Home › NDC Lookup › Ingredients › Glucagon › 00378-8067-90
📦image loading
(from DailyMed)

Glucagon Kit — NDC 0378-8067-90 (Billing 00378-8067-90)

by Mylan Pharmaceuticals Inc. · 1 KIT in 1 KIT * 1 mL in 1 VIAL * 1 mL in 1 SYRINGE

This is a package of Glucagon Kit from Mylan Pharmaceuticals Inc., marketed since Feb 2025 and currently FDA-listed; retail pharmacies pay about $154.20 per unit (NADAC). It is this product's only package size.

NDC 00378-8067-90
🏷️ FDA NDC (as labeled) 0378-8067-90 billing pads the labeler segment with a zero
Rx only Generic 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

⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0378-8067-90
Product NDC 0378-8067
11-digit billing NDC 00378806790
NCPDP billing unit EA — each (per item)
RxCUI 310497
Application # ANDA204468
SPL Set ID 15b49500-0aae-4e25-9a1d-709983233cc6
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-02-26
Dosage form KIT
TE code (Orange Book) AP · RLD · RS

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

GPI-14 27300010002105
GCN Seq No 041660
GCN 25473
HICL code 002795
Ingredient (HICL) Glucagon
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
Quick answers
  • GSN (GCN sequence number): 041660
  • GCN: 25473
  • GPI-14 (Medi-Span): 27300010002105
  • HICL (First Databank): 002795
  • AHFS class code: 68:22.12.00
  • RxCUI (RxNorm): 310497
Why two NDCs? The FDA registers this code as 0378-8067-90 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00378-8067-90. 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.

Clinical

Label name GLUCAGON 1 MG EMERGENCY KIT Ingredient Glucagon
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.

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 $154.203 —
Medicaid paysCMS SDUD · 12 mo $196.01 —
Medicare drug plans payPart D · Q2 2026 $213.35 —
Medicare Part B allowsASP · J1610 $117.331 / J1610 unit —
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $219.573 $154.203
▼ Down 30% 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)0378-8067-90
11-digit billing NDC00378-8067-90
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ1610
DescriptorINJECTION, GLUCAGON HYDROCHLORIDE, PER 1 MG
Billing units / pkg1 units
How the units are derivedThis package is 1 EA; the HCPCS unit is 1 MG, so one package = 1 billing unit.
Medicare Part B spend (2026 (Q1))$585,205 · 3,369 claims · $173.70 per claim (all NDCs under J1610)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00378-8067-90 You're viewing this Main listing 1 KIT in 1 KIT * 1 mL in 1 VIAL * 1 mL in 1 SYRINGE 2025-02-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Glucagonthis 00378-8067-90 Mylan 1 kit $154.203 AP Availability likely —
Glucagon 00548-5850-00 Amphastar 1 kit $154.203 AP Availability likely —
Glucagon 69097-0027-50 Cipla 1 kit $154.203 AP Availability likely —
Glucagon 70748-0311-01 Lupin 1 kit $154.203 AP Availability likely —
Glucagon 63323-0582-82 Fresenius 1 kit $240.404 — Availability likely +56%
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 a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Feb 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

Inactive Ingredients / Excipients

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

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerMylan Pharmaceuticals Inc.
Application holderMYLAN LABORATORIES LTD
FDA applicationANDA204468 (ANDA)
Labeler code00378
First marketedFeb 2025
Product typeHuman Prescription Drug
Portfolio473 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 108 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 mellitus.

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 adult and pediatric patients to treat severe hypoglycemia ( 2.2 ) • Adults and Pediatric Patients Weighing 20 kg or More: ▪ 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) may be administered while waiting for emergency assistance. • Pediatric Patients Weighing Less Than 20 kg: ▪ The recommended dosage is 0.5 mg (0.5 mL) or dose equivalent to 20 mcg/kg to 30 mcg/kg 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) may be administered while waiting for emergency assistance.

