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Glycopyrrolate .2 mg/mL Injection — NDC 76045-0223-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Glycopyrrolate .2 mg/mL Injection — NDC 76045-223-30 (Billing 76045-0223-30)

by Fresenius Kabi USA, LLC · 10 SYRINGE in 1 CARTON / 3 mL in 1 SYRINGE

This is a package of Glycopyrrolate .2 mg/mL Injection from Fresenius Kabi USA, LLC, marketed since Apr 2022 and currently FDA-listed. It is this product's only package size.

NDC 76045-0223-30
🏷️ FDA NDC (as labeled) 76045-223-30 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 76045-223-30
Product NDC 76045-223
11-digit billing NDC 76045022330
NCPDP billing unit ML — per mL (volume)
RxCUI 2473383
UNII V92SO9WP2I
Application # NDA214919
SPL Set ID 685aaf64-1a64-42f9-a96f-4764d650c26f
Established class (EPC) Anticholinergic; Cholinergic Muscarinic Antagonist
Mechanism of action Cholinergic Antagonists; Cholinergic Muscarinic Antagonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-04-21
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION
Substance GLYCOPYRROLATE

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

GPI-14 4910203000E516
GCN Seq No 082030
GCN 49329
HICL code 039386
Ingredient (HICL) Glycopyrrolate/Pf
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 0.6 MG/3 ML SYR
FDB brand name Glycopyrrolate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 082030
  • GCN: 49329
  • GPI-14 (Medi-Span): 4910203000E516
  • HICL (First Databank): 039386
  • AHFS class code: 12:08.08.00
  • RxCUI (RxNorm): 2473383
Why two NDCs? The FDA registers this code as 76045-223-30 — 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 → 76045-0223-30. 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.

Clinical

Label name GLYCOPYRROLATE 0.6 MG/3 ML SYR Ingredient Glycopyrrolate/Pf
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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1598 $1.342 / J1598 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)76045-223-30
11-digit billing NDC76045-0223-30
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1598
DescriptorINJECTION, GLYCOPYRROLATE (FRESENIUS KABI), NOT THERAPEUTICALLY EQUIVALENT TO J1596, 0.1 MG
Billing units / pkg2 units
How the units are derivedThis package is 3 ML; the HCPCS unit is 0.1 MG, so one package = 2 billing units.
Medicare Part B spend (2025 (Q1-Q4))$7,578 · 1,398 claims · $5.42 per claim (all NDCs under J1598)
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
76045-0223-30 You're viewing this Main listing 10 SYRINGE in 1 CARTON / 3 mL in 1 SYRINGE 2022-04-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Glycopyrrolate .2 mg/mL 00143-9682-25 Hikma 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 70069-0011-25 Somerset 25 vials $1.514 AP Availability likely —
glycopyrrolate .2 mg/mL 71839-0123-25 BE 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 72572-0225-25 Civica, 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 63323-0578-01 Fresenius 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 65219-0801-01 Fresenius 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 71288-0414-03 Meitheal 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 72572-0226-25 Civica, 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 43547-0639-25 Solco 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 00781-3825-96 Sandoz 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 66794-0202-42 Piramal 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 70700-0165-25 Xiromed 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 65145-0102-25 Caplin 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 25021-0796-01 Sagent 10 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 70069-0617-25 Somerset 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 43547-0543-25 Solco 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 62332-0607-25 Alembic 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 00517-4601-25 American 25 vials $1.514 AP Availability likely —
Glyrx-Pf .2 mg/mL 51754-6013-03 Exela 10 syringes — — FDA listed —
Glycopyrrolate .2 mg/mL 76045-0023-30 Fresenius 10 syringes — — FDA listed —
Glycopyrrolate .2 mg/mLthis 76045-0223-30 Fresenius 10 syringes — — 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 00143-9587-25 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 55150-0292-01 AuroMedics 25 vials — — 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 75834-0193-25 Nivagen 25 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 1Ml .2 mg/mL 70700-0264-22 XIROMED 1 vial — — 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 71872-7093-01 Medical 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 71872-7094-01 Medical 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 71872-7174-01 Medical 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 71872-7175-01 Medical 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 71872-7181-01 Medical 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 71872-7196-01 Medical 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 71872-7208-01 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 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 70756-0631-25 Lifestar 25 vials — — 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 51754-6000-04 Exela 25 vials — — 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 00404-9867-01 Henry 1 vial — AP Discontinued —
Glycopyrrolate .2 mg/mL 84549-0543-25 ProPharma 1 ml — AP FDA listed —
Glycopyrrolate .2 mg/mL 68083-0379-10 Gland 10 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 70121-1394-05 Amneal 25 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 55154-7475-05 Cardinal 5 vials — AP 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 00404-9775-01 Henry 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 84549-0204-42 ProPharma 5 ml — AP FDA listed —
Glycopyrrolate .2 mg/mL 16729-0471-08 Accord 25 vials — 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 68083-0376-25 Gland 25 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 51662-1487-01 HF 1 ml — 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 84549-0205-41 ProPharma 20 ml — AP FDA listed —
Glycopyrrolate .2 mg/mL 51662-1425-01 HF 1 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 the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
On the market since
Apr 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

