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GLYRX-PF glycopyrrolate .2 mg/mL Injection, Solution

by Exela Pharma Sciences, LLC · 10 SYRINGE, PLASTIC in 1 CARTON (51754-6015-3) / 5 mL in 1 SYRINGE, PLASTIC

NDC 51754-6015-03

🏷️ FDA NDC (as labeled) 51754-6015-3 billing pads the package segment with a zero

Rx only Brand On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

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

FDA NDC (as labeled) 51754-6015-3

Product NDC 51754-6015

11-digit billing NDC 51754601503

NCPDP billing unit ML — per mL (volume)

RxCUI 1731582, 1731590, 2371710, 2371715, 2371718, 2371796, 2473383, 2473384

UNII V92SO9WP2I

Application # NDA210997

SPL Set ID 2189f3f5-39dc-4e85-b7c6-9515ded59686

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 2020-06-01

Route INTRAMUSCULAR, INTRAVENOUS

Dosage form INJECTION, SOLUTION

Substance GLYCOPYRROLATE

GPI-14 4910203000E544

GPI class Glyrx-PF

GCN Seq No 081886

GCN 49145

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 GLYRX-PF 1 MG/5 ML SYRINGE

FDB brand name Glyrx-Pf

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 51754-6015-3 — a 5-4-1 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 package segment → 51754-6015-03. 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

LabelerExela Pharma Sciences, LLC

Application holderEXELA PHARMA SCIENCES LLC

FDA applicationNDA210997 (NDA)

Labeler code51754

First marketedJun 2020

Product typeHuman Prescription Drug

Portfolio24 products on file

🔎 All NDCs from Exela Pharma Sciences, LLC

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 GLYRX-PF 1 MG/5 ML SYRINGE Ingredient Glycopyrrolate/Pf

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Glycopyrrolate — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Glycopyrrolate (46 interactions) — ranked by severity →

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 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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.

2 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 system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	$1.19	$59.62 / 50 ml
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1597	$1.317 / J1597 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)51754-6015-3

11-digit billing NDC51754-6015-03

Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)

HCPCS J-codeJ1597

DescriptorINJECTION, GLYCOPYRROLATE (GLYRX-PF), 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Glycopyrrolate .2 mg/mL 00143-9682-25	Hikma	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 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 63323-0578-01	Fresenius	25 vials	$1.481	AP	Availability likely	—
Glycopyrrolate .2 mg/mL 65219-0801-01	Fresenius	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 72572-0226-25	Civica,	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 00781-3825-96	Sandoz	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 70700-0165-25	Xiromed	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/mL 25021-0796-01	Sagent	10 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 43547-0543-25	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 00517-4601-25	American	25 vials	$1.481	AP	Availability likely	—
Glyrx-Pf .2 mg/mLthis 51754-6015-03	Exela	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	—
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 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 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 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	—
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 51662-1425-01	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

🏛️

2020

On the market since

Jun 2020

📍

2026

Currently FDA-listed

6 years listed

🔓

Generic versions listed

see equivalents

✅Generic appears available

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

Where does this data come from?

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

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 51754-6015-03, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

Units reimbursed last 4 qtrs

204

Gross reimbursed last 4 qtrs

$243.23

Avg / prescription

$3.08

Avg / unit

$1.1952

Latest quarter Q4 2025

11Rx

Fee-for-service vs managed care ⓘ

20% FFS 80% MCO

Fee-for-service · 16 Rx Managed care · 63 Rx

State Medicaid map

Units reimbursed · per 100k residents

0.11.3

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Pennsylvania 1.3 /100k

2 California 0.1 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Glycopyrrolate (matched by generic name) — 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. CMS lists 3 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
51754-6015-03 You're viewing this	10 SYRINGE, PLASTIC in 1 CARTON (51754-6015-3) / 5 mL in 1 SYRINGE, PLASTIC	2020-06-01	Active

🧭 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)	✓ Available

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Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 51754-6015-3, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 51754-6015-03, written without dashes as 51754601503. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 51754-6015-03, the first segment (51754) is the labeler code FDA assigned to Exela Pharma Sciences, LLC; the middle segment (6015) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.

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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 Exela Pharma Sciences, LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

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Does this product have a billing J-code?

Yes — this NDC cross-references HCPCS code J1597 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.

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📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions ⚠️ Warnings 🤒 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

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE GLYRX ® -PF is indicated: 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. in peptic ulcer (adults) • To reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. • Limitations of Use GLYRX-PF is not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.

