdraw 1 mL of Sterile Water for Injection and inject into the vial containing Glucagon for Injection lyophilized powder. Shake the vial gently until the powder is completely dissolved and no particles remain in the reconstituted solution.

Visually inspect the reconstituted solution for particulate matter and discoloration prior to administration. The reconstituted solution should be clear and of water-like consistency. Discard the reconstituted solution if there are signs of gel formation or particles.

The reconstituted solution has a concentration of approximately 1 mg of glucagon per mL. Use the reconstituted glucagon immediately after reconstitution.

2.3Important Administration Instructions Glucagon for Injection must be administered by medical personnel. The timing of administration of Glucagon for Injection depends upon the organ under examination and route of administration [see Clinical Pharmacology ( 12.2 )] . If given intravenously, administer Glucagon for Injection as a bolus over a time period of 1 minute.

Discard any unused portion. After the end of the diagnostic procedure, give oral carbohydrates to patients who have been fasting, if this is compatible with the diagnostic procedure.

2.1Recommended Dose Determine the dose based on the type of diagnostic procedure, the route of administration and expected procedure duration [see Clinical Pharmacology ( 12.2 )] . The usual dose to inhibit movement of the: Stomach and small bowel is 0.2 mg to 0.5 mg given intravenously or 1 mg given intramuscularly. Colon is 0.5 mg to 0.75 mg given intravenously or 1 mg to 2 mg given intramuscularly.

Bolus doses above 1 mg administered intravenously have caused nausea and vomiting and are not recommended [see Adverse Reactions ( 6 )] .

2.2Reconstitution of the Lyophilized Powder Glucagon for Injection is a lyophilized powder, which requires reconstitution with Sterile Water for Injection prior to intravenous or intramuscular use. Using a syringe, withdraw 1 mL of Sterile Water for Injection and inject into the vial containing Glucagon for Injection lyophilized powder. Shake the vial gently until the powder is completely dissolved and no particles remain in the reconstituted solution.

Visually inspect the reconstituted solution for particulate matter and discoloration prior to administration. The reconstituted solution should be clear and of water-like consistency. Discard the reconstituted solution if there are signs of gel formation or particles.

The reconstituted solution has a concentration of approximately 1 mg of glucagon per mL. Use the reconstituted glucagon immediately after reconstitution.

2.3Important Administration Instructions Glucagon for Injection must be administered by medical personnel. The timing of administratio…

💊 Dosage Forms and Strengths 33 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: 1 mg of lyophilized powder in single dose vial for reconstitution. For Injection: 1 mg lyophilized powder in single dose vial for reconstitution ( 3 )

⛔ Contraindications 72 words ▾

4 CONTRAINDICATIONS Glucagon for Injection is contraindicated in patients with: Pheochromocytoma [see Warnings and Precautions ( 5.1 )] because of the risk of increased blood pressure Insulinoma [see Warnings and Precautions ( 5.2 )] because of the risk of hypoglycemia Glucagonoma [see Warnings and Precautions ( 5.2 )] because of the risk of hypoglycemia Pheochromocytoma ( 4 , 5.1 ) Insulinoma ( 4 , 5.2 ) Glucagonoma ( 4 , 5.2 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hyperglycemia in patients with diabetes : Monitor blood glucose and treat with insulin if indicated ( 5.3 ) Increased blood pressure and heart rate in patients with cardiac disease : Monitor patients with known cardiac disease ( 5.4 ) Allergic reactions including anaphylactic shock with breathing difficulties, and hypotension, generalized rash : Discontinue and treat as indicated ( 5.5 )

5.1Hypertension in Patients with Pheochromocytoma Glucagon for Injection is contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor, which may result in a sudden and marked increase in blood pressure.

5.2Hypoglycemia in Patients with Insulinoma or Glucagonoma Glucagon for Injection is contraindicated in patients with insulinoma or glucagonoma as it may cause secondary hypoglycemia. Test patients suspected of having glucagonoma for blood levels of glucagon prior to treatment, and monitor for changes in blood glucose levels during treatment. If a patient develops symptoms of hypoglycemia after a dose of Glucagon for Injection, administer glucose orally or intravenously.

5.3Hyperglycemia in Patients with Diabetes Mellitus Treatment with Glucagon for Injection in patients with diabetes mellitus may cause hyperglycemia. Monitor diabetic patients for changes in blood glucose levels during treatment. If patients develop symptoms of hyperglycemia after a dose of Glucagon for Injection, administer insulin.