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

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

Inactive Ingredients / Excipients

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

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

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 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.

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationNDA214919 (NDA)
Labeler code76045
First marketedApr 2022
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.

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 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 193 words ▾

1 INDICATIONS AND USAGE Glycopyrrolate Injection, USP (0.2 mg/mL) is an anticholinergic indicated for use in: anesthesia (all ages) for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation, intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias, and for protection against peripheral muscarinic effects of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing agents. peptic ulcer (adults) as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.

Glycopyrrolate Injection is an anticholinergic indicated: in anesthesia (adult and pediatric patients) for reduction of airway or gastric secretions, and volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation, intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias, and for protection against peripheral muscarinic effects of cholinergic agents. ( 1 ) in peptic ulcer (adults) as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or oral medication is not tolerated.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Glycopyrrolate Injection may be administered intramuscularly, or intravenously, without dilution, in the following indications: Adults ( 2.2 ) Preanesthetic Medication: 0.004 mg/kg IM, given 30 to 60 minutes prior to the anticipated time of induction of anesthesia Intraoperative Medication: single doses of 0.1 mg IV and repeated, as needed, at intervals of 2 to 3 minutes Reversal of Neuromuscular Blockade: 0.2 mg for each 1 mg of neostigmine or 5 mg of pyridostigmine Peptic Ulcer: 0.1 mg IV or IM at 4-hour intervals, 3 or 4 times daily Pediatric patients ( 2.3 ) Preanesthetic Medication: 0.004 mg/kg IM, given 30 to 60 minutes prior to the anticipated time of induction of anesthesia.

Patients under 2 years of age may require up to 0.009 mg/kg Intraoperative Medication: 0.004 mg/kg IV, not to exceed 0.1 mg in a single dose and repeated, as needed, at intervals of 2 to 3 minutes Reversal of Neuromuscular Blockade: 0.2 mg for each 1 mg of neostigmine or 5 mg of pyridostigmine Peptic Ulcer: Glycopyrrolate Injection is not indicated for the treatment of peptic ulcer in pediatric patients Do not use prefilled syringe to administer a dose of less than 0.1 mg (0.5 mL). ( 2.3 ) See Full Prescribing Information for preparation, handling, and instructions for use of pre-filled syringe ( 2.4 , 2.5 )

2.1General Dosing and Administration Information 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. Do not introduce any other fluid into the syringe at any time.

Do not dilute for IV push. Do not re-sterilize the syringe. Do not use this product on a sterile field.

This product is for single dose only.

2.2Dosing in 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.