Important Administration Instructions for Using Glucagon for Injection 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 as a Diagnostic Aid ( 2.4 ) • Doses required for relaxation of the stomach, duodenum, and small bowel, depend on the onset and duration of effect required for the examination. • The dose for relaxation of the duodenum and small bowel is 0.25 mg to 0.5 mg given intravenously or 1 mg given intramuscularly. • For the stomach 0.5 mg intravenous or 2 mg intramuscular doses are recommended. • For the colon, it is recommended that a 2 mg dose be administered intramuscularly approximately 10 minutes prior to the procedure. • See the Full Prescribing Information for administration instructions ( 2.3 )

2.1Important Administration Instructions for Using Glucagon for Injection 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. • Swirl the vial gently until the powder is completely dissolved and no particles remain in the fluid. The reconstituted solution should be clear and of a water-like consistency at time of use. 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. Use immediately after reconstitution. • Immediately after reconstitution, use the same syringe to withdraw the correct dose of Glucagon for Injection. • 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. • If there has been no response after 15 minutes, an additional dose of Glucagon for Injection may be administered while waiting for emergency assistance. • 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 for Treatment of Severe Hypoglycemia Adults and Pediatric… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 68 words ▾

3 DOSAGE FORMS AND STRENGTHS Glucagon for Injection, USP is a white to off white lyophilized powder or plug supplied as follows: • Single-dose vial containing 1 mg Glucagon for Injection, USP with a pre-filled syringe containing 1 mL of diluent for Glucagon. For Injection: single-dose vial containing 1 mg Glucagon for Injection, USP with a prefilled syringe containing 1 mL of diluent for Glucagon ( 3 )

⛔ Contraindications 133 words ▾

4 CONTRAINDICATIONS Glucagon for Injection is contraindicated in patients with: • Pheochromocytoma because of the risk of substantial increase in blood pressure [see Warning and Precautions (5.1) ] • Insulinoma because of the risk of hypoglycemia [see Warning and Precautions (5.2) ] • 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 Warning and Precautions (5.3) ] • Glucagonoma when used as a diagnostic aid because of the risk of hypoglycemia [see Warnings and Precautions (5.8) ] • 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 • Substantial Increase in Blood Pressure 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, glucagon 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, which have been reported with glucagon, may occur 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 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 administration to be effective. Patients with these conditions should be treated with glucose. ( 5.4 ) • Necrolytic Migratory Erythema (NME): Necrolytic migratory erythema (NME), a skin rash, have been reported post marketing 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: Glucagon administered to patients with glucagonoma may cause secondary hypoglycemia.

Test patients suspected of having glucagonoma for blood levels of glucagon prior to treatment. ( 4 , 5.8 )

5.1Substantial Increase in Blood Pressure 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 substantial 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) ] . 5.4… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~1 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) ] The following 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. • Injection site reactions including erythema and swelling • Nausea • Vomiting • Headache • Dizziness • Asthenia • Pallor • Diarrhea • Somnolence • Generalized allergic reactions including anaphylactic shock with breathing difficulties and hypotension • Hypertension and tachycardia • Decreased blood pressure. Hypotension has been reported up to 2 hours after administration in patients receiving glucagon as premedication for upper gastrointestinal endoscopy procedures. • 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 post marketing in patients receiving continuous infusion of glucagon. Glucagon adverse reactions include: injection site reactions, nausea, vomiting, headache, dizziness, asthenia, pallor, diarrhea, somnolence, and decreased blood pressure. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Table 1: 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 increase 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. • Beta-blockers : Patients taking beta-blockers may have a transient increase in pulse and blood pressure. ( 7 ) • Indomethacin : In patients taking indomethacin Glucagon for Injection may lose its ability to raise glucose or may produce hypoglycemia. ( 7 ) • Anticholinergic drugs : Concomitant use of anticholinergic drugs with Glucagon for Injection for use as a diagnostic aid is not recommended.

( 7 ) • Warfarin : Glucagon for Injection may increase the anticoagulant effect of warfarin. ( 7 ) • Insulin : Monitor blood glucose when Glucagon for Injection is used as a diagnostic aid in patients receiving insulin. ( 7 )

👥 Use in Specific Populations ~2 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 a rat reproduction study, no embryofetal toxicity was observed with glucagon administered by injection during the period of organogenesis at doses representing up to 40 times the human dose, 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% to 4% and 15% to 20%, respectively. Data Animal Data In pregnant rats given animal sourced glucagon twice-daily by injection at doses up to 2 mg/kg (up to 40 times the human dose based on body surface area extrapolation, mg/m 2 ) during the period of organogenesis, 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.

