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Glycopyrrolate .2 mg/mL Injection, Solution — NDC 66794-0205-41 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Glycopyrrolate .2 mg/mL Injection, Solution — NDC 66794-205-41 (Billing 66794-0205-41)

by Piramal Critical Care Inc · 10 VIAL, GLASS in 1 CARTON / 20 mL in 1 VIAL, GLASS

This is a package of Glycopyrrolate .2 mg/mL Injection, Solution from Piramal Critical Care Inc, marketed since Jul 2019 and currently FDA-listed. It is this product's only package size.

NDC 66794-0205-41
🏷️ FDA NDC (as labeled) 66794-205-41 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 66794-205-41 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
66794 labeler · 205 product · 41 package
Package marketed since
Jul 11, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6679420541 1
Medicaid fills, this package
32 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Glycopyrrolate (different manufacturers) — 4 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 16, 2026 — Presence of Particulate Matter: Hair was found in product (Fresenius Kabi USA, LLC) · FDA recall D-0725-2026
Class II · Jul 14, 2026 — Failed Impurities/Degradation Specifications (Precision Dose Inc.) · FDA recall D-0741-2026
Class III · Dec 15, 2025 — Failed Impurities/Degradation Specifications (NOVADOZ PHARMACEUTICALS LLC) · FDA recall D-0300-2026
Class II · Dec 16, 2022 — Failed Impurities/Degradation Specifications (Aurolife Pharma, LLC) · FDA recall D-0087-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 66794-205-41
Product NDC 66794-205
11-digit billing NDC 66794020541
NCPDP billing unit ML — per mL (volume)
RxCUI 238212, 1731582, 1731590
UNII V92SO9WP2I
Application # ANDA210842
SPL Set ID 83d70378-011b-4ce3-e053-2991aa0a22be
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 2019-07-11
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance GLYCOPYRROLATE
TE code (Orange Book) AP · RLD · RS

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

GPI-14 49102030002014
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 4 MG/20 ML VIAL
FDB brand name Glycopyrrolate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004886
  • GCN: 19121
  • GPI-14 (Medi-Span): 49102030002014
  • HICL (First Databank): 002028
  • AHFS class code: 12:08.08.00
  • RxCUI (RxNorm): 238212
Why two NDCs? The FDA registers this code as 66794-205-41 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 66794-0205-41. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Anticholinergic class.

