Medicine
Caffeine 20 mg/mL oral solution
Caffeine 20 mg/mL oral solution is a generic prescription medicine for oral use, made by 6 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)
- Caffeine
- Brand
- Sold under the generic name
- Strength
- 20 mg/mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 10 vials, 5 vials and 5 more
- Manufacturers
- Micro LabsIndiaSun Pharmaceutical IndustriesIndiaExela Pharma SciencesArmas PharmaceuticalsFresenius KabiSagent 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
- N06BC01 Caffeine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 21 September 2006
- Identifiers
- RxCUI 849928, 849931DailyMed set ID db4477a3-b291-4b77-9eca-b7ba8f66b2be, b4fb7c77-1e82-48b7-83c5-dd04ec7c5c4e, 2bd238d4-4657-4341-9c28-1b468b8f3bf8 +3NDC 42571-346, 63323-406, 72485-110 +3Application ANDA213202, ANDA078002, ANDA077304 +2
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 |
|---|---|---|---|
| 10 vial in 1 box / 3 mL in 1 vial | 42571-346-69 | Micro LabsIndia | 1 February 2020 |
| 5 vial in 1 box / 3 mL in 1 vial | 42571-346-96 | Micro LabsIndia | 23 April 2026 |
| 10 vial, single-dose in 1 container / 3 mL in 1 vial, single-dose | 47335-290-44 | Sun Pharmaceutical IndustriesIndia | 1 March 2021 |
| 10 vial, single-dose in 1 box / 3 mL in 1 vial, single-dose | 72485-110-10 | Armas Pharmaceuticals | 1 March 2020 |
| 5 vial in 1 carton / 3 mL in 1 vial | 51754-0501-2 | Exela Pharma Sciences | 31 August 2019 |
| 10 vial in 1 carton / 3 mL in 1 vial | 51754-0501-3 | Exela Pharma Sciences | 30 March 2015 |
| 5 vial in 1 carton / 3 mL in 1 vial | 63323-406-03 | Fresenius Kabi | 19 November 2009 |
| 10 vial in 1 carton / 3 mL in 1 vial | 25021-602-03 | Sagent Pharmaceuticals | 15 September 2012 |
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.
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 Caffeine
Clinical summary
Caffeine is a central nervous system stimulant indicated for the treatment of apnea of prematurity. It is available as injection and oral solution for intravenous and intramuscular use. MedsAcross supplies Caffeine 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 CaffeineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Caffeine Citrate prescribing information (Hikma Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Gencebok: European public assessment report (EPAR) · European Medicines Agency
- Peyona (previously Nymusa): European public assessment report (EPAR) · European Medicines Agency
Need Caffeine 20 mg/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.