8.5Geriatric Use Clinical studies of glucagon did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient when used as a diagnostic aid should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🤰 Pregnancy 198 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 a rat reproduction study, no embryofetal toxicity was observed with glucagon administered by injection during the period of organogenesis at doses representing up to 40 times the human dose, 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% to 4% and 15% to 20%, respectively. Data Animal Data In pregnant rats given animal sourced glucagon twice-daily by injection at doses up to 2 mg/kg (up to 40 times the human dose based on body surface area extrapolation, mg/m 2 ) during the period of organogenesis, 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.

🧓 Geriatric Use 89 words ▾

8.5Geriatric Use Clinical studies of glucagon did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient when used as a diagnostic aid should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 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 concentrations rise within 10 minutes of subcutaneous injection and mean maximal concentration of 136 mg/dL is attained 30 minutes after injection (see Figure 1). Similarly, following intramuscular injection, the mean peak glucose level was 138 mg/dL, which occurred at 26 minutes after injection. Figure 1 Mean (SE) blood glucose concentrations after subcutaneous injection of glucagon (1 mg) in 25 normal volunteers Figure 1 Mean (SE) blood glucose concentrations after subcutaneous injection of glucagon (1 mg) in 25 normal volunteers Diagnostic Aid Table 2 displays the dose and pharmacodynamics properties of Glucagon for Injection as a diagnostic aid during radiological examination.

Table 2: Dose and Pharmacodynamic properties of Glucagon for Injection as a Diagnostic Aid Dose Route of administration Time of onset of action Approximate duration of effect 0.25 to 0.5 mg Intravenous 1 minute 9 to 17 minutes 1 mg Intramuscular 8 to 10 minutes 12 to 27 minutes 2 mg *Administration of 2 mg doses produces a higher incidence of nausea and vomiting than do lower doses. Intravenous 1 minute 22 to 25 minutes 2 mg Intramuscular 4 to 7 minutes 21 to 32 minutes

12.3Pharmacokinetics Absorption Glucagon injected through the intramuscular route achieved mean peak plasma levels of 6.9 ng/mL at approximately 13 minutes after dosing; and 7.9 ng/mL at approximately 20 minutes after subcutaneous dosing. Administration of the intravenous glucagon showed dose proportionality of the pharmacokinetics between 0.25 and 2 mg. Figure 2 Mean (SE) serum glucagon concentrations after subcutaneous injection of glucagon (1 mg) in 25 normal volunteers Figure 2 Mean (SE) serum glucagon concentrations after subcutaneous injection of glucagon (1 mg) in 25 normal volunteers Distribution The mean volume of distribution was

0.25L/kg. Elimination The mean clearance was 13.5 mL/min/kg. The mean half-life ranged from 8 to 18 minutes. 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 140 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Glucagon Emergency Kit for Low Blood Sugar contains 1 mg Glucagon for Injection, USP (a sterile, lyophilized white to off-white powder or plug) in a single-dose vial and 1 prefilled syringe containing 1 mL of diluent of Glucagon. • 1 mg per vial - with 1 mL of diluting solution (PFS) (1s) NDC of Pre-filled Syringe: 0378-8066-32; NDC of Vial Label: 0378-8065-32; NDC of Carton: 0378-8067-90.

16.2Storage and Handling Before Reconstitution: Store Glucagon for Injection, USP at controlled room temperature 20° to 25°C (68° to 77°F) [See USP]. Do not use Glucagon for Injection, USP if the expiration date has passed. Do not freeze. Keep in its original package and away from light. After Reconstitution: Use reconstituted Glucagon for Injection, USP immediately. Discard unused portion [see Dosage and Administration (2.3) ].

📋 Description 200 words ▾

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

Glucagon is a single-chain polypeptide that contains 29 amino acid residues and has a molecular weight of 3482.8 Daltons. The empirical formula is C 153 H 225 N 43 O 49 S. The primary sequence of glucagon is shown below.