Pharmacologic class Anticholinergic, Cholinergic Muscarinic Antagonist
Drug family (ATC) Antihidrotics
How it works Cholinergic Muscarinic Antagonists, Cholinergic Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name GLYCOPYRROLATE 4 MG/20 ML VIAL Ingredient Glycopyrrolate
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $3.37 $674.50 / 200 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1596 $0.365 / J1596 unit —
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)66794-205-41
11-digit billing NDC66794-0205-41
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1596
DescriptorINJECTION, GLYCOPYRROLATE, 0.1 MG
Billing units / pkg2 units
How the units are derivedThis package is 20 ML; the HCPCS unit is 0.1 MG, so one package = 2 billing units.
Medicare Part B spend (2026 (Q1))$241 · 54 claims · $4.46 per claim (all NDCs under J1596)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
66794-0205-41 You're viewing this Main listing 10 VIAL, GLASS in 1 CARTON / 20 mL in 1 VIAL, GLASS 2019-07-11 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Glycopyrrolate .2 mg/mL 25021-0796-01 Sagent 10 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 63323-0578-01 Fresenius 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 00143-9682-25 Hikma 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 70069-0011-25 Somerset 25 vials $1.514 AP Availability likely —
glycopyrrolate .2 mg/mL 71839-0123-25 BE 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 72572-0225-25 Civica, 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 65219-0801-01 Fresenius 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 71288-0414-03 Meitheal 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 72572-0226-25 Civica, 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 43547-0639-25 Solco 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 00781-3825-96 Sandoz 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 66794-0202-42 Piramal 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 70700-0165-25 Xiromed 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 65145-0102-25 Caplin 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 70069-0617-25 Somerset 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 43547-0543-25 Solco 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 62332-0607-25 Alembic 25 vials $1.514 AP Availability likely —
Glycopyrrolate .2 mg/mL 00517-4601-25 American 25 vials $1.514 AP Availability likely —
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 00143-9679-10 Hikma 10 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 00143-9680-25 Hikma 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 00404-9776-05 Henry 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 00404-9777-20 Henry 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 00517-4605-25 American 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 00517-4620-25 American 25 vials — AP FDA listed —
Glycopyrrolate 1 mg/5mL 00781-3829-96 Sandoz 25 vials — AP FDA listed —
Glycopyrrolate 4 mg/20mL 00781-3831-95 Sandoz 10 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 16729-0473-03 Accord 10 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 16729-0474-03 Accord 10 vials — AP FDA listed —
Glycopyrrolate 1 mg/5mL 51662-1431-01 HF 5 ml — AP FDA listed —
Glycopyrrolate .2 mg/mL 51662-1484-01 HF 20 ml — AP FDA listed —
Glycopyrrolate .2 mg/mL 51662-1601-01 HF 5 ml — AP 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 62332-0628-25 Alembic 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 62332-0629-10 Alembic 10 vials — AP FDA listed —
Glycopyrrolate 1 mg/5mL 65145-0104-25 Caplin 25 vials — AP FDA listed —
Glycopyrrolate 4 mg/20mL 65145-0105-10 Caplin 10 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 66794-0204-42 Piramal 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mLthis 66794-0205-41 Piramal 10 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 68083-0378-25 Gland 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 68083-0379-10 Gland 10 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 70069-0616-10 Somerset 10 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 70069-0619-25 Somerset 25 vials — AP FDA listed —
Glycopyrrolate 1 mg/5mL 70121-1396-05 Amneal 25 vials — AP FDA listed —
Glycopyrrolate 4 mg/20mL 70121-1397-07 Amneal 10 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 70700-0167-25 Xiromed 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 70700-0168-23 Xiromed 10 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 70700-0902-25 Xiromed, 25 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 70700-0903-23 Xiromed, 10 vials — AP FDA listed —
Glycopyrrolate .2 mg/mL 70756-0633-25 Lifestar 25 vials — — FDA listed —
Glycopyrrolate .2 mg/mL 70756-0634-10 Lifestar 10 vials — — FDA listed —
Glycopyrrolate .2 mg/mL 71288-0415-06 Meitheal 25 vials — AP FDA listed —
glycopyrrolate 1 mg/5mL 71839-0125-25 BE 25 vials — AP FDA listed —
glycopyrrolate 4 mg/20mL 71839-0126-25 BE 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 4 mg/20mL 71872-7179-01 Medical 1 vial — AP FDA listed —
Glycopyrrolate .2 mg/mL 71872-7196-01 Medical 1 vial — AP FDA listed —
Glycopyrrolate 4 mg/20mL 71872-7289-01 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 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 84549-0204-42 ProPharma 5 ml — AP FDA listed —
Glycopyrrolate .2 mg/mL 84549-0205-41 ProPharma 20 ml — AP FDA listed —
Glycopyrrolate .2 mg/mL 86211-0113-10 Jvet 10 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 00143-9681-25 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 70069-0012-25 Somerset 25 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 1Ml .2 mg/mL 70700-0264-22 XIROMED 1 vial — — 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 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 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 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 70756-0631-25 Lifestar 25 vials — — FDA listed —
Glycopyrrolate .2 mg/mL 70756-0632-25 Lifestar 25 vials — — 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 70121-1699-02 Amneal 12 syringes — 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 70121-1394-05 Amneal 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 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 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 68083-0376-25 Gland 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 51662-1487-01 HF 1 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 76045-0023-30 Fresenius 10 syringes — — FDA listed —
Glycopyrrolate .2 mg/mL 51662-1425-01 HF 1 ml — AP FDA listed —
Glycopyrrolate .2 mg/mL 68083-0377-25 Gland 25 vials — 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

🏛️
2019
On the market since
Jul 2019
📍
2026
Currently FDA-listed
7 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.

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.

  • 9 mg / 1 mL 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 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerPiramal Critical Care Inc
Application holderPIRAMAL CRITICAL CARE INC
FDA applicationANDA210842 (ANDA)
Labeler code66794
First marketedJul 2019
Product typeHuman Prescription Drug
Portfolio23 products on file

More NDCs from Piramal Critical Care Inc labeler code 66794

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 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.

( 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 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 )

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.

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 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 ( 2.2 , 2.3 , 2.4 ) 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 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 both 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 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 not constitute an endorsement of the clinical utility or safety of co-administration of Glycopyrrolate Injection with t… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 70 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, 0.2 mg/2 mL single dose vials and 0.2 mg/5 mL, 0.2 mg/20 mL multi-dose vials. Injection: 0.2 mg/mL glycopyrrolate in presentation of 0.2 mg/1 mL, 0.2 mg/2 mL single dose vials and 0.2 mg/5 mL, 0.2 mg/20 mL multiple dose vials. ( 3 )

⛔ Contraindications 136 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, including benzyl alcohol.

(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: Due to its benzyl alcohol content, glycopyrrolate injection should not be used in neonates, i.e., patients less than 1 month of age and avoid use 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.

5.9Light Sensitivity Patients may experience sensitivity of the… [Excerpted — this section continues on DailyMed.]

🤒 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.

The following is discussed in more detail in other sections of the labeling. • Benzyl Alcohol Toxicity : Due to its benzyl alcohol content, glycopyrrolate injection should not be used in neonates, i.e., patients less than 1 month of age [see Warnings and Precautions ( 5.10 ) and Use in Specific Populations ( 8.4 )] . 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 Piramal Critical Care at 1-800-414-1901, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 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. (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 ) See 17 for PATIENT COUNSELING INFORMATION.

