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Glycopyrrolate .2 mg/mL Injection, Solution, 25 vials — NDC 65219-0801-01 package photo

Glycopyrrolate .2 mg/mL Injection, Solution, 25 vials

by Fresenius Kabi USA, LLC · 25 VIAL, SINGLE-DOSE in 1 CARTON (65219-801-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-801-00)
NDC 65219-0801-01
🏷️ FDA NDC (as labeled) 65219-801-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⚠ On shortage
🗂️ 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

⚠️
Active FDA shortage. Glycopyrrolate Injection is currently reported in shortage by the FDA. Shortage details →
⚠️
Other active recalls for Glycopyrrolate (different manufacturers) — 4 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 16, 2026 — Presence of Particulate Matter: Hair was found in product (Fresenius Kabi USA, LLC) · FDA recall D-0725-2026
Class II · Jul 14, 2026 — Failed Impurities/Degradation Specifications (Precision Dose Inc.) · FDA recall D-0741-2026
Class III · Dec 15, 2025 — Failed Impurities/Degradation Specifications (NOVADOZ PHARMACEUTICALS LLC) · FDA recall D-0300-2026
Class II · Dec 16, 2022 — Failed Impurities/Degradation Specifications (Aurolife Pharma, LLC) · FDA recall D-0087-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 65219-801-01
Product NDC 65219-801
11-digit billing NDC 65219080101
NCPDP billing unit ML — per mL (volume)
RxCUI 1731582
UNII V92SO9WP2I
UPC 0365219801009
Application # ANDA209328
SPL Set ID 250eeef7-b1a9-45e7-a927-7807232e10be
Established class (EPC) Anticholinergic
Mechanism of action Cholinergic Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-12-31
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance GLYCOPYRROLATE
GPI-14 49102030002010
GCN Seq No 004886
GCN 19121
HICL code 002028
Ingredient (HICL) Glycopyrrolate
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J2
Therapeutic class — intermediate (HIC2) Anticholinergics
HIC3 code J2B
Therapeutic class — specific (HIC3) Anticholinergics,Quaternary Ammonium
AHFS code 12:08.08.00
AHFS class Antimuscarinics/Antispasmodics
FDB label name GLYCOPYRROLATE 0.2 MG/ML VIAL
FDB brand name Glycopyrrolate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 65219-801-01 — 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 → 65219-0801-01. 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 Anticholinergic class.

Pharmacologic class Anticholinergic, Cholinergic Muscarinic Antagonist
Drug family (ATC) Antihidrotics
How it works Cholinergic Muscarinic Antagonists, Cholinergic Antagonists
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 applicationANDA209328 (ANDA)
Labeler code65219
First marketedDec 2023
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 GLYCOPYRROLATE 0.2 MG/ML VIAL Ingredient Glycopyrrolate
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