5.4Blood Pressure and Heart Rate Increase in Patients with Cardiac Disease Glucagon for Injection may increase myocardial oxygen demand, blood pressure, and pulse rate which may be life-threatening in patients with cardiac disease. Cardiac monitoring is recommended in patients with cardiac disease during glucagon treatment, and an increase in blood pressure and pulse rate may require therapy.

5.5Hypersensitivity and Allergic Reactions Generalized allergic reactions and hypersensitivity, including generalized rash, and anaphylactic shock with breathing difficulties, and hypotension, have been reported with glucagon treatment or lactose. Discontinue Glucagon for Injection and administer standard treatment for anaphylaxis if needed.

5.1Hypertension in Patients with Pheochromocytoma Glucagon for Injection is contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor, which may result in a sudden and marked increase in blood pressure.

5.2Hypoglycemia in Patients with Insulinoma or Glucagonoma Glucagon for Injection is contraindicated in patients with insulinoma or glucagonoma as it may cause secondary hypoglycemia. Test patients suspected of having glucagonoma for blood levels of glucagon prior to treatment, and monitor for changes in blood glucose levels during treatment. If a patient develops symptoms of hypoglycemia after a dose of Glucagon for Injection, administer glucose orally or intravenously.

5.3Hyperglycemia in Patients with Diabetes Mellitus Treatment with Glucagon for Injection in patients with diabetes mellitus may cause hyperglycemia. Monitor diabetic patients for changes in blood glucose levels during treatment. If patients develop symptoms of hyperglycemia after a dose of Glucagon for Injection, administer insulin.

5.4Blood Pressure and Heart Rate Increase in Patients with Cardiac Disease Glucagon for Injection may increase myocardial oxygen demand, blood pressure, and pulse rate which may be life-threatening in patients with cardiac disease. Cardiac monitoring is recommended in patients with cardiac disease during glucagon treatment, and an increase in blood pressure and pulse rate may require therapy.

5.5Hypersensitivity and Allergic Reactions Generalized allergic reactions and hypersensitivity, including generalized rash, and anaphylactic shock with breathing difficulties, and hypotension, have been reported with glucagon treatment or lactose. Discontinue Gluca…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Hypertension in patients with Pheochromocytoma [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] Hypoglycemia in Patients with Insulinoma and Glucagonoma [see Contraindications ( 4 ) and Warnings and Precautions ( 5.2 )] Hyperglycemia in Patients with Diabetes Mellitus [see Warnings and Precautions ( 5.3 )] Hypersensitivity and Allergic Reactions; generalized allergic reactions including generalized rash, and in some cases anaphylactic shock with breathing difficulties, and hypotension [see Warnings and Precautions ( 5.5 )] Adverse Reactions from Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in clinical trials of another drug and may not reflect the rates observed in practice.

In an open-label clinical study of Glucagon for Injection, 29 healthy volunteers received a single dose of 1 mg Glucagon for Injection intramuscularly. Table 1 shows the most common adverse reactions that were not present at baseline and occurred in at least 5% of patients. Table 1: Adverse Reactions in Healthy Volunteers Who Received Glucagon for Injection, 1 mg Administered Intramuscularly (N=29) % of Patients Vomiting 17 Nausea 7 Adverse Reactions from the Literature and Other Clinical Studies The following adverse reactions have been identified from the literature and clinical studies with the use of glucagon.

Therefore, it is not possible to reliably estimate their frequency. Nausea and vomiting occurred with doses above 1 mg administered by rapid intravenous injection (within 1 to 2 seconds) . Doses above 1 mg are not recommended for intravenous use [see Dosage and Administration ( 2.1 )].

Hypotension was reported up to 2 hours after administration in patients receiving glucagon as premedication for upper GI endoscopy procedures. A temporary increase in both blood pressure and pulse rate occurred following the administration of glucagon. Patients taking beta-blockers experienced a temporary increase in both pulse and blood pressure that was greater than normal [see Drug Interactions ( 7 )] .

Other adverse reactions included hypoglycemia and hypoglycemic coma, as described in postmarketing reports. Patients taking indomethacin may be more likely to experience hypoglycemia following glucagon administration [see Drug Interactions ( 7 )] . Adverse reactions seen with glucagon are transient changes in blood pressure, increase in heart rate, hypersensitivity reactions, nausea and vomiting, and hypoglycemia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Table 2 includes clinically significant drug interactions with Glucagon for Injection. Table 2: Clinically Significant Drug Interactions with Glucagon for Injection Beta-Blockers Clinical Impact: The concomitant use of beta-blockers and Glucagon for Injection may increase the risk of a temporary increase in heart rate and blood pressure. Intervention: The increase in blood pressure and heart rate may require therapy in patients with coronary artery disease.