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/m2 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/m2 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/m2 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 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… [Excerpted — this section continues on DailyMed.]

🆘 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) (mcg/L) (mcg/L•hr) (6 mcg/kg IV) 0.83 ± 0.27 0.42 ± 0.22 0.54 ± 0.14 - - 8.64 ± 1.49* (8 mcg/kg IM) - - - 27.48 ± 6.12 3.47 ± 1.48 6.64 ± 2.33* * 0 to 8 hr Specific Populations Pediatric Patients Following IV administration (5 mcg/kg glycopyrrolate) to infants and children, the mean t 1/2 values were reported to be between 21.6 and 130.0 minutes and between 19.2 and 99.2 minutes, respectively.

Patients with Renal Impairment In one study glycopyrrolate was administered IV in uremic patients undergoing renal transplantation. The mean elimination half-life was significantly longer (46.8 minutes) than in healthy patients (18.6 minutes). The mean area-under-the-concentration-time curve (10.6 hrmcg/ 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 significantly reduced in patients with renal failure.

12.1Mechanism of Action Glycopyrrolate, like other anticholinergic (antimuscarinic)… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 123 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Glycopyrrolate Injection, USP, 0.2 mg/mL , is a clear colorless solution, and 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 66794-202-02 25 single dose vials in a carton: NDC 66794-202-42 0.2 mg/mL, 2 mL vial Single dose vial: NDC 66794-203-02 25 single dose vials in a carton: NDC 66794-203-42 0.2 mg/mL, 5 mL vial Multiple dose vial: NDC 66794-204-02 25 multiple dose vials in a carton: NDC 66794-204-42 0.2 mg/mL, 20 mL vial Multiple dose vial: NDC 66794-205-02 10 multiple dose vials in a carton: NDC 66794-205-41 Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Discard unused portion.

📋 Description 144 words ▾

11 DESCRIPTION Glycopyrrolate 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.

Its structural formula is as follows: Glycopyrrolate occurs as a white, odorless, crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. It 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 or intravenous administration.

Each 1 mL contains 0.2 mg of glycopyrrolate, water for injection, Benzyl Alcohol, NF 0.9% (preservative) and hydrochloric acid as pH adjusters. Glycopyrrolate Structure

💬 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 for: Piramal Critical Care Bethlehem, PA 18017, USA Product of India Revised: 06/2026 piramal

🧪 Nonclinical Toxicology 157 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis and Impairment of Fertility Carcinogenesis Long-term studies in animals have not been performed to evaluate carcinogenic potential. Mutagenesis Studies to evaluate the mutagenic potential of glycopyrrolate have not been conducted. Impairment of Fertility In reproduction studies in rats, dietary administration of glycopyrrolate resulted in diminished rates of conception in a dose-related manner.

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

13.1Carcinogenesis, Mutagenesis and Impairment of Fertility Carcinogenesis Long-term studies in animals have not been performed to evaluate carcinogenic potential. Mutagenesis Studies to evaluate the mutagenic potential of glycopyrrolate have not been conducted. Impairment of Fertility In reproduction studies in rats, dietary administration of glycopyrrolate resulted in diminished rates of conception in a dose-related manner.

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

📄 Package Label / Principal Display Panel 104 words ▾

NDC 66794-202-02 Glycopyrrolate Injection, USP 1 mL Single Dose Vial NDC 66794-202-42 Glycopyrrolate Injection, USP 25 x 1 mL Single Dose Vials NDC 66794-203-02 Glycopyrrolate Injection, USP 2 mL Single Dose Vial NDC 66794-203-42 Glycopyrrolate Injection, USP 25 x 2 mL Single Dose Vials NDC 66794-204-02 Glycopyrrolate Injection, USP 5 mL Single Dose Vial NDC 66794-204-42 Glycopyrrolate Injection, USP 25 x 5 mL Single Dose Vials NDC 66794-205-02 Glycopyrrolate Injection, USP 20 mL Single Dose Vial NDC 66794-205-42 Glycopyrrolate Injection, USP 10 x 20 mL Single Dose Vials Vial 1 carton 1 vial 2 carton 2 vial 5 carton 5 vial 20 carton 20

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
32
Units reimbursed last 4 qtrs
48
Gross reimbursed last 4 qtrs
$161.88
Avg / prescription
$5.06
Avg / unit
$3.3725
Latest quarter Q1 2026
16Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 32 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 48 units · 1.1 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.11.1
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 Kentucky 1.1 /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 — the program that covers self-administered drugs. 18 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Glycopyrrolate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.44M
Claims incl. refills
67.4K
Beneficiaries
34.1K
Spend / beneficiary
$71.59
Spend / claim
$36.23
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Piramal Critical Care Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Piramal Critical Care Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1596 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 66794-0204-42 · Piramal 66794-0219-43 · Piramal →
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.