GLYRX ® -PF 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) • To reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. • Limitations of Use GLYRX-PF is not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION GLYRX ® -PF may be administered intramuscularly (IM), or intravenously (IV), with or without dilution, in the following indications. ( 2.1 ): 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: GLYRX ® -PF is not indicated for the treatment of peptic ulcer in pediatric patients

2.1General Dosage and Administration Information • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. • GLYRX ® -PF may be administered intramuscularly or intravenously, with or without dilution.

2.2Dosing in Adults Preanesthetic Medication The recommended dose of GLYRX ® -PF 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 GLYRX ® -PF 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 GLYRX ® -PF is 0.2 mg for each 1 mg of neostigmine or 5 mg of pyridostigmine. In order to minimize 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 GLYRX ® -PF 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 GLYRX ® -PF 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. Intraoperative Medication Because of the long duration of action of GLYRX ® -PF if used as preanesthetic medication, additional GLYRX ® -PF 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.

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 pediatric dose of GLYRX ® -PF is 0.2 mg for each 1 mg of neostigmine or 5 mg of pyridostigmine. In order to minimize the appearance of cardiac side effects, the drugs may be administered simultaneously by intravenous injection a…

💊 Dosage Forms and Strengths 71 words ▾

3 DOSAGE FORMS AND STRENGTHS GLYRX ® -PF (glycopyrrolate injection) is a clear, colorless, solution for injection available as 0.2 mg/mL and 0.4 mg/2 mL (0.2 mg/mL) single-dose vials and as a 0.6 mg/3 mL and 1 mg/5 mL (0.2 mg/mL) single-dose prefilled syringe. Injection: 0.2 mg/mL and 0.4 mg/2 mL (0.2 mg/mL) single-dose vial and 0.6 mg/3 mL and 1 mg/5 mL (0.2 mg/mL) single-dose prefilled syringe. ( 3 )

⛔ Contraindications 137 words ▾

4 CONTRAINDICATIONS GLYRX ® -PF is contraindicated in: • patients with known hypersensitivity to glycopyrrolate 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 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 GLYRX ® -PF. ( 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 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 GLYRX ® -PF 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 GLYRX ® -PF (due to decreased sweating), particularly in children and the elderly. Advise patients to avoid exertion and high environmental temperature after receiving GLYRX ® -PF.

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 GLYRX ® -PF is inappropriate and possibly harmful. Avoid use in patients with these conditions.

5.5Tachycardia Investigate any tachycardia before giving GLYRX ® -PF because an increase in the heart rate may occur. Use with caution in patients with coronary artery disease, congestive heart failure, cardiac arrhythmias, hypertension, 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 Clinical Pharmacology ( 12.3 ) ].

5.7Autonomic Neuropathy, Hepatic Disease, Ulcerative Colitis, Prostatic Hypertrophy, or Hiatal Hernia Use GLYRX ® -PF 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 anticholinergic drugs, including GLYRX ® -PF, in the treatment of peptic ulcer may produce a delay in gastric emptying/gastric stasis. Monitor patients for symptoms such as vomiting, dyspepsia, early satiety, abdominal distention, and increased abdominal pain. Discontinue GLYRX ® -PF 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 GLYRX ® -PF.

⚠️ Warnings 48 words ▾

🤒 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 reactions 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 Exela Pharma Sciences, LLC at 1-888-451-4321 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 114 words ▾

7 DRUG INTERACTIONS The concurrent use of GLYRX ® -PF 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 GLYRX ® -PF 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 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 640-times and 10-times the maximum recommended human dose (MRHD) of 1 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 640 times the maximum recommended daily human dose of 1 mg on a mg/m 2 basis) and rabbits at intramuscular doses of up to 0.5 mg/kg/day (exposure was approximately 10 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 spas…

🤰 Pregnancy ~2 min read ▾

🧒 Pediatric Use 100 words ▾

A paradoxical reaction characterized by hyperexcitability may occur in pediatric patients receiving large doses of anticholinergics including GLYRX ® -PF. Infants and young children are especially susceptible to the toxic effects of anticholinergics.

