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Glucagon Kit — NDC 63323-0582-82 package photo

Glucagon Kit

by Fresenius Kabi USA, LLC · 1 KIT in 1 KIT (63323-582-82) * 1 mL in 1 VIAL, SINGLE-DOSE (63323-583-13) * 1 mL in 1 SYRINGE, GLASS (63323-185-82)
NDC 63323-0582-82
🏷️ FDA NDC (as labeled) 63323-582-82 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for 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) 63323-582-82
Product NDC 63323-582
11-digit billing NDC 63323058282
NCPDP billing unit EA — each (per item)
RxCUI 310497
UPC 0363323583132
Application # NDA201849
SPL Set ID c5c431b4-5618-4ff4-954e-4c0fbfed67b6
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-09-09
Dosage form KIT
GPI-14 27300010202105
GPI class Glucagon Emergency
GCN Seq No 037671
GCN 08257
HICL code 017284
Ingredient (HICL) Glucagon Hcl
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M4
Therapeutic class — intermediate (HIC2) Affect Blood Lipids/Sugar/Amino Acids
HIC3 code M4G
Therapeutic class — specific (HIC3) Agents To Treat Hypoglycemia (Hyperglycemics)
AHFS code 68:22.12.00
AHFS class Glycogenolytic Agents
FDB label name GLUCAGON 1 MG EMERGENCY KIT
FDB brand name Glucagon Emergency Kit
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 63323-582-82 — 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 → 63323-0582-82. 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 marketedSep 2019
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 EMERGENCY KIT 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 ↗
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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $239.209 —
Medicaid paysCMS SDUD · 12 mo $262.64 —
Medicare drug plans payPart D · Q2 2026 $213.35 —
Medicare Part B allowsASP · J1611 $129.281 / J1611 unit —
NADAC price history (per ea) — tap or hover for the price & month
Aug 2021 Feb 2026 May 2026 Aug 2026 $239.271 $210.016
▲ Up 14% over the last 10 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.

🧾 Billing & reimbursement

FDA NDC (as labeled)63323-582-82
11-digit billing NDC63323-0582-82
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 / pkg1 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 save 33%
Glucagon 00548-5850-00 Amphastar 1 kit $160.531 AP Availability likely save 33%
Glucagon 69097-0027-50 Cipla 1 kit $160.531 AP Availability likely save 33%
Glucagon 70748-0311-01 Lupin 1 kit $160.531 AP Availability likely save 33%
Glucagonthis 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/mL 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 —
Glucagon 85766-0241-01 Sportpharm 1 kit — AP FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be 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

🏛️
2019
On the market since
Sep 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

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

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

🗺️ 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 63323-0582-82, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.8K
Units reimbursed last 4 qtrs
2.2K
Gross reimbursed last 4 qtrs
$584.1K
Avg / prescription
$319.19
Avg / unit
$262.62
Latest quarter Q4 2025
391Rx
Medicaid pays / ea
$262.62
gross reimbursed
vs
NADAC / ea
$239.21
acquisition cost
=
Spread
+$23.4086
+10% vs cost
What Medicaid paid per ea (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 ⓘ
52% FFS 48% MCO
Fee-for-service · 947 Rx Managed care · 883 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 30 units · 0.4 per 100k residents WA Idaho: 39 units · 2.0 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 13 units · 0.2 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 522 units · 2.7 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 31 units · 1.0 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 31 units · 0.2 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 113 units · 0.9 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 358 units · 0.9 per 100k residents CA Utah: no data reported UT Colorado: 86 units · 1.5 per 100k residents CO Nebraska: no data reported NE Missouri: 104 units · 1.7 per 100k residents MO Kentucky: 264 units · 5.8 per 100k residents KY West Virginia: no data reported WV Virginia: 81 units · 0.9 per 100k residents VA Maryland: 14 units · 0.2 per 100k residents 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: 79 units · 1.1 per 100k residents TN North Carolina: 91 units · 0.8 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: 246 units · 2.2 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 122 units · 0.4 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.25.8
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Kentucky 5.8 /100k
2 New York 2.7 /100k
3 Georgia 2.2 /100k
4 Idaho 2.0 /100k
5 Missouri 1.7 /100k
6 Colorado 1.5 /100k
7 Tennessee 1.1 /100k
8 Nevada 1.0 /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 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
63323-0582-82 You're viewing this 1 KIT in 1 KIT (63323-582-82) * 1 mL in 1 VIAL, SINGLE-DOSE (63323-583-13) * 1 mL in 1 SYRINGE, GLASS (63323-185-82) 2019-09-09 Active