Attempt to determine the etiology of the arrhythmia, and perform the surgical or anesthetic manipulations necessary to correct parasympathetic imbalance. Reversal of Neuromuscular Blockade The recommended dose of Glycopyrrolate Injection is 0.2 mg for each 1 mg of neostigmine or 5 mg of pyridostigmine. 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. Frequency of administration should be dictated by patient response up to a maximum of four times daily.

2.3Dosing in Pediatric Patients 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. Patients under 2 years of age may require up to 0.009 mg/kg. Do not use this prefilled syringe to administer a dose of less than 0.1 mg (0.5 mL).

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 minute… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 38 words ▾

3 DOSAGE FORMS AND STRENGTHS Glycopyrrolate Injection, USP, is a clear, colorless solution available in 0.6 mg/3 mL (0.2 mg/mL) single-dose, prefilled, disposable syringes. Injection : 0.6 mg/3 mL (0.2 mg/mL) prefilled, single-dose, disposable syringes. ( 3 )

⛔ Contraindications 133 words ▾

4 CONTRAINDICATIONS Glycopyrrolate Injection is contraindicated in: patients with known hypersensitivity to Glycopyrrolate Injection or any of its inactive ingredients. peptic ulcer 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.

Known hypersensitivity to glycopyrrolate or any of its inactive ingredients. ( 4 ) Peptic ulcer patients with glaucoma; obstructive uropathy; obstructive disease of the gastrointestinal tract; 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. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Precipitation of Acute Glaucoma : Glycopyrrolate Injection may cause mydriasis and increase intraocular pressure in patients with glaucoma. Advise patients with glaucoma to promptly seek medical care if they experience symptoms of acute angle closure glaucoma. ( 5.1 ) Drowsiness or Blurred Vision : May cause drowsiness or blurred vision.

Advise patients not to drive or perform hazardous work until resolved. ( 5.2 ) Heat Prostration : Advise patients to avoid exertion and high environmental temperatures after receiving Glycopyrrolate Injection. ( 5.3 ) Intestinal Obstruction : Diarrhea may be an early symptom of incomplete intestinal obstruction.

Avoid use in patients with diarrhea and ileostomy or colostomy. ( 5.4 ) Tachycardia : Increase in heart rate may occur. Use with caution in patients with coronary artery disease, congestive heart failure, cardiac arrhythmias, hypertension, or hyperthyroidism.

( 5.5 )

5.1Precipitation of Acute Glaucoma Glycopyrrolate Injection may cause mydriasis and increase intraocular pressure in patients with glaucoma. Advise patients with glaucoma to promptly seek medical care in the event that they experience symptoms of acute angle closure glaucoma (pain and reddening of the eyes, accompanied by dilated pupils).

5.2Drowsiness or Blurred Vision Glycopyrrolate Injection may cause drowsiness or blurred vision. Warn patients not to participate in activities requiring mental alertness, such as operating a motor vehicle or other machinery, or performing hazardous work, until these issues resolve.

5.3Heat Prostration In the presence of fever, high environmental temperature, and/or during physical exercise, heat prostration can occur with use of anticholinergic agents including Glycopyrrolate Injection (due to decreased sweating), particularly in children and the elderly. Advise patients to avoid exertion and high environmental temperature after receiving Glycopyrrolate Injection.

5.4Intestinal Obstruction Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with Glycopyrrolate Injection is inappropriate and possibly harmful. Avoid use in patients with these conditions.

5.5Tachycardia Investigate any tachycardia before giving Glycopyrrolate Injection because an increase in the heart rate may occur. Use with caution in patients with coronary artery disease, congestive heart failure, cardiac arrhythmias, hypertension, and/or hyperthyroidism.

5.6Risk of Use in Patients with Renal Impairment Renal elimination of glycopyrrolate may be severely impaired in patients with renal failure. Dosage adjustments may be necessary in this population [ see Pharmacokinetics ( 12.3 ) ]

5.7Autonomic Neuropathy, Hepatic Disease, Ulcerative Colitis, Prostatic Hypertrophy, or Hiatal Hernia Use Glycopyrrolate Injection with caution in the elderly and in all patients with autonomic neuropathy, hepatic disease, ulcerative colitis, prostatic hypertrophy, or hiatal hernia, because anticholinergic drugs may aggravate these conditions. Consider dose reduction and closely monitor the elderly and patients with autonomic neuropathy, hepatic disease, ulcerative colitis, prostatic hypertrophy, or hiatal hernia.