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

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

  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $1.481 $37.02 / 25 ml
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1596 $0.365 / J1596 unit —
NADAC price history (per mL) — tap or hover for the price & month
Aug 2025 Apr 2026 Jun 2026 Aug 2026 $1.514 $1.286
▼ Down 2% over the last 7 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)65219-801-01
11-digit billing NDC65219-0801-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1596
DescriptorINJECTION, GLYCOPYRROLATE, 0.1 MG
Billing units / pkg2 units
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Glycopyrrolate .2 mg/mL 00143-9682-25 Hikma 25 vials $1.481 AP Availability likely —
Glycopyrrolate .2 mg/mL 00517-4601-25 American 25 vials $1.481 AP Availability likely —
Glycopyrrolate .2 mg/mL 00781-3825-96 Sandoz 25 vials $1.481 AP Availability likely —
Glycopyrrolate .2 mg/mL 25021-0796-01 Sagent 10 vials $1.481 AP Availability likely —
Glycopyrrolate .2 mg/mL 43547-0543-25 Solco 25 vials $1.481 AP Availability likely —
Glycopyrrolate .2 mg/mL 43547-0639-25 Solco 25 vials $1.481 AP Availability likely —
Glycopyrrolate .2 mg/mL 62332-0607-25 Alembic 25 vials $1.481 AP Availability likely —
Glycopyrrolate .2 mg/mL 63323-0578-01 Fresenius 25 vials $1.481 AP Availability likely —
Glycopyrrolate .2 mg/mL 65145-0102-25 Caplin 25 vials $1.481 AP Availability likely —
Glycopyrrolate .2 mg/mLthis 65219-0801-01 Fresenius 25 vials $1.481 AP Availability likely —
Glycopyrrolate .2 mg/mL 66794-0202-42 Piramal 25 vials $1.481 AP Availability likely —
Glycopyrrolate .2 mg/mL 70069-0011-25 Somerset 25 vials $1.481 AP Availability likely —
Glycopyrrolate .2 mg/mL 70069-0617-25 Somerset 25 vials $1.481 AP Availability likely —
Glycopyrrolate .2 mg/mL 70700-0165-25 Xiromed 25 vials $1.481 AP Availability likely —
Glycopyrrolate .2 mg/mL 71288-0414-03 Meitheal 25 vials $1.481 AP Availability likely —
glycopyrrolate .2 mg/mL 71839-0123-25 BE 25 vials $1.481 AP Availability likely —
Glycopyrrolate .2 mg/mL 72572-0225-25 Civica, 25 vials $1.481 AP Availability likely —
Glycopyrrolate .2 mg/mL 72572-0226-25 Civica, 25 vials $1.481 AP Availability likely —
Glycopyrrolate .2 mg/mL 00143-9587-25 Hikma 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 00404-9775-01 Henry 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 00404-9867-01 Henry 1 vial — AP Discontinued —
Glycopyrrolate .2 mg/mL 16729-0471-08 Accord 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 51662-1425-01 HF 1 ml — AP FDA listed —
Glycopyrrolate .2 mg/mL 51662-1487-01 HF 1 ml — AP FDA listed —
Glyrx-Pf .2 mg/mL 51754-6000-04 Exela 25 vials — — FDA listed —
Glycopyrrolate .2 mg/mL 55150-0292-01 AuroMedics 25 vials — — FDA listed —
Glycopyrrolate .2 mg/mL 55154-7475-05 Cardinal 5 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 68083-0376-25 Gland 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 70121-1394-05 Amneal 25 vials — AP FDA listed —
Glycopyrrolate 1Ml .2 mg/mL 70700-0264-22 XIROMED 1 vial — — FDA listed —
Glycopyrrolate .2 mg/mL 70756-0631-25 Lifestar 25 vials — — FDA listed —
Glycopyrrolate .2 mg/mL 71872-7093-01 Medical 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 71872-7174-01 Medical 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 71872-7181-01 Medical 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 71872-7208-01 Medical 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 71872-7224-01 Medical 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 71872-7238-01 Medical 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 75834-0193-25 Nivagen 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 84549-0543-25 ProPharma 1 ml — AP FDA listed —
Glycopyrrolate .2 mg/mL 00143-9584-10 Hikma 10 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 00143-9585-25 Hikma 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 00143-9586-25 Hikma 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 00143-9679-10 Hikma 10 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 00143-9680-25 Hikma 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 00143-9681-25 Hikma 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 55150-0293-02 AuroMedics 25 vials — — FDA listed —
Glycopyrrolate .2 mg/mL 55150-0294-05 AuroMedics 25 vials — — FDA listed —
Glycopyrrolate .2 mg/mL 55150-0295-20 AuroMedics 25 vials — — FDA listed —
