Medicine
Acetaminophen 500 mg/50 mL injection
Acetaminophen 500 mg/50 mL injection is a generic prescription medicine for intravenous use, made by 3 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
Do not freeze. Store at 20° to 25°C (68° to 77°F), excursions permitted…
Key facts
- Active ingredient (INN)
- Acetaminophen
- Brand
- Sold under the generic name
- Strength
- 500 mg/50 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 24 bags of 50 mL, 24 containers of 50 mL, 10 bags of 50 mL and 1 more
- Manufacturers
- Gland PharmaIndiaB. Braun MedicalSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N02BE01 Acetaminophen
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 February 2021
- Identifiers
- RxCUI 483017, 2480095DailyMed set ID 621282f6-75b3-401b-8e1a-c5153a0c9ecd, 9744d804-2857-47ef-a27a-bca27db9394c, db5d4cf8-762a-4111-971e-91c704bc3643 +1NDC 25021-705, 0264-4050, 68083-647Application ANDA219215, NDA204957
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 |
|---|---|---|---|
| 24 bag in 1 carton / 50 mL in 1 bag | 68083-647-01 | Gland PharmaIndia | 2 April 2025 |
| 24 container in 1 case / 50 mL in 1 container | 0264-4050-80 | B. Braun Medical | 18 February 2021 |
| 24 container in 1 case / 50 mL in 1 container | 0264-4050-90 | B. Braun Medical | 10 October 2023 |
| 10 bag in 1 carton / 50 mL in 1 bag | 25021-705-82 | Sagent Pharmaceuticals | 15 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 7 November 1968 | 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 Acetaminophen
Clinical summary
Acetaminophen is a prescription medicine indicated for the management of mild to moderate pain in adult, among other approved uses. It is available as injection for intravenous use. MedsAcross supplies Acetaminophen 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 AcetaminophenFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Acetaminophen prescribing information (Fresenius Kabi) · U.S. National Library of Medicine, DailyMed
Need Acetaminophen 500 mg/50 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.