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Glycopyrrolate .2 mg/mL Injection, 25 vials

by Amneal Pharmaceuticals LLC · 25 VIAL in 1 CARTON (70121-1394-5) / 1 mL in 1 VIAL (70121-1394-1)

NDC 70121-1394-05

🏷️ FDA NDC (as labeled) 70121-1394-5 billing pads the package segment with a zero

Rx only Generic On market Non-controlled

🗂️ Data synced Sep 17, 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) 70121-1394-5

Product NDC 70121-1394

11-digit billing NDC 70121139405

NCPDP billing unit ML — per mL (volume)

RxCUI 238212, 1731582, 1731590

UNII V92SO9WP2I

Application # ANDA208973

SPL Set ID bbab4cf1-0441-4fc4-9de9-e4117fa19faa

Established class (EPC) Anticholinergic; Cholinergic Muscarinic Antagonist

Mechanism of action Cholinergic Antagonists; Cholinergic Muscarinic Antagonists

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2017-06-15

Route INTRAMUSCULAR, INTRAVENOUS

Dosage form INJECTION

Substance GLYCOPYRROLATE

GCN Seq No 004886

GCN 19121

HICL code 002028

Ingredient (HICL) Glycopyrrolate

HIC1 code J

Therapeutic class — broad (HIC1) Autonomic Nervous System

HIC2 code J2

Therapeutic class — intermediate (HIC2) Anticholinergics

HIC3 code J2B

Therapeutic class — specific (HIC3) Anticholinergics,Quaternary Ammonium

AHFS code 12:08.08.00

AHFS class Antimuscarinics/Antispasmodics

FDB label name GLYCOPYRROLATE 0.2 MG/ML VIAL

FDB brand name Glycopyrrolate

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AP · RLD · RS

Why two NDCs? The FDA registers this code as 70121-1394-5 — 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 → 70121-1394-05. 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

LabelerAmneal Pharmaceuticals LLC

Application holderAMNEAL EU LTD

FDA applicationANDA208973 (ANDA)

Labeler code70121

First marketedJun 2017

Product typeHuman Prescription Drug

Portfolio472 products on file

🔎 All NDCs from Amneal Pharmaceuticals 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 GLYCOPYRROLATE 0.2 MG/ML VIAL Ingredient Glycopyrrolate

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

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

Where does this data come from?

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

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

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

Price system	Per each	Per 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.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

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.

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

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2017

On the market since

Jun 2017

📍

2026

Currently FDA-listed

9 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

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

Where does this data come from?

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

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

Medicare Part D (outpatient prescription) spending for Glycopyrrolate — the program that covers self-administered drugs. 18 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Glycopyrrolate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$2.44M

Claims incl. refills

67.4K

Beneficiaries

34.1K

Spend / beneficiary

$71.59

Spend / claim

$36.23

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

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

Top reported reactions

Dyspnoea3,566

Cough1,693

Device Delivery System Issue1,666

Death1,631

Asthma1,478

Wrong Technique In Device Usage Process1,317

Chronic Obstructive Pulmonary Disease1,210

Age at onset

Neonate23

Infant13

Child55

Adolescent26

Adult1,670

Elderly2,451

Reporter sex

Male · 43%

Female · 57%

Unknown · 0%

Serious outcomes

Hospitalization4,741

Death2,286

Life-threatening641

Disabling296

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
70121-1394-05 You're viewing this	25 VIAL in 1 CARTON (70121-1394-5) / 1 mL in 1 VIAL (70121-1394-1)	2017-06-15	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	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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 FDA registers it as 70121-1394-5, 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: 70121-1394-05, written without dashes as 70121139405. 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 70121-1394-05, the first segment (70121) is the labeler code FDA assigned to Amneal Pharmaceuticals LLC; the middle segment (1394) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Amneal Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.

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Amneal Pharmaceuticals 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.

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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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Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

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

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 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 Glycopyrrolate injection is an anticholinergic indicated: in anesthesia (adult and pediatric patients) 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. for protection against peripheral muscarinic effects of cholinergic 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 oral medication is not tolerated.

Limitations of Use Glycopyrrolate injection is not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.

1.1Preanesthetic Glycopyrrolate injection is indicated in adults and pediatric patients 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.

1.2Intraoperative Glycopyrrolate injection is indicated in adults and pediatric patients to counteract surgically or drug-induced or vagal reflex-associated arrhythmias.

1.3Reversal of Neuromuscular Blockade Glycopyrrolate injection is indicated in adults and pediatric patients 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.