Glycopyrrolate .2 mg/mL 70069-0012-25 Somerset 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 70069-0013-25 Somerset 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 70069-0014-10 Somerset 10 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 75834-0194-25 Nivagen 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 75834-0195-25 Nivagen 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 75834-0196-10 Nivagen 10 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 71288-0415-06 Meitheal 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 71872-7012-01 Medical 10 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 71872-7013-01 Medical 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 71872-7094-01 Medical 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 71872-7175-01 Medical 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 71872-7196-01 Medical 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 71872-7292-01 Medical 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 71872-7307-01 Medical 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 76045-0203-10 Fresenius 1 syringe — AP FDA listed —
Glycopyrrolate .2 mg/mL 76045-0206-10 Fresenius 1 syringe — AP FDA listed —
Glycopyrrolate .2 mg/mL 76045-0208-20 Fresenius 1 syringe — AP FDA listed —
Glycopyrrolate .2 mg/mL 16729-0474-03 Accord 10 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 70756-0634-10 Lifestar 10 vials — — FDA listed —
Glycopyrrolate .2 mg/mL 00641-6213-10 Hikma 10 syringes — AP FDA listed —
Glycopyrrolate .2 mg/mL 16729-0472-08 Accord 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 68083-0378-25 Gland 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 00517-4602-25 American 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 84549-0203-42 ProPharma 2 ml — AP FDA listed —
Glycopyrrolate .2 mg/mL 62332-0628-25 Alembic 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 66794-0204-42 Piramal 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 70069-0616-10 Somerset 10 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 86211-0113-10 Jvet 10 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 70700-0167-25 Xiromed 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 70756-0632-25 Lifestar 25 vials — — FDA listed —
Glycopyrrolate .2 mg/mL 00404-9776-05 Henry 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 16729-0473-03 Accord 10 vials — AP FDA listed —
Glyrx-Pf .2 mg/mL 51754-6013-03 Exela 10 syringes — — FDA listed —
Glycopyrrolate .2 mg/mL 62332-0629-10 Alembic 10 vials — AP FDA listed —
glycopyrrolate .2 mg/mL 70121-1699-02 Amneal 12 syringes — AP FDA listed —
Glycopyrrolate .2 mg/mL 70700-0903-23 Xiromed, 10 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 68083-0379-10 Gland 10 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 00517-4605-25 American 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 00641-6212-10 Hikma 10 syringes — AP FDA listed —
Glycopyrrolate .2 mg/mL 51662-1554-03 HF 25 pouches — AP FDA listed —
Glyrx-Pf .2 mg/mL 51754-6001-04 Exela 25 vials — — FDA listed —
Glycopyrrolate .2 mg/mL 70069-0618-25 Somerset 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 70756-0633-25 Lifestar 25 vials — — FDA listed —
Glycopyrrolate .2 mg/mL 76045-0223-30 Fresenius 10 syringes — — FDA listed —
Glycopyrrolate .2 mg/mL 84549-0204-42 ProPharma 5 ml — AP FDA listed —
Glycopyrrolate .2 mg/mL 66794-0203-42 Piramal 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 66794-0205-41 Piramal 10 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 70069-0619-25 Somerset 25 vials — AP FDA listed —
glycopyrrolate .2 mg/mL 70121-1698-02 Amneal 12 syringes — AP FDA listed —
Glycopyrrolate .2 mg/mL 70700-0166-25 Xiromed 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 00517-4620-25 American 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 51662-1601-01 HF 5 ml — AP FDA listed —
Glyrx-Pf .2 mg/mL 51754-6015-03 Exela 10 syringes — — FDA listed —
Glycopyrrolate .2 mg/mL 62332-0627-25 Alembic 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 70700-0902-25 Xiromed, 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 76045-0023-30 Fresenius 10 syringes — — FDA listed —
Glycopyrrolate .2 mg/mL 84549-0205-41 ProPharma 20 ml — AP FDA listed —
Glycopyrrolate .2 mg/mL 51662-1484-01 HF 20 ml — AP FDA listed —
Glycopyrrolate .2 mg/mL 68083-0377-25 Gland 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 70700-0168-23 Xiromed 10 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 00404-9777-20 Henry 1 vial — 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