🧭 About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data — 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) ✓ 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 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 63323-582-82, 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: 63323-0582-82, written without dashes as 63323058282. 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 63323-0582-82, the first segment (63323) is the labeler code FDA assigned to Fresenius Kabi USA, LLC; the middle segment (0582) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (82) 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.
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 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 105 words ▾

1 INDICATIONS AND USAGE Glucagon for Injection is an antihypoglycemic agent and a gastrointestinal motility inhibitor indicated: for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ( 1.1 ) as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients ( 1.2 )

1.1Severe Hypoglycemia Glucagon for Injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes.

1.2Diagnostic Aid Glucagon for Injection is indicated as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Dosage in adults and pediatric patients using the glucagon emergency kit for low blood sugar to treat severe hypoglycemia ( 2.2 ) Adults and Pediatric Patients Weighing More Than 25 kg or for Pediatric Patients with Unknown Weight 6 Years and Older: - The recommended dosage is 1 mg (1 mL) injected subcutaneously or intramuscularly into the upper arm, thigh, or buttocks, or intravenously. - If there has been no response after 15 minutes, an additional 1 mg dose (1 mL) of Glucagon for Injection may be administered using a new kit while waiting for emergency assistance.

Pediatric Patients Weighing Less Than 25 kg or for Pediatric Patients with Unknown Weight Less Than 6 Years of Age: - The recommended dosage is 0.5 mg (0.5 mL) injected subcutaneously or intramuscularly into the upper arm, thigh, or buttocks, or intravenously. - If there has been no response after 15 minutes, an additional 0.5 mg dose (0.5 mL) of Glucagon for Injection may be administered using a new kit while waiting for emergency assistance. Important Administration Instructions for Using the Glucagon Emergency Kit for Low Blood Sugar to Treat Severe Hypoglycemia ( 2.1 ) Glucagon for Injection is for subcutaneous, intramuscular, or intravenous injection.

Administer intravenously ONLY under medical supervision. See the Full Prescribing Information for administration instructions Dosage in Adults for Using Glucagon for Injection Diagnostic Kit and Glucagon for Injection Single-Dose Vial as a Diagnostic Aid ( 2.4 ) The recommended diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum, and small bowel is 0.2 mg to 0.5 mg administered intravenously or 1 mg administered intramuscularly; the recommended dose to relax the colon is 0.5 mg to 0.75 mg administered intravenously or 1 mg to 2 mg administered intramuscularly.

See the Full Prescribing Information for administration instructions ( 2.3 )

2.1Important Administration Instructions for Using the Glucagon Emergency Kit for Low Blood Sugar to Treat Severe Hypoglycemia Glucagon for Injection is for subcutaneous, intramuscular, or intravenous injection. Administer intravenously ONLY under medical supervision. Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia.

Because severe hypoglycemia requires the help of others to recover, instruct the patient to inform those around them about Glucagon for Injection and its Instructions for Use. Administer Glucagon for Injection as soon as possible when severe hypoglycemia is recognized. Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for Glucagon for Injection.

Emphasize the following instructions to the patient or caregiver: Using the supplied prefilled syringe, carefully insert the needle through the rubber stopper of the vial containing Glucagon for Injection powder and inject all the liquid from the syringe into the vial. Shake the vial gently until the powder is completely dissolved and no particles remain in the fluid. The reconstituted solution should be clear and colorless.

Inspect visually for particulate matter and discoloration. If the resulting solution is cloudy or contains particulate matter do not use. The reconstituted solution is 1 mg per mL glucagon.