🧓 Geriatric Use 84 words ▾

8.5Geriatric Use Clinical Studies of GLYRX ® -PF 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 post dose 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. Group t 1/2 V ss CL T max C max AUC (hr) (L/kg) (L/kg/hr) (min) (µg/L) (µg/L•hr) (6 µg/kg IV) 0.83 ± 0.27 0.42 ± 0.22 0.54 ± 0.14 – – 8.64 ± 1.49 0-8 hr (8 µg/kg IM) – – – 27.48 ± 6.12 3.47 ± 1.48 6.64 ±

2.33Specific Populations Pediatric Patients: Following IV administration (5 μg/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-μg/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-μg/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 ▾

📦 How Supplied / Storage and Handling 85 words ▾

16 HOW SUPPLIED, STORAGE AND HANDLING GLYRX ® -PF (glycopyrrolate injection) is available in: 0.2 mg/mL single-dose vials packaged in 25s (NDC 51754-6000-4) 0.4 mg/2 mL (0.2 mg/mL) single-dose vials packaged in 25s (NDC 51754-6001-4) 0.6 mg/3 mL (0.2 mg/mL) single-dose prefilled disposable syringes packaged in 10s (NDC 51754-6013-3) 1 mg/5 mL (0.2 mg/mL) single-dose prefilled disposable syringes packaged in 10s (NDC 51754-6015-3) Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].

📋 Description 161 words ▾

11 DESCRIPTION GLYRX ® -PF is a synthetic anticholinergic agent. It is intended for intramuscular or intravenous administration. Each 1 mL of GLYRX ® -PF contains 0.2 mg of glycopyrrolate, water for injection, sodium chloride as a tonicity agent, and hydrochloric acid or sodium hydroxide as pH adjusters.

GLYRX ® -PF is preservative free. Glycopyrrolate is a quaternary ammonium salt with the following chemical name: ( RS )-[3-( SR )-Hydroxy-1,1-dimethylpyrrolidinium bromide] α-cyclopentylmandelate. The molecular formula is C 19 H 28 BrNO 3 and the molecular weight is 398.34.

Glycopyrrolate 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 is completely ionized at physiological pH values.

GLYRX ® -PF is a clear, colorless, sterile liquid with a pH of 2.0 – 3.0. The partition coefficient of Glycopyrrolate in n-octanol/water system is 0.304 (log 10 P = -1.52) at ambient room temperature (24°C). Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Drowsiness or Blurred Vision : Inform patients that GLYRX ® -PF 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 GLYRX ® -PF (due to decreased sweating), particularly in children and the elderly.

Advise patients to avoid exertion and high environmental temperature after receiving GLYRX ® -PF [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 GLYRX ® -PF [see Warnings and Precautions ( 5.9 )] . Drug Interactions : Inform patients that GLYRX ® -PF may interact with other drugs.

Advise patients to report to their healthcare provider the use of any other medication [see Drug Interactions ( 7 ) ]. Manufactured and Distributed by : Exela Pharma Sciences, LLC Lenoir, NC 28645 Logo

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vivo: In a living person or animal rather than in a laboratory dish.

sedative: A substance with a calming effect that can also cause drowsiness.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

arrhythmia: A heartbeat that is too fast, too slow, or irregular instead of steady.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

cardiac arrest: A sudden stop of the heart's pumping that cuts off blood flow to the body, which is a medical emergency.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

colitis: Swelling and irritation of the inner lining of the large intestine, or colon.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

edema: Swelling caused by extra fluid trapped in the body's tissues.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

glaucoma: An eye condition, often linked to high pressure inside the eye, that can slowly damage vision.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hyperthyroidism: A condition where the thyroid gland makes too much thyroid hormone, which can speed the body up.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

ileus: A slowdown or stop in the normal movement of the intestines, so food and waste do not pass through.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intramuscular: An injection given deep into a muscle; often written as IM.

intraocular pressure: The fluid pressure inside the eye.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

lactation: The making and release of milk from a mother's breasts after giving birth.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

monotherapy: Treatment using a single medicine by itself.

myasthenia gravis: A long-term condition where muscles tire and grow weak easily, often affecting the eyes, face, and swallowing.

mydriasis: Widening of the pupil, the dark center of the eye.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

parenteral: Given by injection or drip into the body rather than swallowed by mouth.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

photophobia: Discomfort or pain in the eyes when exposed to light.

pruritus: Itching of the skin.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

restlessness: An inability to stay calm or still, with a constant feeling of needing to move.

single-dose vial: A small container holding one dose of medicine, meant to be used once and then thrown away.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

ventricular fibrillation: A life-threatening, chaotic rhythm in the heart's lower chambers that stops the heart from pumping blood effectively.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

xerostomia: Dry mouth caused by too little saliva.

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

← 51754-6013-03 · Exela 51754-8020-04 · Exela →

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.

GLYRX-PF glycopyrrolate .2 mg/mL Injection, Solution

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