5.8Delayed Gastric Emptying/Gastric Stasis The use of anticholinergetic drugs, including Glycopyrrolate Injection, in the treatment of gastric ulcer may produce a delay in gastric emptying due to antral statis. Monitor patients for symptoms such as vomiting, dyspepsia, early satiety, abdominal distention, and increased abdominal pain. Discontinue Glycopyrrolate Injection treatment if these symptoms develop or worsen on treatment.

5.9Light Sensitivity Patients may experience sensitivity of the eyes to light. Advise patients to protect their eyes from light after receiving Glycopyrrolate Injection.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following adverse reactions were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions to anticholinergics 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.

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.

Most common adverse reactions are related to anticholinergic pharmacology and 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; bradycardia; palpitation; and decreased sweating. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 110 words ▾

7 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 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.

Other anticholinergics or drugs with anticholinergic activity: May intensify the antimuscarinic effects and result in an increase in anticholinergic side effects. ( 7 ) Potassium Chloride in a Wax Matrix: May increase severity of potassium chloride-induced gastrointestinal lesions. ( 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pediatric Use : 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. Large doses may cause hyperexcitability. ( 8.4 )

8.1Pregnancy Risk summary Limited data are available with glycopyrrolate use during pregnancy have not identified a drug-associated risk of birth defects and miscarriage, however, most of the reported exposures occurred after the first trimester. Most of the available data are based on studies with exposures that occurred at the time of Cesarean-section delivery, and these studies have not identified an adverse effect on maternal outcomes or infant Apgar scores ( see Data ). In animal reproduction studies in pregnant rats and rabbits administered glycopyrrolate orally (rats) and intramuscularly (rabbits) during the period of organogenesis, no teratogenic effects were seen at 320-times and 5 times the maximum recommended human dose (MRHD) of 2 mg (on a mg/m 2 basis), respectively ( see Data ).

The estimated background risk for major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2-4% and 15−20%, respectively.

Data Human Data Published, randomized, controlled trials over several decades, which compared the use of glycopyrrolate to another antimuscarinic agent in pregnant women during Cesarean section, have not identified adverse maternal or infant outcomes. In normal doses (0.004 mg/kg), glycopyrrolate does not appear to affect fetal heart rate or fetal heart rate variability to a significant degree. Concentrations of glycopyrrolate in umbilical venous and arterial 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. There are no studies on the safety of glycopyrrolate exposure during the period of organogenesis, and therefore, it is not possible to draw any conclusions on the risk of birth defects following exposure to glycopyrrolate during pregnancy. In addition, there are no data on the risk of miscarriage following fetal exposure to glycopyrrolate.

Animal Data 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. A preclinical study on reproductive performance of rats given glycopyrrolate resulted in a decreased rate of conception and survival at weaning.

8.2Lactation Risk summary There are no data on the presence of glycopyrrolate in either human milk or animal milk, the effects on the breastfed infant, or the effects on milk production. As with other anticholinergics, glycopyrrolate may cause suppression of lactation [see Adverse Reactions ( 6 )] . The developmental and health benefits of breast feeding should be considered along with the mother's clinical need for Glycopyrrolate Injection and any potential adverse effects on the breastfed child from Glycopyrrolate Injection or from the underlying maternal condition.

8.4Pediatric Use 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… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk summary Limited data are available with glycopyrrolate use during pregnancy have not identified a drug-associated risk of birth defects and miscarriage, however, most of the reported exposures occurred after the first trimester. Most of the available data are based on studies with exposures that occurred at the time of Cesarean-section delivery, and these studies have not identified an adverse effect on maternal outcomes or infant Apgar scores ( see Data ). In animal reproduction studies in pregnant rats and rabbits administered glycopyrrolate orally (rats) and intramuscularly (rabbits) during the period of organogenesis, no teratogenic effects were seen at 320-times and 5 times the maximum recommended human dose (MRHD) of 2 mg (on a mg/m 2 basis), respectively ( see Data ).