Glucagon (synthetic origin) is a white to off-white powder. It is relatively insoluble in water but is soluble at a pH of less than 3 or more than 9.5. Glucagon for injection, USP is a sterile, white to off white lyophilized powder or plug in a vial and a syringe of sterile diluent for intravenous, intramuscular, or subcutaneous use.

The vial contains 1 mg of glucagon USP, 49 mg of lactose monohydrate. Hydrochloric acid may have been added during manufacture to adjust the pH of the glucagon to 2.5 to 3.0. One International Unit of glucagon is equivalent to 1 mg of glucagon.

The 1 mL diluent syringe contains 12 mg of glycerin, 1 mg hydrochloric acid, and Water for Injection, at pH 1.8 to 2.2. Glucagon Primary Sequence

💬 Information for Patients 117 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) ]. Manufactured for: Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A Manufactured by: Mylan Laboratories Limited Bangalore, India DECEMBER 2024

🧬 Pharmacokinetics 120 words ▾

12.3Pharmacokinetics Absorption Glucagon injected through the intramuscular route achieved mean peak plasma levels of 6.9 ng/mL at approximately 13 minutes after dosing; and 7.9 ng/mL at approximately 20 minutes after subcutaneous dosing. Administration of the intravenous glucagon showed dose proportionality of the pharmacokinetics between 0.25 and 2 mg. Figure 2 Mean (SE) serum glucagon concentrations after subcutaneous injection of glucagon (1 mg) in 25 normal volunteers Figure 2 Mean (SE) serum glucagon concentrations after subcutaneous injection of glucagon (1 mg) in 25 normal volunteers Distribution The mean volume of distribution was

0.25L/kg. Elimination The mean clearance was 13.5 mL/min/kg. The mean half-life ranged from 8 to 18 minutes. Metabolism Glucagon is degraded in the liver, kidney and plasma.

🧬 Pharmacodynamics 194 words ▾

12.2Pharmacodynamics Treatment of Severe Hypoglycemia Blood glucose concentrations rise within 10 minutes of subcutaneous injection and mean maximal concentration of 136 mg/dL is attained 30 minutes after injection (see Figure 1). Similarly, following intramuscular injection, the mean peak glucose level was 138 mg/dL, which occurred at 26 minutes after injection. Figure 1 Mean (SE) blood glucose concentrations after subcutaneous injection of glucagon (1 mg) in 25 normal volunteers Figure 1 Mean (SE) blood glucose concentrations after subcutaneous injection of glucagon (1 mg) in 25 normal volunteers Diagnostic Aid Table 2 displays the dose and pharmacodynamics properties of Glucagon for Injection as a diagnostic aid during radiological examination.

Table 2: Dose and Pharmacodynamic properties of Glucagon for Injection as a Diagnostic Aid Dose Route of administration Time of onset of action Approximate duration of effect 0.25 to 0.5 mg Intravenous 1 minute 9 to 17 minutes 1 mg Intramuscular 8 to 10 minutes 12 to 27 minutes 2 mg *Administration of 2 mg doses produces a higher incidence of nausea and vomiting than do lower doses. Intravenous 1 minute 22 to 25 minutes 2 mg Intramuscular 4 to 7 minutes 21 to 32 minutes

🧪 Nonclinical Toxicology 63 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long term studies in animals to evaluate carcinogenic potential have not been performed. Recombinant glucagon was positive in the bacterial Ames assay. It was determined that an increase in colony counts was related to technical difficulties in running this assay with peptides. Studies in rats have shown that glucagon does not cause impaired fertility.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 60 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long term studies in animals to evaluate carcinogenic potential have not been performed. Recombinant glucagon was positive in the bacterial Ames assay. It was determined that an increase in colony counts was related to technical difficulties in running this assay with peptides. Studies in rats have shown that glucagon does not cause impaired fertility.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Glucagon (GLOO-ka-gon) for Injection, USP for subcutaneous, intramuscular, or intravenous use What is Glucagon for Injection? Glucagon for Injection is a prescription medicine used: • to treat very low blood sugar (severe hypoglycemia) in people with diabetes mellitus. • to stop movement in the intestines in people receiving radiology exams. Who should not use Glucagon for Injection?