🏛️
2023
On the market since
Dec 2023
📍
2026
Currently FDA-listed
3 years 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.

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

Medicare Part D (outpatient prescription) spending for Glycopyrrolate — the program that covers self-administered drugs. 18 manufacturers.
⚠️ 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 Glycopyrrolate. 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
$2.44M
Claims incl. refills
67.4K
Beneficiaries
34.1K
Spend / beneficiary
$71.59
Spend / claim
$36.23
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 Glycopyrrolate — the ingredient across all brands.

Top reported reactions

Dyspnoea3,566
Cough1,693
Device Delivery System Issue1,666
Death1,631
Asthma1,478
Wrong Technique In Device Usage Process1,317
Chronic Obstructive Pulmonary Disease1,210

Age at onset

Neonate23
Infant13
Child55
Adolescent26
Adult1,670
Elderly2,451

Reporter sex

19,422 reports
Male · 43%
Female · 57%
Unknown · 0%

Serious outcomes

Hospitalization4,741
Death2,286
Life-threatening641
Disabling296
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,124 0
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
65219-0801-01 You're viewing this 25 VIAL, SINGLE-DOSE in 1 CARTON (65219-801-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-801-00) 2023-12-31 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 122 words ▾

INDICATIONS AND USAGE: Anesthesia Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.

Peptic Ulcer For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION: NOTE: CONTAINS BENZYL ALCOHOL (see PRECAUTIONS ). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Glycopyrrolate Injection may be administered intramuscularly, or intravenously, without dilution, in the following indications.

Adults Preanesthetic Medication The recommended dose of Glycopyrrolate Injection is 0.004 mg/kg by intramuscular injection, given 30 to 60 minutes prior to the anticipated time of induction of anesthesia or at the time the preanesthetic narcotic and/or sedative are administered. Intraoperative Medication Glycopyrrolate Injection may be used during surgery to counteract drug-induced or vagal reflexes and their associated arrhythmias (e.g., bradycardia). It should be administered intravenously as single doses of 0.1 mg and repeated, as needed, at intervals of 2 to 3 minutes.

The usual attempts should be made to determine the etiology of the arrhythmia, and the surgical or anesthetic manipulations necessary to correct parasympathetic imbalance should be performed. Reversal of Neuromuscular Blockade The recommended dose of Glycopyrrolate Injection is 0.2 mg for each 1.0 mg of neostigmine or 5.0 mg of pyridostigmine. In order to minimize the appearance of cardiac side effects, the drugs may be administered simultaneously by intravenous injection and may be mixed in the same syringe.

Peptic Ulcer The usual recommended dose of Glycopyrrolate Injection is 0.1 mg administered at 4-hour intervals, 3 or 4 times daily intravenously or intramuscularly. Where more profound effect is required, 0.2 mg may be given. Some patients may need only a single dose, and frequency of administration should be dictated by patient response up to a maximum of four times daily.

Glycopyrrolate Injection is not recommended for the treatment of peptic ulcer in pediatric patients (see PRECAUTIONS , Pediatric Use ). Pediatric Patients (see PRECAUTIONS , Pediatric Use ) Preanesthetic Medication The recommended dose of Glycopyrrolate Injection in pediatric patients is 0.004 mg/kg intramuscularly, given 30 to 60 minutes prior to the anticipated time of induction of anesthesia or at the time the preanesthetic narcotic and/or sedative are administered. Infants (1 month to 2 years of age) may require up to 0.009 mg/kg.

Intraoperative Medication Because of the long duration of action of Glycopyrrolate Injection if used as preanesthetic medication, additional Glycopyrrolate Injection for anticholinergic effect intraoperatively is rarely needed; in the event it is required the recommended pediatric dose is 0.004 mg/kg intravenously, not to exceed 0.1 mg in a single dose which may be repeated, as needed, at intervals of 2 to 3 minutes. The usual attempts should be made to determine the etiology of the arrhythmia, and the surgical or anesthetic manipulations necessary to correct parasympathetic imbalance should be performed.

Reversal of Neuromuscular Blockade The recommended pediatric dose of Glycopyrrolate Injection is 0.2 mg for each 1.0 mg of neostigmine or 5.0 mg of pyridostigmine. In order to minimize the appearance of cardiac side effects, the drugs may be administered simultaneously by intravenous injection and may be mixed in the same syringe. Peptic Ulcer Glycopyrrolate Injection is not recommended for the treatment of peptic ulcer in pediatric patients (see PRECAUTIONS , Pediatric Use ).