Immediately after reconstitution, inject the solution subcutaneously or intramuscularly in the upper arm, thigh, or buttocks. In addition, healthcare providers may administer intravenously. Call for emergency assistance immediately after administering the dose.

When the patient has responded to the treatment and is able to swallow, give oral carbohydrates to restore the liver glycogen and prevent recurrence of hypoglycemia. Discard any unused portion.

2.2Dosage in Adults and Pediatric Patients for Using the Glucagon Emergency Kit for Low Blood Sugar to Treat Severe Hypoglycemia Adults and Pediatric Patients Weighing More Than 25 kg or for Pediatric Patients with Unknown Weight…

💊 Dosage Forms and Strengths 158 words ▾

3 DOSAGE FORMS AND STRENGTHS Glucagon for Injection is a white lyophilized powder supplied as follows: Treatment of Severe Hypoglycemia 1 mg single-dose vial of Glucagon for Injection with a 1 mL single-dose syringe of Sterile Water for Injection, USP (Glucagon Emergency Kit for Low Blood Sugar) Use as a Diagnostic Aid 1 mg single-dose vial of Glucagon for Injection 1 mg single-dose vial of Glucagon for Injection with a 1 mL single-dose vial of Sterile Water for Injection, USP (Diagnostic Kit) For Injection ( 3 ): Treatment of Severe Hypoglycemia: 1 mg single-dose vial of Glucagon for Injection with a 1 mL single-dose syringe of Sterile Water for Injection, USP (Glucagon Emergency Kit for Low Blood Sugar) Use as a Diagnostic Aid: 1 mg single-dose vial of Glucagon for Injection Use as a Diagnostic Aid: 1 mg single-dose vial of Glucagon for Injection with a 1 mL single-dose vial of Sterile Water for Injection, USP (Diagnostic Kit)

⛔ Contraindications 118 words ▾

4 CONTRAINDICATIONS Glucagon for Injection is contraindicated in patients with: Pheochromocytoma [see Warnings and Precautions ( 5.1 )] Insulinoma [see Warnings and Precautions ( 5.2 )] because of the risk of hypoglycemia Known hypersensitivity to glucagon or any of the excipients in Glucagon for Injection. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension [see Warnings and Precautions ( 5.3 )] Glucagonoma [see Warnings and Precautions ( 5.8 )] because of risk of hypoglycemia when used as a diagnostic aid Pheochromocytoma ( 4 ) Insulinoma ( 4 ) Known hypersensitivity to glucagon or to any of the excipients ( 4 ) Glucagonoma when used as a diagnostic aid ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Catecholamine Release in Patients with Pheochromocytoma : Contraindicated in patients with pheochromocytoma because Glucagon for Injection may stimulate the release of catecholamines from the tumor. ( 4 , 5.1 ) Hypoglycemia in Patients with Insulinoma: In patients with insulinoma, administration may produce an initial increase in blood glucose; however, Glucagon for Injection may stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. If a patient develops symptoms of hypoglycemia after a dose of Glucagon for Injection, give glucose orally or intravenously.

( 4 , 5.2 ) Hypersensitivity and Allergic Reactions: Allergic reactions have been reported and include generalized rash, and in some cases anaphylactic shock with breathing difficulties, and hypotension. ( 4 , 5.3 ) Lack of Efficacy in Patients with Decreased Hepatic Glycogen: Glucagon for Injection is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for Glucagon for Injection to be effective.

Patients with these conditions should be treated with glucose. ( 5.4 ) Necrolytic Migratory Erythema (NME): a skin rash, has been reported postmarketing following continuous glucagon infusion and resolved with discontinuation of the glucagon. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks.

( 5.5 ) Hyperglycemia in Patients with Diabetes Mellitus when Used as a Diagnostic Aid: Treatment with Glucagon for Injection in patients with diabetes mellitus may cause hyperglycemia. Monitor diabetic patients for changes in blood glucose levels during treatment and treat if indicated.( 5.6 ) Blood Pressure and Heart Rate Increase in Patients with Cardiac Disease when Used as a Diagnostic Aid: Glucagon for Injection may increase myocardial oxygen demand, blood pressure, and pulse rate. Cardiac monitoring is recommended in patients with cardiac disease during use of Glucagon for Injection as a diagnostic aid, and an increase in blood pressure and pulse rate may require therapy.