Do not use Glucagon for Injection if: • you have a tumor in the gland on top of your kidneys (adrenal gland) called a pheochromocytoma. • you have a tumor in your pancreas called an insulinoma. • you have a tumor in your pancreas called a glucagonoma because it could cause low blood sugar when used for your radiology exam • you are allergic to glucagon or lactose or any of the ingredients in Glucagon for Injection. See the end of this Patient Information leaflet for a complete list of ingredients in Glucagon for Injection .

Before using Glucagon for Injection, tell your healthcare provider about all of your medical conditions, including if you: • have adrenal problems. • have pancreas problems. • have not had anything to eat or have not had a drink of water for a long time (prolonged fasting or starvation). • have low blood sugar that does not go away (chronic hypoglycemia). • have heart problems. • are pregnant or plan to become pregnant. It is not known if Glucagon will harm your unborn baby. • are breastfeeding or plan to breastfeed.

It is not known if Glucagon passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Glucagon may affect the way other medicines work, and other medicines may affect how Glucagon works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I use Glucagon for Injection? • Read the detailed Instructions for Use that come with Glucagon for Injection. • Use Glucagon for Injection exactly how and when your healthcare provider tells you to use it. • Make sure you and your caregiver knows where you keep your Glucagon for Injection and how to use Glucagon for Injection the right way before you need their help. • Act quickly.

Having very low blood sugar for a period of time may be harmful. • After Glucagon is mixed, make sure it is clear and of water-like consistency. Do not use if it has particles or is discolored. • After giving Glucagon for Injection the caregiver should call for emergency medical help right away. • Turn the person on their side to prevent them from choking. • If the person does not respond after 15 minutes, another dose may be given, if available while waiting for emergency medical help. • Eat sugar or a sugar sweetened product such as a regular soft drink or fruit juice as soon as you are able to swallow.

Tell your healthcare provider each time you use Glucagon for Injection. Your healthcare provider may need to change the dose of your diabetes medicines. What are the possible side effects of Glucagon for Injection?

Glucagon may cause serious side effects, including: • High blood pressure . Glucagon can cause high blood pressure in certain people with tumors in their adrenal glands called pheochromocytoma. • Low blood sugar . Glucagon can cause low blood sugar in people with tumors in their pancreas called insulinomas and glucagonomas.

Signs and symptoms of low blood sugar may include: • sweating • drowsiness • dizziness • sleep disturbances • irregular heartbeat • anxiety • tremor • blurred vision • hunger • slurred speech • restlessness • depressed mood • tingling in the hands, • feet, lips or tongue • irritability • abnormal behavior • lightheadedness • unsteady movement • inability to concentrate • personality changes • headache Very low blood sugar can cause confusion, seizures, passing out (loss of consciousness) and death. Talk to your healthcare provider about how to tel… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE Glucagon (GLOO-ka-gon) for Injection, USP Important • Read and become familiar with this Instructions for Use before an emergency happens. • Show your family members and others where you keep your Glucagon Emergency Kit for Low Blood Sugar and how to use it the right way. • Call for emergency medical help right after you use Glucagon for Injection. • Do not share your Glucagon syringes or needles with another person. You may give other people a serious infection or get a serious infection from them. • The prefilled syringe that comes with your Glucagon Emergency Kit for Low Blood Sugar is for use with Glucagon for Injection only.

Do not use Glucagon for Injection syringes to inject other medicines. How should I store Glucagon for Injection? Before you mix the Glucagon powder and liquid: • Store Glucagon at room temperature between 68° to 77°F (20° to 25°C). • Check the expiration date on the vial of Glucagon for Injection.