⛔ Contraindications 89 words ▾

CONTRAINDICATIONS: Known hypersensitivity to glycopyrrolate or any of its inactive ingredients. In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, Glycopyrrolate Injection may be contraindicated in patients with the following concurrent conditions: glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.

⚠️ Warnings ~1 min read ▾

WARNINGS: This drug should be used with great caution, if at all, in patients with glaucoma. Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol.

The amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol. Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. The amount of benzyl alcohol at which toxicity may occur is not known.

If the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources. (see PRECAUTIONS , Pediatric Use ). Glycopyrrolate Injection may produce drowsiness or blurred vision.

The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug. In addition, in the presence of fever, high environmental temperature and/or during physical exercise, heat prostration can occur with use of anticholinergic agents including glycopyrrolate (due to decreased sweating), particularly in children and the elderly. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy.

In this instance treatment with Glycopyrrolate Injection would be inappropriate and possibly harmful.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS: 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. Anticholinergics, including Glycopyrrolate Injection, can produce certain effects, most of which are extensions of their pharmacologic actions. Adverse reactions may include xerostomia (dry mouth); urinary hesitancy and retention; blurred vision and photophobia due to mydriasis (dilation of the pupil); cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.

In addition, the following adverse events have been reported from post-marketing experience with glycopyrrolate: malignant hyperthermia; cardiac arrhythmias (including bradycardia, ventricular tachycardia, ventricular fibrillation); cardiac arrest; hypertension; hypotension; seizures; and respiratory arrest. Post-marketing reports have included cases of heart block and QTc interval prolongation associated with the combined use of glycopyrrolate and an anticholinesterase. Injection site reactions including pruritus, edema, erythema, and pain have also been reported.

Glycopyrrolate is chemically a quaternary ammonium compound; hence, its passage across lipid membranes, such as the blood–brain barrier is limited in contrast to atropine sulfate and scopolamine hydrobromide. For this reason the occurrence of CNS-related side effects is lower, in comparison to their incidence following administration of anticholinergics which are chemically tertiary amines that can cross this barrier readily.

🔄 Drug Interactions 69 words ▾

Drug Interactions The concurrent use of Glycopyrrolate Injection with other anticholinergics or medications with anticholinergic activity, such as phenothiazines, antiparkinson drugs, or tricyclic antidepressants, may intensify the antimuscarinic effects and may result in an increase in anticholinergic side effects. Concomitant administration of Glycopyrrolate Injection and potassium chloride in a wax matrix may increase the severity of potassium chloride-induced gastrointestinal lesions as a result of a slower gastrointestinal transit time.

🤰 Pregnancy 207 words ▾

Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies with glycopyrrolate were performed in rats at a dietary dose of approximately 65 mg/kg/day (exposure was approximately 320 times the maximum recommended daily human dose of 2 mg on a mg/m 2 basis) and rabbits at intramuscular doses of up to 0.5 mg/kg/day (exposure was approximately 5 times the maximum recommended daily human dose on a mg/m 2 basis). These studies produced no teratogenic effects to the fetus. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Single-dose studies in humans found that very small amounts of glycopyrrolate passed the placental barrier. Nonteratogenic Effects Published literature suggest the following regarding the use of glycopyrrolate during pregnancy. Unlike atropine, glycopyrrolate in normal doses (0.004 mg/kg) does not appear to affect fetal heart rate or fetal heart rate variability to a significant degree.

Concentrations of glycopyrrolate in umbilical venous and aterial blood and in the amniotic fluid are low after intramuscular administration to parturients. Therefore, glycopyrrolate does not appear to penetrate through the placental barrier in significant amounts. In reproduction studies in rats, dietary administration of glycopyrrolate resulted in diminished rats of pup survival in a dose-related manner.