1.4Peptic Ulcer Glycopyrrolate injection is indicated in 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 Glycopyrrolate injection is not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION NOTE: CONTAINS BENZYL ALCOHOL [see Use in Specific Populations (8.4)]. Glycopyrrolate injection may be administered intramuscularly (IM), or intravenously (IV) without dilution, in the following indications. ( 2.1 ): Adults ( 2.2 , 2.3 , 2.4, 2.5 ) Preanesthetic Medication: 0.004 mg/kg intramuscularly (IM), given 30 to 60 minutes prior to the anticipated time of induction of anesthesia Intraoperative Medication: single doses of 0.1 mg intravenously (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 intravenously (IV) or intramuscularly (IM) at 4-hour intervals, 3 or 4 times daily Pediatric patients ( 2.2 , 2.3 , 2.4 ) Preanesthetic Medication: 0.004 mg/kg intramuscularly (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 intravenously (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 intravenously (IV) 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

2.1Important Dosage and Administration Instructions 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. This product is for single-dose and multiple - dose.

2.2Recommended Dosage of Preanesthetic Medication in Adults and Pediatric Patients 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. Patients less than 2 years of age may require up to 0.009 mg/kg.

2.3Recommended Dosage as Intraoperative Medication to Counteract Drug-induced or Vagal Reflexes and Their Associated Arrhythmias (e.g., bradycardia) in Adults and Pediatric Patients The recommended adult dose of glycopyrrolate injection is 0.1 mg intravenously. Repeat this dose, as needed, at intervals of 2 to 3 minutes. The recommended pediatric dosage is 0.004 mg/kg intravenously, not to exceed 0.1 mg in a single dose, repeated every 2 to 3 minutes.

Attempt to determine the etiology of the arrhythmia, and perform the surgical or anesthetic manipulations necessary to correct parasympathetic imbalance. 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.

2.4Recommended Dosage for Reversal of Neuromuscular Blockade in Adults and Pediatric Patients The recommended dose of glycopyrrolate injection is 0.2 mg intravenous (IV) 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.

2.5Recommended Dosage for Peptic Ulcer in Adults The recommended dosage 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.

2.6Preparation and Handling Diluent Compatibilities Dextrose 5% and 10% in water, or saline, dextrose 5% in sodium chloride 0.45%, sodium chloride 0.9%, and Ringer’s Injection. Diluent Incompatibilities Lactated Ringer’s solution. Admixture Compatibilities Physical Compatibility This list does…

💊 Dosage Forms and Strengths 71 words ▾

3 DOSAGE FORMS AND STRENGTHS Glycopyrrolate injection, USP is a clear, colorless, solution for injection available as 0.2 mg/mL glycopyrrolate in presentation of 0.2 mg/1 mL, 0.4 mg/2 mL (0.2 mg/mL), 1 mg/5 mL (0.2 mg/mL) and 4 mg/20 mL (0.2 mg/mL) single and multiple-dose vials. Injection: 0.2 mg/mL glycopyrrolate in presentation of 0.2 mg/1 mL, 0.4 mg/2 mL , 1 mg/5 mL and 4 mg/20 mL single-dose and multiple-dose vials.

⛔ Contraindications 129 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 ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Precipitation of Acute Glaucoma : 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 ) Benzyl Alcohol Toxicity: Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. ( 5.10 )

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. Glycopyrrolate is contraindicated 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, or hyperthyroidism.

5.6Risk of Use in Patients with Renal Impairment Renal elimination of glycopyrrolate may be significantly reduced 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 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 anticholinergic drugs, including glycopyrrolate injection, in the treatment of peptic ulcer may produce a delay in gastric emptying due to antral stasis. 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.

5.9 Light Sensitivi…

🤒 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. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For product Inquiry call1-877-835-5472.

🔄 Drug Interactions 106 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. Potassium Chloride in a Wax Matrix : May increase severity of potassium chloride-induced gastrointestinal lesions.

👥 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 available data over decades of use with glycopyrrolate in pregnant women 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 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 to 4% and 15 to 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.

🤰 Pregnancy ~2 min read ▾

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use Glycopyrrolate injection is indicated in pediatric patients: 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 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 Due to its benzyl alcohol content, glycopyrrolate injection should not be used in neonates, i.e., patients less than 1 month of age.

Heat prostration can occur in pediatric patients in the presence of fever, high environmental temperature, and/or during physical exercise with use of anticholinergic agents including glycopyrrolate injection [see Warnings and Precautions ( 5.3 )] . Young pediatric patients (and especially those less than 1 month of age), patients with Down 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 receiving large doses of anticholinergics including glycopyrrolate injection.