Do not use Glucagon for Injection if the expiration date has passed. • Do not freeze Glucagon. • Keep Glucagon in its original package and away from light. After you mix the Glucagon powder and liquid: • Use Glucagon for Injection right away. • Throw away unused Glucagon for Injection. Supplies you will need for your Glucagon for Injection • Glucagon Emergency Kit for Low Blood Sugar contains (see Figure A): • 1 single-dose vial containing 1 mg Glucagon for Injection (as a sterile, white to off-white lyophilized powder or plug) • 1 prefilled syringe containing 1 mL of diluent for Glucagon Figure A • 1 puncture resistant container for throwing away used needles and syringes.

See “How should I dispose of (throw away) used Glucagon syringes?” at the end of these instructions. • Alcohol swab (not included in kit) Preparing to Inject Glucagon for Injection • The Glucagon medicine comes as a dry powder. Before you use Glucagon for Injection, you must mix the dry powder with the syringe of diluent that comes in the Glucagon Emergency Kit for Low Blood Sugar. Do not use any other liquid to mix the medicine.

Step 1: Remove the flip-off seal from the vial of Glucagon. Wipe the rubber stopper on the vial with an alcohol swab (see Figure B). Figure B Step 2: Remove the needle protector from the syringe.

Inject all of the diluent in the prefilled syringe into the vial containing Glucagon powder (see Figure C). Do not remove the plastic clip from the syringe. Remove syringe from the vial.

Figure C Step 3: Swirl the vial gently until the Glucagon powder dissolves completely (see Figure D). Glucagon should not be used unless the solution is clear and of a water-like consistency. Figure D Step 4: Using the same syringe, hold the vial upside down and, making sure the needle tip remains in the solution, gently withdraw all the solution (1 mg mark on syringe) from the vial (see Figure E).

The backstop and plastic clip on the syringe will prevent the rubber stopper from being pulled out of the syringe; however, if the plunger rod separates from the rubber stopper, simply reinsert the rod by turning it clockwise. The usual adult dose is 1 mg. For children weighing less than 44 lb (20 kg), give 1/2 adult dose (0.5 mg).

For these children, withdraw 1/2 of the solution from the vial (0.5 mg mark on syringe). Figure E Injecting Glucagon for Injection Step 5: Choose your injection site and clean with an alcohol wipe. Injection sites for Glucagon for Injection are the buttocks, upper arm, or thigh.

Step 6: Insert the needle into the loose tissue under the clean injection site and push the plunger to inject all (or 1/2 for children weighing less than 44 lbs.) of the Glucagon for Injection. After injecting Glucagon for Injection Step 7: Apply light pressure at the injection site and withdraw the needle. Press an alcohol swab against the injection site.

Throw away your used syringe with the needle attached and any Glucagon that you did not use in an FDA-cleared sharps disposal container right away after use. See “How… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL – 1 mg NDC 0378-8067-90 Glucagon Emergency Kit for Low Blood Sugar Glucagon for Injection USP, 1 mg per vial Diluent for Glucagon, 1 mL syringe Rx only 1034120 Must reconstitute vial contents with diluent. IMPORTANT - Read the enclosed insert carefully for directions before using. PHARMACISTS-Please detach 'INFORMATION FOR THE USER' and give to the patient.

This kit contains: 1 single-dose vial of Glucagon for Injection, USP: 1 mg glucagon, USP and 49 mg lactose monohydrate; hydrochloric acid may have been added to adjust the pH of glucagon. 1 syringe of diluent for Glucagon: 12 mg/ml glycerin, water for injection, and 1 mg hydrochloric acid. Usual Dose - 1 mg subcutaneously, intramuscularly, or intravenously for adults and pediatric patients weighing more than 20 kg.

For smaller pediatric patients, see enclosed insert. DO NOT REMOVE PLASTIC CLIP FROM THE ACCOMPANYING SYRINGE. Mix immediately before use.

Add the entire contents of the accompanying syringe into the Glucagon vial. Mix well and gently withdraw the entire contents of the vial back into the syringe. Before Reconstitution: Store at controlled room g temperature 20° to 25° C (68° to 77° F) [See USP]. 􀈚 NON-RETURNABLE.