🧒 Pediatric Use ~1 min read ▾

Pediatric Use Due to its benzyl alcohol content, Glycopyrrolate Injection should not be used in neonates, i.e., patients less than 1 month of age. Safety and effectiveness in pediatric patients below the age of 16 years have not been established. Safety and effectiveness in pediatric patients have not been established for the management of peptic ulcer.

Dysrhythmias associated with the use of glycopyrrolate intravenously as a premedicant or during anesthesia have been observed in pediatric patients. Infants, patients with Down’s syndrome, and pediatric patients with spastic paralysis or brain damage may experience an increased response to anticholinergics, thus increasing the potential for side effects. A paradoxical reaction characterized by hyperexcitability may occur in pediatric patients taking large doses of anticholinergics including Glycopyrrolate Injection.

Infants and young children are especially susceptible to the toxic effects of anticholinergics. Benzyl alcohol, a component of this drug product, has been associated with serious adverse events and death, particularly in pediatric patients. The “gasping syndrome,” (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages > 99 mg/kg/day in neonates and low-birth-weight neonates.

Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hemotologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Although normal therapeutic doses of this product deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome,” the minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birthweight infants, as well as patients receiving high dosages, may be more likely to develop toxicity.

Practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources.

🧓 Geriatric Use 82 words ▾

Geriatric Use Clinical Studies of Glycopyrrolate Injection 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 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 therapy.

🆘 Overdosage 197 words ▾

OVERDOSAGE: To combat peripheral anticholinergic effects, a quaternary ammonium anticholinesterase such as neostigmine methylsulfate (which does not cross the blood–brain barrier) may be given intravenously in increments of 0.25 mg in adults. This dosage may be repeated every five to ten minutes until anticholinergic overactivity is reversed or up to a maximum of 2.5 mg. Proportionately smaller doses should be used in pediatric patients.

Indication for repetitive doses of neostigmine should be based on close monitoring of the decrease in heart rate and the return of bowel sounds. If CNS symptoms (e.g., excitement, restlessness, convulsions, psychotic behavior) occur, physostigmine (which does cross the blood–brain barrier) may be used. Physostigmine 0.5 to 2 mg should be slowly administered intravenously and repeated as necessary up to a total of 5 mg in adults.

Proportionately smaller doses should be used in pediatric patients. To combat hypotension, administer IV fluids and/or pressor agents along with supportive care. Fever should be treated symptomatically.

Following overdosage, a curare-like action may occur, i.e., neuromuscular blockade leading to muscular weakness and possible paralysis. In the event of a curare-like effect on respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY: Glycopyrrolate, like other anticholinergic (antimuscarinic) agents, inhibits the action of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of smooth muscle, cardiac muscle, the sinoatrial node, the atrioventricular node, exocrine glands and, to a limited degree, in the autonomic ganglia. Thus, it diminishes the volume and free acidity of gastric secretions and controls excessive pharyngeal, tracheal, and bronchial secretions.

Glycopyrrolate antagonizes muscarinic symptoms (e.g., bronchorrhea, bronchospasm, bradycardia, and intestinal hypermotility) induced by cholinergic drugs such as the anticholinesterases. The highly polar quaternary ammonium group of glycopyrrolate limits its passage across lipid membranes, such as the blood-brain barrier, in contrast to atropine sulfate and scopolamine hydrobromide, which are highly non-polar tertiary amines which penetrate lipid barriers easily. With intravenous injection, the onset of action is generally evident within one minute.

Following intramuscular administration, the onset of action is noted in 15 to 30 minutes, with peak effects occurring within approximately 30 to 45 minutes. The vagal blocking effects persist for 2 to 3 hours and the antisialagogue effects persist up to 7 hours, periods longer than for atropine. Pharmacokinetics The following pharmacokinetic information and conclusions were obtained from published studies that used nonspecific assay methods.