( 5.7 ) Hypoglycemia in Patients with Glucagonoma when Used as a Diagnostic Aid: Glucagon administered to patients with glucagonoma may cause secondary hypoglycemia. Test patients suspected of having glucagonoma for blood levels of glucagon prior to treatment, and monitor blood glucose levels during treatment. If a patient develops hypoglycemia, give glucose orally or intravenously.

( 5.8 )

5.1Catecholamine Release in Patients with Pheochromocytoma Glucagon for Injection is contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor [see Contraindications ( 4 )]. If the patient develops a dramatic increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure.

5.2Hypoglycemia in Patients with Insulinoma In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, Glucagon for Injection administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. Glucagon for Injection is contraindicated in patients with insulinoma [see Contraindications ( 4 )]. If a patient develops symptoms of hypoglycemia after a dose of Glucagon for Injection, give glucose orally or intravenously.

5.3Hypersensitivity and Allergic Reactions Allergic reactions have been reported with glucagon, these include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Glucagon for Injection is contraindicated in patients with a prior hypersensitivity reaction [see Contraindications ( 4…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Hypersensitivity and Allergic Reactions [see Warnings and Precautions ( 5.3 )] Necrolytic Migratory Erythema [see Warnings and Precautions ( 5.5 )] Hyperglycemia in Patients with Diabetes Mellitus when Used as a Diagnostic Aid [see Warnings and Precautions ( 5.6 )] Blood Pressure and Heart Rate Increase in Patients with Cardiac Disease when Used as a Diagnostic Aid [see Warnings and Precautions ( 5.7 )] Most common adverse reactions ( >5% or greater incidence): Injection site swelling, injection site erythema, vomiting, nausea, decreased blood pressure, asthenia, headache, dizziness, pallor, diarrhea, and somnolence.

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.

6.1Clinical Studies Experience 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 a randomized single-blind clinical study of Glucagon for Injection, 29 healthy subjects 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 Occurring in ≥ 5% of Healthy Subjects Who Received Glucagon for Injection Intramuscularly Glucagon for Injection (N=29) % of Patients Nausea 17 Vomiting 7 In a randomized, single-blind clinical study of Glucagon for Injection, 31 healthy subjects received a single dose of 1 mg Glucagon for Injection subcutaneously. Table 2 shows the most common adverse reactions that were not present at baseline and occurred in at least 5% of patients. ( 2.1 )].

Table 2: Adverse Reactions Occurring ≥5% in Healthy Subjects Who Received Glucagon for Injection Subcutaneously Glucagon for Injection (N=31) % of Patients Injection site swelling 58 Injection site erythema 55 Vomiting 36 Nausea 32 Decreased blood pressure 23 Asthenia 23 Headache 13 Dizziness 10 Pallor 10 Diarrhea 7 Somnolence 7 Other Adverse Reactions Hypertension and tachycardia have occurred with glucagon treatment.

6.2Postmarketing Experience Additional adverse reactions have been identified during post-approval use of glucagon. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. hypoglycemia and hypoglycemic coma. Patients taking indomethacin may be more likely to experience hypoglycemia following glucagon administration [see Drug Interactions ( 7 )] .

Necrolytic migratory erythema (NME) cases have been reported postmarketing in patients receiving continuous infusion of glucagon.

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Beta-blockers : Patients taking beta-blockers may have a transient increase in pulse and blood pressure. ( 7.1 ) Indomethacin: In patients taking indomethacin Glucagon for Injection may lose its ability to raise glucose or may produce hypoglycemia. (7.2) Anticholinergic drugs: Concomitant use of anticholinergic drugs with Glucagon for Injection for use as a diagnostic aid is not recommended.