Discard unused portion. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Made in India Code No.: KR/DRUGS/KTK/28/384/2009 1033014 Glucagon Emergency Kit for Low Blood Sugar Container Label Front Glucagon Emergency Kit for Low Blood Sugar Container Label Back

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
11.6K
Units reimbursed last 4 qtrs
14.9K
Gross reimbursed last 4 qtrs
$2.91M
Avg / prescription
$251.60
Avg / unit
$196.01
Latest quarter Q1 2026
2.6KRx
Medicaid pays / ea
$196.01
gross reimbursed
vs
NADAC / ea
$154.20
acquisition cost
=
Spread
+$41.8060
+27% 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 ⓘ
33% FFS 67% MCO
Fee-for-service · 3,874 Rx Managed care · 7,703 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 1,244 units · 15.9 per 100k residents WA Idaho: 32 units · 1.6 per 100k residents ID Montana: 15 units · 1.3 per 100k residents MT North Dakota: no data reported ND Minnesota: 325 units · 5.7 per 100k residents MN Wisconsin: 235 units · 4.0 per 100k residents WI Michigan: 74 units · 0.7 per 100k residents MI New York: 524 units · 2.7 per 100k residents NY Vermont: no data reported VT New Hampshire: 41 units · 2.9 per 100k residents NH Oregon: 205 units · 4.8 per 100k residents OR Nevada: 668 units · 20.9 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 120 units · 1.0 per 100k residents IL Indiana: 98 units · 1.4 per 100k residents IN Ohio: 145 units · 1.2 per 100k residents OH Pennsylvania: 778 units · 6.0 per 100k residents PA New Jersey: 423 units · 4.6 per 100k residents NJ Massachusetts: 398 units · 5.7 per 100k residents MA California: 2,711 units · 7.0 per 100k residents CA Utah: 15 units · 0.4 per 100k residents UT Colorado: 95 units · 1.6 per 100k residents CO Nebraska: no data reported NE Missouri: 356 units · 5.7 per 100k residents MO Kentucky: 325 units · 7.2 per 100k residents KY West Virginia: 160 units · 9.0 per 100k residents WV Virginia: 193 units · 2.2 per 100k residents VA Maryland: 542 units · 8.8 per 100k residents MD Connecticut: 190 units · 5.3 per 100k residents CT Rhode Island: 24 units · 2.2 per 100k residents RI Arizona: 284 units · 3.8 per 100k residents AZ New Mexico: 13 units · 0.6 per 100k residents NM Kansas: 29 units · 1.0 per 100k residents KS Arkansas: no data reported AR Tennessee: 108 units · 1.5 per 100k residents TN North Carolina: 446 units · 4.1 per 100k residents NC South Carolina: 494 units · 9.2 per 100k residents SC Delaware: no data reported DE Oklahoma: 44 units · 1.1 per 100k residents OK Louisiana: 125 units · 2.7 per 100k residents LA Mississippi: 51 units · 1.7 per 100k residents MS Alabama: 47 units · 0.9 per 100k residents AL Georgia: 936 units · 8.5 per 100k residents GA D.C.: 35 units · 5.2 per 100k residents DC Hawaii: 157 units · 10.9 per 100k residents HI Texas: 869 units · 2.8 per 100k residents TX Florida: 1,258 units · 5.6 per 100k residents FL
Units reimbursed · per 100k residents
0.420.9
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 Nevada 20.9 /100k
2 Washington 15.9 /100k
3 Hawaii 10.9 /100k
4 South Carolina 9.2 /100k
5 West Virginia 9.0 /100k
6 Maryland 8.8 /100k
7 Georgia 8.5 /100k
8 Kentucky 7.2 /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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Glucagon — the ingredient across all brands.

Top reported reactions

Dyspnoea367
Acute Kidney Injury320
Hypotension293
Hypoglycaemia271
Condition Aggravated253
Toxicity To Various Agents238
Nausea232

Age at onset

Neonate13
Infant10
Child11
Adolescent28
Adult356
Elderly267

Reporter sex

4,129 reports
Male · 48%
Female · 52%
Unknown · 0%

Serious outcomes

Hospitalization1,990
Death669
Life-threatening652
Disabling136
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 450 148
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ 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 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 Mylan Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Mylan 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1610 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.
← 00378-8056-49 · Mylan 00378-8082-20 · Mylan →
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.