The estimated background risk for major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2-4% and 15−20%, respectively.

Data Human Data Published, randomized, controlled trials over several decades, which compared the use of glycopyrrolate to another antimuscarinic agent in pregnant women during Cesarean section, have not identified adverse maternal or infant outcomes. In normal doses (0.004 mg/kg), glycopyrrolate does not appear to affect fetal heart rate or fetal heart rate variability to a significant degree. Concentrations of glycopyrrolate in umbilical venous and arterial 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. There are no studies on the safety of glycopyrrolate exposure during the period of organogenesis, and therefore, it is not possible to draw any conclusions on the risk of birth defects following exposure to glycopyrrolate during pregnancy. In addition, there are no data on the risk of miscarriage following fetal exposure to glycopyrrolate.

Animal Data 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. A preclinical study on reproductive performance of rats given glycopyrrolate resulted in a decreased rate of conception and survival at weaning.

🧒 Pediatric Use 99 words ▾

8.4Pediatric Use 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.

🧓 Geriatric Use 83 words ▾

8.5Geriatric 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 198 words ▾

10 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 ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action 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.

12.2Pharmacodynamics 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. 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.

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.

12.3Pharmacokinetics 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. Elimination 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 ± 0.27 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 the 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. * 0 to 8 hr 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* Specific Populations Pediatric Patients Following IV administration (5 mcg/kg glycopyrrolate) to infants and children, the mean t 1/2 values were reported to be between 21.6 and 130.0 minutes and between 19.2 and 99.2 minutes, respectively.

Patients with 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.

🧬 Mechanism of Action 86 words ▾

12.1Mechanism of Action 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.

📦 How Supplied / Storage and Handling 98 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Glycopyrrolate Injection, USP, 0.2 mg per mL without preservative is available as: Product Code Unit of Sale Strength Each 720330 NDC 76045-023-30 Unit of 10 0.6 mg/3 mL (0.2 mg/mL) NDC 76045-023-00 3 mL single-dose pre-filled disposable syringe RF720330 NDC 76045-223-30 Unit of 10 0.6 mg/3 mL (0.2 mg/mL) NDC 76045-223-03 3 mL single-dose pre-filled disposable syringe This product contains an RFID. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Sensitive to heat – Do not autoclave.

Discard unused portion. Do not place syringe on a sterile field.

📋 Description 130 words ▾

11 DESCRIPTION Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. It is intended for intramuscular or intravenous administration. Each 1 mL contains: Glycopyrrolate, USP 0.2 mg, Water for Injection, USP q.s., pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.

Solution does not contain preservatives. 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: Glycopyrrolate occurs as a white, odorless crystalline powder.

It is soluble in water and alcohol, and practically insoluble in chloroform and ether. It 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). Structural Formula

💬 Information for Patients 218 words ▾

17 PATIENT COUNSELING INFORMATION Drowsiness or Blurred Vision : Inform patients that Glycopyrrolate Injection may cause drowsiness or blurred vision. Warn patients not to operate a motor vehicle or other machinery or perform hazardous work until these issues resolve. [ see Warnings and Precautions ( 5.2 ) ]. Heat Prostration : Inform patients that in the presence of fever, high environmental temperature and/or during physical exercise, heat prostration can occur with use of anticholinergic agents, including Glycopyrrolate Injection (due to decreased sweating), particularly in children and the elderly.

Advise patients to avoid exertion and high environmental temperature after receiving Glycopyrrolate Injection [see Warnings and Precautions ( 5.3 )] . Light Sensitivity : Advise patients that Glycopyrrolate Injection may cause sensitivity of the eyes to light and to protect their eyes from light after receiving Glycopyrrolate Injection [see Warnings and Precautions ( 5.9 )] . Drug Interactions : Inform patients that Glycopyrrolate Injection may interact with other drugs.