Insulin Clinical Impact: Insulin reacts antagonistically towards glucagon. Intervention: Monitor blood glucose when Glucagon for Injection is used as a diagnostic aid in diabetes patients. Indomethacin Clinical Impact: The concomitant use of indomethacin and Glucagon for Injection may lead to hypoglycemia.

Intervention: Monitor blood glucose levels during glucagon treatment of patients taking indomethacin. Anticholinergic Drugs Clinical Impact: The concomitant use of anticholinergic drugs and Glucagon for Injection increase the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility. Intervention: Concomitant use is not recommended.

Warfarin Clinical Impact: Glucagon may increase the anticoagulant effect of warfarin. Intervention: Monitor patients for unusual bruising or bleeding, as adjustments in warfarin dosage may be required. Beta-blockers : May cause a greater increase in both heart rate and blood pressure ( 7 ) Insulin : Reacts antagonistically towards glucagon; monitor glucose ( 7 ) Indomethacin : May produce hypoglycemia; monitor glucose ( 7 ) Anticholinergic Drugs : Concomitant use not recommended due to increased gastrointestinal adverse reactions ( 7 ) Warfarin : May increase anticoagulant effect of warfarin; may require an adjustment in warfarin dosage ( 7 )

👥 Use in Specific Populations 207 words ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Category B. Reproduction studies were performed in rats and rabbits with another glucagon product at doses of 0.4, 2, and 10 mg per kg. These doses represent exposures of up to 100 and 200 times the human dose based on mg/m 2 for rats and rabbits, respectively, and revealed no evidence of harm to the fetus.

There are, however, no adequate and well-controlled studies in pregnant women. Glucagon does not cross the human placental barrier.

8.3Nursing Mothers It is not known whether glucagon is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when glucagon is administered to a nursing woman. No clinical studies have been performed in nursing mothers, however, glucagon is a peptide and intact glucagon is not absorbed from the GI tract.

Therefore, even if the infant ingested glucagon it would be unlikely to have any effect on the infant. Additionally, glucagon has a short plasma half-life thus limiting amounts available to the child.

8.4Pediatric Use Safety and effectiveness of Glucagon for Injection have not been established in pediatric patients for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract.

🤰 Pregnancy 78 words ▾

8.1Pregnancy Pregnancy Category B. Reproduction studies were performed in rats and rabbits with another glucagon product at doses of 0.4, 2, and 10 mg per kg. These doses represent exposures of up to 100 and 200 times the human dose based on mg/m 2 for rats and rabbits, respectively, and revealed no evidence of harm to the fetus.

There are, however, no adequate and well-controlled studies in pregnant women. Glucagon does not cross the human placental barrier.

🧒 Pediatric Use 34 words ▾

8.4Pediatric Use Safety and effectiveness of Glucagon for Injection have not been established in pediatric patients for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract.

🆘 Overdosage 65 words ▾

10 OVERDOSAGE If overdosage occurs, the patient may experience nausea, vomiting, inhibition of GI tract motility, increase in blood pressure and heart rate, and decrease in serum potassium. In case of suspected overdosage, monitor and correct hypokalemia. If the patient develops a severe increase in blood pressure, phentolamine mesylate may be effective in lowering blood pressure for the short time that control would be needed.

🧬 Clinical Pharmacology 172 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Extra hepatic effects of glucagon include relaxation of the smooth muscle of the stomach, small bowel, and colon.

12.2Pharmacodynamics Table 3 displays the pharmacodynamics properties of Glucagon for Injection as a diagnostic aid during radiologic examination. Table 3: Pharmacodynamic Properties of Glucagon for Injection as a Diagnostic Aid Route of Administration Dose a Time of Onset of Action for GI Smooth Muscle Relaxation Duration of Smooth Muscle Relaxation Intravenous 0.25 to 0.5 mg 45 seconds 9 to 17 minutes Intramuscular 1 mg 8 to 10 minutes 12 to 27 minutes 2 mg 4 to 7 minutes 21 to 32 minutes a Select from these doses based on type of diagnostic procedure, route of administration and procedure duration.