(7.3) Warfarin: Glucagon for Injection may increase the anticoagulant effect of warfarin. (7.4) Insulin: Monitor blood glucose when Glucagon for Injection is used as a diagnostic aid in patients receiving insulin. (7.5)

7.1Table 3: Clinically Significant Drug Interactions with Glucagon for Injection Beta-Blockers Clinical Impact: Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given Glucagon for Injection. Intervention: The increase in blood pressure and heart rate may require therapy in patients with coronary artery disease. Indomethacin Clinical Impact: In patients taking indomethacin, Glucagon for Injection may lose its ability to raise blood glucose or may even produce 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 increases the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility. Intervention: Concomitant use of anticholinergic drugs with Glucagon for Injection for use as a diagnostic aid is not recommended.

Warfarin Clinical Impact: Glucagon for Injection may increase the anticoagulant effect of warfarin. Intervention: Monitor patients for unusual bruising or bleeding, as adjustments in warfarin dosage may be required. Insulin Clinical Impact: Insulin acts antagonistically to glucagon.

Intervention: Monitor blood glucose when Glucagon for Injection is used as a diagnostic aid in patients receiving insulin.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data from case reports and a small number of observational studies with glucagon use in pregnant women over decades of use have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Multiple small studies have demonstrated a lack of transfer of pancreatic glucagon across the human placental barrier during early gestation. In rat and rabbit reproduction studies, no embryofetal toxicity was observed with glucagon administered by injection during the period of organogenesis at doses representing up to 100 and 200 times the human dose, respectively, based on body surface area (mg/m 2 ) (see Data ).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. Data Animal Data In rats and rabbits given glucagon by injection at doses of 0.4, 2.0, and 10 mg/kg (up to 100 and 200 times the human dose based on mg/m 2 for rats and rabbits, respectively) there was no evidence of increased malformations or embryofetal lethality.

8.2Lactation Risk Summary There is no information available on the presence of glucagon in human or animal milk, the effects of glucagon on the breastfed child or the effects of glucagon on milk production. However, glucagon is a peptide and would be expected to be broken down to its constituent amino acids in the infant's digestive tract and is therefore, unlikely to cause harm to an exposed infant.

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

🤰 Pregnancy 195 words ▾

8.1Pregnancy Risk Summary Available data from case reports and a small number of observational studies with glucagon use in pregnant women over decades of use have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Multiple small studies have demonstrated a lack of transfer of pancreatic glucagon across the human placental barrier during early gestation. In rat and rabbit reproduction studies, no embryofetal toxicity was observed with glucagon administered by injection during the period of organogenesis at doses representing up to 100 and 200 times the human dose, respectively, based on body surface area (mg/m 2 ) (see Data ).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. Data Animal Data In rats and rabbits given glucagon by injection at doses of 0.4, 2.0, and 10 mg/kg (up to 100 and 200 times the human dose based on mg/m 2 for rats and rabbits, respectively) there was no evidence of increased malformations or embryofetal lethality.

🧒 Pediatric Use 52 words ▾

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

🆘 Overdosage 72 words ▾

10 OVERDOSAGE If overdosage occurs, the patient may experience nausea, vomiting, inhibition of GI tract motility, increase in blood pressure and pulse rate. In case of suspected overdosing, the serum potassium may decrease and should be monitored and corrected if needed. If the patient develops a dramatic increase in blood pressure, phentolamine mesylate has been shown to be effective in lowering blood pressure for the short time that control would be needed.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Glucagon increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver. Hepatic stores of glycogen are necessary for glucagon to produce an antihypoglycemic effect. Extrahepatic effects of glucagon include relaxation of the smooth muscle of the stomach, duodenum, small bowel, and colon.

12.2Pharmacodynamics Treatment of Severe Hypoglycemia Blood glucose concentration rises within 10 minutes of injection and maximal concentrations are attained at approximately 30 minutes after injection (see Figure 1). The duration of hyperglycemic action after intravenous or intramuscular injection is 60 to 90 minutes. Figure 1.

