Medicine
Glycopyrrolate 1 mg/5 mL oral solution
Glycopyrrolate 1 mg/5 mL oral solution is a generic prescription medicine for oral use, made by 13 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 room temperature 20°C to 25°C (68°F to 77°F), excursions permitted to…
Key facts
- Active ingredient (INN)
- Glycopyrrolate
- Brand
- Sold under the generic name
- Strength
- 1 mg/5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 1 bottle, 473 mL, 16 mL and 11 more
- Manufacturers
- Aurobindo PharmaIndiaCamber PharmaceuticalsIndiaGranules IndiaIndiaAtlantic BiologicalsAjenat PharmaceuticalsBionpharmaBryant Ranch PrepackChartwell RXNorthStar RxLLCPar Health
- Origin register
- US FDA, United States
- Storage
- Store at room temperature 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°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
- 4 January 2022
- Identifiers
- RxCUI 999961DailyMed set ID 89090b34-470c-478c-be49-1d2bc48a28f8, 4741be85-3abb-4545-aba9-281f64d210ec, 50b493d7-8e3b-e459-e063-6394a90addbc +10NDC 62135-961, 31722-016, 17856-1016 +10Application ANDA216368, ANDA213698, ANDA220062 +6
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 |
|---|---|---|---|
| 1 bottle in 1 carton / 473 mL in 1 bottle | 59651-435-47 | Aurobindo PharmaIndia | 31 December 2024 |
| 1 bottle in 1 carton / 473 mL in 1 bottle | 31722-016-47 | Camber PharmaceuticalsIndia | 5 July 2022 |
| 473 mL in 1 bottle | 70010-106-44 | Granules IndiaIndia | 19 August 2025 |
| 1 bottle in 1 bottle / 473 mL in 1 bottle | 82983-428-47 | Ajenat Pharmaceuticals | 12 December 2025 |
| 1 bottle in 1 carton / 473 mL in 1 bottle | 69452-406-88 | Bionpharma | 11 May 2026 |
| 473 mL in 1 bottle | 62135-961-47 | Chartwell RX | 11 April 2025 |
| 16 mL in 1 bottle | 49884-042-33 | Par Health | 4 January 2022 |
| 1 bottle in 1 carton / 473 mL in 1 bottle | 70752-175-12 | Quagen Pharmaceuticals | 1 August 2026 |
| 1 bottle in 1 bottle / 473 mL in 1 bottle | 71656-061-16 | Saptalis Pharmaceuticals | 25 November 2024 |
| 120 syringe in 1 case / 2.5 mL in 1 syringe | 17856-1016-1 | Atlantic Biologicals | 30 April 2026 |
| 72 cup, unit-dose in 1 case / 5 mL in 1 cup, unit-dose | 17856-1016-2 | Atlantic Biologicals | 30 April 2026 |
| 473 mL in 1 bottle | 63629-9592-1 | Bryant Ranch Prepack | 12 December 2022 |
| 1 bottle in 1 carton / 473 mL in 1 bottle | 72603-240-01 | NorthStar RxLLC | 10 January 2024 |
| 50 bag in 1 case / 1 syringe, plastic in 1 bag / 5 mL in 1 syringe, plastic | 68094-073-58 | Precision Dose | 7 July 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
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 1 mg/5 mL oral solution 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.