12.3Pharmacokinetics Absorption Following intramuscular administration of 1 mg dose, the maximum plasma glucagon concentrations of 3391 pg/mL were attained approximately 10 minutes after dosing. Metabolism The mean apparent half-life of glucagon was 26 minutes after intramuscular administration. Glucagon is degraded in the liver, kidney, and plasma.

🧬 Mechanism of Action 22 words ▾

12.1Mechanism of Action Extra hepatic effects of glucagon include relaxation of the smooth muscle of the stomach, small bowel, and colon.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Glucagon for Injection is supplied as a sterile, lyophilized white powder in a vial. Presentation/ Product Code Unit of Sale NDC Strength Description/Unit of Use NDC 10 Single dose vials NP509613 63323-596-16 1 mg per vial 1 mL single dose vial of Glucagon for Injection (NDC 63323-596-08) Diagnostic Kit NP509603 63323-594-03 1 mg per vial 1 mL single dose vial of Glucagon for Injection (NDC 63323-596-06) with 1 mL single dose vial of Sterile Water for Injection, USP for reconstitution (NDC 63323-185-03) The container closure is not made with natural rubber latex.

16.2Recommended Storage Before Reconstitution The package containing Glucagon for Injection vials may be stored up to 24 months at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature] prior to reconstitution. Do not freeze. Keep in the original package to protect from light.

After Reconstitution The Glucagon for Injection must be reconstituted with Sterile Water for Injection prior to use. Use reconstituted glucagon solution immediately. Discard any unused portion [see Dosage and Administration ( 2.3 )] .

16.1How Supplied Glucagon for Injection is supplied as a sterile, lyophilized white powder in a vial. Presentation/ Product Code Unit of Sale NDC Strength Description/Unit of Use NDC 10 Single dose vials NP509613 63323-596-16 1 mg per vial 1 mL single dose vial of Glucagon for Injection (NDC 63323-596-08) Diagnostic Kit NP509603 63323-594-03 1 mg per vial 1 mL single dose vial of Glucagon for Injection (NDC 63323-596-06) with 1 mL single dose vial of Sterile Water for Injection, USP for reconstitution (NDC 63323-185-03) The container closure is not made with natural rubber latex.

16.2Recommended Storage Before Reconstitution The package containing Glucagon for Injection vials may be stored up to 24 months at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature] prior to reconstitution. Do not freeze. Keep in the original package to protect from light.

After Reconstitution The Glucagon for Injection must be reconstituted with Sterile Water for Injection prior to use. Use reconstituted glucagon solution immediately. Discard any unused portion [see Dosage and Administration ( 2.3 )] .

📋 Description 119 words ▾

11 DESCRIPTION Glucagon for Injection, for intravenous or intramuscular use, is a gastrointestinal motility inhibitor that is produced by solid phase peptide synthesis. Glucagon is a single-chain polypeptide containing 29 amino acid residues. The chemical structure of the glucagon polypeptide is identical to human glucagon and to glucagon extracted from beef and pork pancreas.

The structure of glucagon is: C 153 H 225 N 43 O 49 S Molecular Weight = 3483 Glucagon for Injection is a sterile, lyophilized white powder in a 3 mL vial. The reconstituted solution contains 1 mg of glucagon as hydrochloride per mL and lactose monohydrate (107 mg). Glucagon for Injection is supplied at pH 2.5 to 3.5 and is soluble in water. structure

💬 Information for Patients 170 words ▾

17 PATIENT COUNSELING INFORMATION Inform patients that generalized allergic reactions have been reported with glucagon treatment including generalized rash, and in some cases anaphylactic shock with breathing difficulties, and hypotension. Advise patients to monitor and report any signs or symptoms of a hypersensitivity reaction [ see Warnings and Precautions ( 5.5 )] . Inform patients that hypoglycemia has occurred with treatment with glucagon.

Inform patients of the symptoms of hypoglycemia and how to treat it. Advise patients to avoid driving or operating machinery until ingesting a meal. Advise patients to inform their health care provider if hypoglycemia occurs so that treatment may be given if necessary [ see Adverse Reactions ( 6 )] .

Inform patients with diabetes mellitus that treatment with Glucagon for Injection may increase their risk of hyperglycemia [see Warnings and Precautions ( 5.3 )]. Inform patients with cardiac disease that treatment with Glucagon for Injection may increase their risk of a transient increase in blood pressure and heart rate [see Warnings and Precautions ( 5.4 )].

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