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Medicine

Glycopyrrolate 0.2 mg/1 mL injection

Glycopyrrolate · Intramuscular, intravenous
Available on requestPrescription onlyUS FDAGeneric name

Glycopyrrolate 0.2 mg/1 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 25 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 20° to 25°C (68° to 77°F).

Key facts

Active ingredient (INN)
Glycopyrrolate
Brand
Sold under the generic name
Strength
0.2 mg/1 mL
Dosage form
Injection
Route
Intramuscular, intravenous
Packs
25 vials of 1 mL, 5 cartons of 1 mL, 24 blister pack of 1 mL and 43 more
Manufacturers
Accord HealthcareIndiaAlembic PharmaceuticalsIndiaAuroMedics PharmaIndiaCaplin SterilesIndiaGland PharmaIndiaLifestar PharmaIndiaPiramal Critical CareIndiaMedical Purchasing SolutionsFresenius KabiHenry Schein25 labelers on the register
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
A03AB02 Glycopyrrolate
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
30 September 1990
Identifiers
RxCUI 238212, 1731582, 1731590 +2DailyMed set ID eaebb511-1738-4d11-b9bb-317a8d41316a, 250eeef7-b1a9-45e7-a927-7807232e10be, 02f914a8-2356-4525-91ff-cf0c9e41ba23 +37NDC 55150-292, 65219-801, 71288-414 +37Application ANDA210244, ANDA209328, ANDA212802 +18

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

A sample of 41 packs from 25 labelers. The register lists 46 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose16729-471-08Accord HealthcareIndia17 December 2020
25 vial in 1 carton / 1 mL in 1 vial62332-607-25Alembic PharmaceuticalsIndia26 October 2022
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose55150-292-01AuroMedics PharmaIndia28 November 2018
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose65145-102-25Caplin SterilesIndia25 January 2025
25 vial in 1 carton / 1 mL in 1 vial68083-376-25Gland PharmaIndia9 October 2019
5 carton in 1 carton / 25 vial in 1 carton / 1 mL in 1 vial70756-631-05Lifestar PharmaIndia28 February 2023
25 vial, glass in 1 carton / 1 mL in 1 vial, glass66794-202-42Piramal Critical CareIndia11 July 2019
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose63323-578-01Fresenius Kabi27 October 2017
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose63323-578-11Fresenius Kabi27 October 2017
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose65219-801-01Fresenius Kabi31 December 2023
24 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 1 mL in 1 syringe, glass76045-203-10Fresenius Kabi25 July 2018
24 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 1 mL in 1 syringe, glass76045-206-10Fresenius Kabi30 October 2020
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose0143-9587-25Hikma Pharmaceuticals1 June 2015
25 vial in 1 carton / 1 mL in 1 vial0143-9682-25Hikma Pharmaceuticals21 September 2011
10 syringe, glass in 1 carton / 1 mL in 1 syringe, glass0641-6212-10Hikma Pharmaceuticals28 August 2025
25 vial in 1 carton / 1 mL in 1 vial70121-1394-5Amneal Pharmaceuticals15 June 2017
10 syringe, glass in 1 carton / 1 mL in 1 syringe, glass70121-1698-7Amneal Pharmaceuticals25 October 2022
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose71288-414-03Meitheal Pharmaceuticals6 July 2021
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose71288-414-92Meitheal Pharmaceuticals6 July 2021
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose43547-543-25Solco Healthcare20 March 2019
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose43547-639-25Solco Healthcare1 May 2021
25 vial in 1 carton / 1 mL in 1 vial70069-011-25Somerset Therapeutics29 January 2022
25 vial in 1 carton / 1 mL in 1 vial70069-617-25Somerset Therapeutics31 July 2024
25 vial in 1 carton / 1 mL in 1 vial70700-165-25Xiromed9 September 2020
1 vial in 1 carton / 1 mL in 1 vial70700-264-22Xiromed23 October 2023
25 vial, single-dose in 1 tray / 1 mL in 1 vial, single-dose0517-4601-25American Regent30 September 1990
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose71839-123-25BE Pharmaceuticals10 March 2022
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose75834-193-25Nivagen Pharmaceuticals25 October 2021
10 vial in 1 carton / 1 mL in 1 vial25021-796-01Sagent Pharmaceuticals15 October 2024
25 vial in 1 carton / 1 mL in 1 vial0781-3825-96Sandoz22 July 2019
1 vial in 1 bag / 1 mL in 1 vial71872-7093-1Medical Purchasing Solutions30 March 2018
1 vial, glass in 1 bag / 1 mL in 1 vial, glass71872-7174-1Medical Purchasing Solutions15 July 2019
1 vial in 1 bag / 1 mL in 1 vial71872-7181-1Medical Purchasing Solutions6 November 2019
1 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose71872-7208-1Medical Purchasing Solutions30 March 2020
1 vial in 1 bag / 1 mL in 1 vial71872-7224-1Medical Purchasing Solutions17 September 2020
1 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose71872-7238-1Medical Purchasing Solutions28 January 2021
1 vial in 1 bag / 1 mL in 1 vial0404-9775-01Henry Schein16 October 2025
1 vial, glass in 1 bag / 1 mL in 1 vial, glass0404-9776-05Henry Schein5 November 2025
1 vial, glass in 1 bag / 1 mL in 1 vial, glass0404-9777-20Henry Schein5 November 2025
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose72572-225-25Civica10 December 2019
1 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose0404-9782-02—8 May 2025

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 11 August 1961Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Alternatives

Other makers and brands of Glycopyrrolate 0.2 mg/1 mL injection.

Compare all 2

Other strengths and forms of Glycopyrrolate

Clinical summary

Glycopyrrolate is an anticholinergic indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer, among other approved uses. MedsAcross supplies Glycopyrrolate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Glycopyrrolate

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Glycopyrrolate 0.2 mg/1 mL injection for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.