Medicine
Glycopyrrolate 0.4 mg/2 mL injection
Glycopyrrolate 0.4 mg/2 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 21 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
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
- 0.4 mg/2 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 25 vials of 2 mL, 24 blister pack of 2 mL, 10 syringes of 2 mL and 27 more
- Manufacturers
- Accord HealthcareIndiaAlembic PharmaceuticalsIndiaAuroMedics PharmaIndiaCaplin SterilesIndiaGland PharmaIndiaLifestar PharmaIndiaPiramal Critical CareIndiaFresenius KabiHikma PharmaceuticalsAmneal Pharmaceuticals
- 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 bbab4cf1-0441-4fc4-9de9-e4117fa19faa, 02f914a8-2356-4525-91ff-cf0c9e41ba23, c4c3be3a-ea28-864f-e053-2a95a90a701a +26NDC 70121-1395, 71288-414, 51662-1554 +25Application ANDA208973, ANDA212802, ANDA090963 +17
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 16729-472-08 | Accord HealthcareIndia | 10 December 2020 |
| 25 vial in 1 carton / 2 mL in 1 vial | 62332-627-25 | Alembic PharmaceuticalsIndia | 26 October 2022 |
| 25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 55150-293-02 | AuroMedics PharmaIndia | 28 November 2018 |
| 25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 65145-103-25 | Caplin SterilesIndia | 25 January 2025 |
| 25 vial in 1 carton / 2 mL in 1 vial | 68083-377-25 | Gland PharmaIndia | 9 October 2019 |
| 25 vial in 1 carton / 2 mL in 1 vial | 70756-632-25 | Lifestar PharmaIndia | 28 February 2023 |
| 25 vial, glass in 1 carton / 2 mL in 1 vial, glass | 66794-203-42 | Piramal Critical CareIndia | 11 July 2019 |
| 25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 63323-578-02 | Fresenius Kabi | 27 October 2017 |
| 25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 63323-578-12 | Fresenius Kabi | 27 October 2017 |
| 24 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 2 mL in 1 syringe, glass | 76045-203-20 | Fresenius Kabi | 25 July 2018 |
| 24 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 2 mL in 1 syringe, glass | 76045-208-20 | Fresenius Kabi | 30 October 2020 |
| 25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 0143-9586-25 | Hikma Pharmaceuticals | 1 June 2015 |
| 25 vial in 1 carton / 2 mL in 1 vial | 0143-9681-25 | Hikma Pharmaceuticals | 21 September 2011 |
| 10 syringe, glass in 1 carton / 2 mL in 1 syringe, glass | 0641-6213-10 | Hikma Pharmaceuticals | 28 August 2025 |
| 25 vial in 1 carton / 2 mL in 1 vial | 70121-1395-5 | Amneal Pharmaceuticals | 15 June 2017 |
| 10 syringe, glass in 1 carton / 2 mL in 1 syringe, glass | 70121-1699-7 | Amneal Pharmaceuticals | 25 October 2022 |
| 25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 71288-414-04 | Meitheal Pharmaceuticals | 6 July 2021 |
| 25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 71288-414-94 | Meitheal Pharmaceuticals | 6 July 2021 |
| 25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 43547-544-25 | Solco Healthcare | 20 March 2019 |
| 25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 43547-640-25 | Solco Healthcare | 1 May 2021 |
| 25 vial in 1 carton / 2 mL in 1 vial | 70069-012-25 | Somerset Therapeutics | 29 January 2022 |
| 25 vial in 1 carton / 2 mL in 1 vial | 70069-618-25 | Somerset Therapeutics | 31 July 2024 |
| 25 vial, single-dose in 1 tray / 2 mL in 1 vial, single-dose | 0517-4602-25 | American Regent | 30 September 1990 |
| 25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 71839-124-25 | BE Pharmaceuticals | 10 March 2022 |
| 25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 75834-194-25 | Nivagen Pharmaceuticals | 25 October 2021 |
| 10 vial in 1 carton / 2 mL in 1 vial | 25021-796-02 | Sagent Pharmaceuticals | 15 November 2024 |
| 25 vial in 1 carton / 2 mL in 1 vial | 0781-3827-96 | Sandoz | 22 July 2019 |
| 25 vial in 1 carton / 2 mL in 1 vial | 70700-166-25 | Xiromed | 9 September 2020 |
| 25 pouch in 1 case / 1 vial in 1 pouch / 2 mL in 1 vial | 51662-1554-3 | HealthFirst | 14 June 2021 |
| 2 mL in 1 vial, glass | 84549-203-42 | ProPharma Distribution | 18 September 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 11 August 1961 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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 0.4 mg/2 mL injection.
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 GlycopyrrolateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Glycopyrrolate prescribing information (Rising Pharma Holdings) · U.S. National Library of Medicine, DailyMed
Need Glycopyrrolate 0.4 mg/2 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.