Advise patients to report to their healthcare provider the use of any other medication [see Drug Interactions ( 7 ) ]. For more information concerning this drug, please call Fresenius Kabi USA, LLC at 1-800-551-7176. 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.

U.S. Patent 9,731,082 www.fresenius-kabi.com/us 451718D Fresenius Kabi Logo

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics 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. Elimination 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 ± 0.27 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 the 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. * 0 to 8 hr 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* Specific Populations Pediatric Patients Following IV administration (5 mcg/kg glycopyrrolate) to infants and children, the mean t 1/2 values were reported to be between 21.6 and 130.0 minutes and between 19.2 and 99.2 minutes, respectively.

Patients with 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.

🧬 Pharmacodynamics 151 words ▾

12.2Pharmacodynamics 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. 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.

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.

🧪 Nonclinical Toxicology 73 words ▾

13 NONCLINICAL TOXICOLOGY Carcinogenesis Long-term studies in animals have not been performed to evaluate carcinogenic potential. Mutagenesis Studies to evaluate the mutagenic potential of glycopyrrolate have not been conducted. Impairment of Fertility In reproduction studies in rats, dietary administration of glycopyrrolate resulted in diminished rates of conception in a dose-related manner.

Other studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate.

📖 Instructions for Use 138 words ▾

2.5Instructions for Use of Pre-filled Syringe: Figure 1: Outer Packaging and Prefilled Syringe Inspect the outer packaging (blister pack) to confirm the integrity of the packaging. Do not use if the blister pack or the prefilled syringe has been damaged. Remove the syringe from the outer packaging.

(See Figure 2 ) Figure 2 Visually inspect the syringe. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Twist off the syringe tip cap.

Do not remove the label around the luer lock collar. (See Figure 3 ) Figure 3 Expel air bubble(s). Adjust the dose (if applicable).

Administer the dose ensuring that pressure is maintained on the plunger rod during the entire administration. Discard the used syringe into an appropriate receptacle. Figure 1 Figure 2 Figure 3

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

PACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Syringe Label 3 mL Single-Dose Prefilled Syringe. For IM or IV Use . Rx only Glycopyrrolate Injection, USP 0.6 mg / 3 mL (0.2 mg /mL) PACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Syringe Label

PACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Blister Label RF720330 NDC 76045-223-03 Glycopyrrolate Injection, USP 0.6 mg / 3 mL (0.2 mg /mL) For Intramuscular or Intravenous Use. Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Blister Label

PACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Carton Label Rx only NDC 76045-223-30 Glycopyrrolate Injection, USP 0.6 mg / 3 mL (0.2 mg /mL) For Intramuscular or Intravenous Use. Do NOT place syringe on a Sterile Field. 10 x 3 ml Single-Dose Prefilled Syringes Discard unused portion. PACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Carton Label

PACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Syringe Label 3 ml Single-Dose Prefilled Syringe. For IM or IV Use . Rx only Glycopyrrolate Injection, USP 0.6 mg / 3 mL (0.2 mg /mL) PACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Syringe Labe

PACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Blister Label Rx only NDC 76045-023-00 Glycopyrrolate Injection, USP 0.6 mg / 3 mL (0.2 mg /mL) For Intramuscular or Intravenous Use. PACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Blister Label

PACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Carton Label Rx only NDC 76045-023-30 Glycopyrrolate Injection, USP 0.6 mg / 3 mL (0.2 mg /mL) For Intramuscular or Intravenous Use. Do NOT place syringe on a Sterile Field. 10 x 3 ml Single-Dose Prefilled Syringes Discard unused portion. PACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Carton Label

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

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.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The 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 Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Fresenius Kabi USA, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1598 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.
← 76045-0221-50 · Fresenius 76045-0235-10 · Fresenius →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.