Distribution The mean volume of distribution of glycopyrrolate was estimated to be 0.42 ±

0.22L/kg. Metabolism The in vivo metabolism of glycopyrrolate in humans has not been studied. Excretion The mean clearance and mean t 1/2 values were reported to be 0.54 ±

0.14L/kg/hr and 0.83 ± 0.13 hr, respectively post IV administration. After IV administration of a 0.2 mg radiolabeled glycopyrrolate, 85% of dose recovered was recovered in urine 48 hours postdose and some of radioactivity was also recovered in bile. After IM administration of glycopyrrolate to adults, the mean t 1/2 value is reported to be between 0.55 to 1.25 hrs.

Over 80% of IM dose administered was recovered in urine and the bile as unchanged drug and half the IM dose is excreted within 3 hrs. The following table summarizes the mean and standard deviation of pharmacokinetic parameters from a study. Group t 1/2 (hr) V ss (L/kg) CL (L/kg/hr) T max (min) C max (mcg/L) AUC (mcg/L•hr) (6 mcg/kg IV) 0.83 ± 0.27 0.42 ± 0.22 0.54 ± 0.14 - - 8.64 ± 1.49** (8 mcg/kg IM) - - - 27.48 ± 6.12 3.47 ± 1.48 6.64 ± 2.33** *0 to12 hr **0 to 8 hr Special Populations Renal/Hepatic Impairment Gender Gender differences in pharmacokinetics of glycopyrrolate have not been investigated.

Renal Impairment In one study glycopyrrolate was administered IV in uremic patients undergoing renal transplantation. The mean elimination half-life was significantly longer (46.8 minutes) than in healthy patients (18.6 minutes). The mean area-under-the-concentration-time curve (10.6 hr-mcg/L), mean plasma clearance (0.43 L/hr/kg), and mean 3-hour urine excretion (0.7%) for glycopyrrolate were also significantly different than those of controls (3.73 hr-mcg/L,

1.14L/hr/kg, and 50%, respectively). These results suggest that the elimination of glycopyrrolate is severely impaired in patients with renal failure. Hepatic Impairment Pharmacokinetic information in patients with hepatic impairment is unavailable. Pediatrics Following IV administration (5 mcg/kg glycopyrrolate) to infants and children, the mean t ½ values were reported to be between 21.6 and 130.0 minutes and between 19.2 and 99.2 minutes, respectively.

📦 How Supplied / Storage and Handling 140 words ▾

HOW SUPPLIED: Glycopyrrolate Injection, USP is available as follows: Product Code Unit of Sale Strength Each RF578101 NDC 65219-801-01 Unit of 25 0.2 mg per mL NDC 65219-801-00 1 mL Vial Single Dose Vial This product contains an RFID. 578101 NDC 63323-578-01 Unit of 25 0.2 mg per mL NDC 63323-578-03 1 mL Vial Single Dose Vial 578102 NDC 63323-578-02 Unit of 25 0.4 mg per 2 mL (0.2 mg per mL) NDC 63323-578-04 2 mL Vial Single Dose Vial 578105 NDC 63323-578-05 Unit of 25 1 mg per 5 mL (0.2 mg per mL) NDC 63323-578-07 5 mL Vial Multiple Dose Vial Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

The brand names mentioned in this document are the trademarks of their respective owners. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451526B Revised: February 2023 logo

📋 Description 129 words ▾

DESCRIPTION: Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains: Glycopyrrolate, 0.2 mg; water for injection, q.s.; benzyl alcohol, 0.9% (preservative); pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. Glycopyrrolate is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide.

Its structural formula is as follows: C 19 H 28 BrNO 3 M.W. 398.33 Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether.

Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol /water system is 0.304 (log 10 P= -1.52) at ambient room temperature (24°C). structure

💬 Information for Patients 84 words ▾

Information for Patients Because Glycopyrrolate Injection may produce drowsiness or blurred vision, the patient should be cautioned not to engage in activities requiring mental alertness and/or visual acuity such as operating a motor vehicle or other machinery, or performing hazardous work while taking this drug (see WARNINGS ). The patient also should be cautioned about the use of this drug during exercise or hot weather since overheating may result in heat stroke. The patient may experience a possible sensitivity of the eyes to light.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.