Dysrhythmias associated with the use of glycopyrrolate intravenously as a premedicant or during anesthesia have been observed in pediatric patients. The safety and effectiveness of glycopyrrolate injection for treatment of peptic ulcer have not been established in pediatric patients. Benzyl alcohol, a component of glycopyrrolate injection, has been associated with serious adverse events and death, particularly in pediatric patients.

The “gasping syndrome,” (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages > 99 mg/kg/day in neonates and low-birth-weight neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.

Although normal therapeutic doses of this product deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome,” the minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birthweight infants, as well as patients receiving high dosages, may be more likely to develop toxicity. Practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources.

🧓 Geriatric Use 28 words ▾

8.6Renal Impairment Renal elimination of glycopyrrolate may be significantly reduced in patients with renal failure. Dosage adjustments may be necessary [see Clinical Pharmacology ( 12.3 )] .

🆘 Overdosage 199 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 intravenous (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 Intravenous (IV) administration. After Intravenous (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 Intramuscular (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 Intramuscular (IM) dose administered was recovered in urine and the bile as unchanged drug and half the Intramuscular (IM) dose is excreted within 3 hrs. The following table summarizes the mean and standard deviation of pharmacokinetic parameters from a study. Group t 1/2 (hr) V ss (L/kg) CL (L/kg/hr) T max (min) C max (mcg/L) AUC (mcg/L•hr) [6 mcg/kg Intravenous (IV)] 0.83 ± 0.27 0.42 ± 0.22 0.54 ± 0.14 – – 8.64 ± 1.49 * [8 mcg/kg Intramuscular (IM)] – – – 27.48 ± 6.12 3.47 ± 1.48 6.64 ± 2.33 * * 0 to 8 hr Specific Populations Pediatric Patients Following Intravenous (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 Intravenous (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 si…

🧬 Mechanism of Action 86 words ▾

📦 How Supplied / Storage and Handling 109 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Glycopyrrolate Injection USP, 0.2 mg/mL , is supplied as single and multiple-dose vials available in following strengths and package sizes: 0.2 mg/mL, 1 mL vial Single-dose vial: NDC 70121-1394-1 25 single-dose vials in a carton: NDC 70121-1394-5 0.2 mg/mL, 2 mL vial Single-dose vial: NDC 70121-1395-1 25 single-dose vials in a carton: NDC 70121-1395-5 0.2 mg/mL, 5 mL vial Multiple-dose vial: NDC 70121-1396-1 25 multiple-dose vials in a carton: NDC 70121-1396-5 0.2 mg/mL, 20 mL vial Multiple-dose vial: NDC 70121-1397-1 10 multiple-dose vials in a carton: NDC 70121-1397-7 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Discard unused portion.

📋 Description 163 words ▾

11 DESCRIPTION Glycopyrrolate injection, USP is a synthetic anticholinergic agent. It is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C 19 H 28 BrNO 3 and the molecular weight is 398.33 g/mol.

Its structural formula is as follows: C 19 H 28 BrNO 3 MW 398.33 Glycopyrrolate, USP 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.

Glycopyrrolate injection, USP, is a clear, colorless, sterile liquid with a pH of 2.0 to 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). Glycopyrrolate injection, USP, is intended for intramuscular (IM) or intravenous (IV) administration.

Each 1 mL contains 0.2 mg of glycopyrrolate, USP; water for injection; and hydrochloric acid or sodium hydroxide as pH adjusters. Glycopyrrolate injection contains benzyl alcohol, 0.9% (preservative). 1

💬 Information for Patients ~1 min read ▾

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 )]. Benzyl Alcohol Toxicity: Advise patients that exposure to excessive amounts of benzyl alcohol has been associated with toxicity in neonates and an increased incidence of kernicterus in small preterm infants [see Warnings and Precautions ( 5.10 ) and Use in Specific Populations ( 8.4 )]. Manufactured by: Amneal Pharmaceuticals Pvt.

Ltd. Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 07-2026-04

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.

depression: A lasting low mood with loss of interest that affects everyday life.

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

diluent: The liquid used to dissolve or thin a medicine before it is given.

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.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

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.

metabolic acidosis: A condition where too much acid builds up in the body's blood and fluids.

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 ↗

← 70121-1389-07 · Amneal 70121-1395-05 · Amneal →

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.

Glycopyrrolate .2 mg/mL Injection, 25 vials

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