Recovery from Insulin Induced Hypoglycemia (mean blood glucose) After Intramuscular Injection of 1 mg of Another Glucagon for Injection Product in Type I Diabetic Men Figure Diagnostic Aid Table 4: Pharmacodynamic Properties of Another Glucagon for Injection Product For Intravenous Route a Dose is determined based on the length of the procedure. Route of Administration Dose a Time of Maximal Glucose Concentration Time of Onset of Action for GI Smooth Muscle Relaxation Duration of Smooth Muscle Relaxation Intravenous 0.25 to 0.5 mg 5 to 20 minutes 45 seconds 9 to 17 minutes Table 5 Pharmacodynamic Properties of Another Glucagon for Injection Product For Intramuscular Route a Dose is determined based on the length of the procedure.

Route of Administration Dose a Time of Maximal Glucose Concentration Time of Onset of Action for GI Smooth Muscle Relaxation Duration of Smooth Muscle Relaxation Intramuscular 1 mg 30 minutes 8 to 10 minutes 12 to 27 minutes 2 mg 30 minutes 4 to 7 minutes 21 to 32 minutes In a study in healthy subjects, a subcutaneous dose of 1 mg Glucagon for Injection resulted on average a peak blood glucose concentration of 79.3 mg/dL with a median time of 50 minutes after injection.

12.3Pharmacokinetics Absorption Following subcutaneous administration of Glucagon for Injection, the median time to reach the maximum baseline uncorrected plasma glucagon concentrations of 3533 pg/mL was approximately 10 to 13 minutes after dosing Following intramuscular administration of 1 mg dose, the maximum baseline uncorrected plasma glucagon concentrations of 3391 pg/mL were attained approximately 10 minutes after dosing. Elimination The mean apparent half-life of glucagon was about 42 minutes after subcutaneous administration.

The mean apparent half-life of glucagon was 26 minutes after intramuscular administration. Metabolism Glucagon is degraded in the liver, kidney, and plasma.

🧬 Mechanism of Action 56 words ▾

12.1Mechanism of Action Glucagon increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver. Hepatic stores of glycogen are necessary for glucagon to produce an antihypoglycemic effect. Extrahepatic effects of glucagon include relaxation of the smooth muscle of the stomach, duodenum, small bowel, and colon.

📦 How Supplied / Storage and Handling 179 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Glucagon for Injection is supplied as a sterile, lyophilized white powder available as follows: Presentation NDC Strength Description Treatment of Severe Hypoglycemia Glucagon Emergency Kit for Low Blood Sugar 63323-582-82 1 mg per vial 1 mL single-dose vial of Glucagon for Injection with 1 mL single-dose syringe of Sterile Water for Injection, USP for reconstitution Use as a Diagnostic Aid 10 Single-dose vials 63323-596-13 1 mg per vial 1 mL single-dose vial of Glucagon for Injection Diagnostic Kit 63323-593-03 1 mg per vial 1 mL single-dose vial of Glucagon for Injection with 1 mL single-dose vial of Sterile Water for Injection, USP for reconstitution

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 Use reconstituted glucagon solution immediately. Discard any unused portion [see Dosage and Administration ( 2.3 )] .

📦 Storage and Handling 67 words ▾

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 Use reconstituted glucagon solution immediately. Discard any unused portion [see Dosage and Administration ( 2.3 )] .

📋 Description 114 words ▾

11 DESCRIPTION Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. It is produced by solid phase peptide synthesis. The chemical structure of the glucagon is identical to human glucagon.

Glucagon is a single-chain polypeptide containing 29 amino acid residues. The structure of glucagon is: Molecular Formula = 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 for subcutaneous, intramuscular or intravenous use. The reconstituted solution contains glucagon as hydrochloride 1 mg per mL and lactose monohydrate (107 mg).

Glucagon for Injection is supplied at pH 2.5 to 3.5 and is soluble in water. Figure

💬 Information for Patients 103 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Recognition of Severe Hypoglycemia Inform patient and family members or caregivers on how to recognize the signs and symptoms of severe hypoglycemia and the risks of prolonged hypoglycemia. Administration Review the Patient Information and Instructions for Use with the patient and family members or caregivers.

Serious Hypersensitivity Inform patients that allergic reactions can occur with Glucagon for Injection. Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions ( 5.3 )] .

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 63323-0580-20 · Fresenius 63323-0584-65 · Fresenius →
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.