Medicine
Diphenhydramine 50 mg/1 mL injection
Diphenhydramine 50 mg/1 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 17 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˚-25˚C (68˚-77˚F), excursions permitted to 15˚-30˚C (59˚-86˚F).
Key facts
- Active ingredient (INN)
- Diphenhydramine
- Brand
- Sold under the generic name
- Strength
- 50 mg/1 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 10 ampules of 1 mL, 1 vial of 1 mL, 5 vials of 1 mL and 31 more
- Manufacturers
- Micro LabsIndiaAvet PharmaceuticalsIndiaGland PharmaIndiaFresenius KabiRemedyrepackMedical Purchasing SolutionsArmas PharmaceuticalsCardinal HealthHealth FirstHealthFirst
- Origin register
- US FDA, United States
- Storage
- Store at 20˚-25˚C (68˚-77˚F), excursions permitted to 15˚-30˚C (59˚-86˚F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D04AA32 Diphenhydramine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 November 1972
- Identifiers
- RxCUI 1723740, 1049289, 1049633DailyMed set ID 6671c8d0-1f5d-0d77-e053-2a91aa0a7585, 6d1aa0e2-036d-4382-a458-fc0300dba7cb, 5af966ae-535b-492b-ba2c-eeb4e40be959 +25NDC 71872-7005, 76045-102, 50090-1841 +26Application ANDA080817, ANDA091526, ANDA040466 +3
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 ampule in 1 carton / 1 mL in 1 ampule | 42571-169-55 | Micro LabsIndia | 4 December 2018 |
| 1 vial in 1 carton / 1 mL in 1 vial | 42571-337-56 | Micro LabsIndia | 5 March 2026 |
| 5 vial in 1 carton / 1 mL in 1 vial | 42571-337-78 | Micro LabsIndia | 3 March 2026 |
| 25 vial in 1 carton / 1 mL in 1 vial | 42571-337-87 | Micro LabsIndia | 10 December 2019 |
| 25 vial, glass in 1 package / 1 mL in 1 vial, glass | 23155-264-41 | Avet PharmaceuticalsIndia | 30 June 2025 |
| 25 vial in 1 carton / 1 mL in 1 vial | 68083-611-25 | Gland PharmaIndia | 20 March 2024 |
| 25 vial, single-dose in 1 tray / 1 mL in 1 vial, single-dose | 63323-664-01 | Fresenius Kabi | 1 August 2002 |
| 25 vial in 1 tray / 1 mL in 1 vial | 63323-664-16 | Fresenius Kabi | 1 August 2002 |
| 25 vial, single-dose in 1 tray / 1 mL in 1 vial, single-dose | 65219-820-01 | Fresenius Kabi | 5 May 2025 |
| 24 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 1 mL in 1 syringe, glass | 76045-102-10 | Fresenius Kabi | 26 March 2013 |
| 24 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 1 mL in 1 syringe, glass | 76045-235-10 | Fresenius Kabi | 2 June 2025 |
| 25 vial in 1 package / 1 mL in 1 vial | 0641-0376-25 | Hikma Pharmaceuticals | 27 November 1972 |
| 25 vial in 1 package / 1 mL in 1 vial | 0641-6282-25 | Hikma Pharmaceuticals | 27 November 1972 |
| 5 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 72485-101-05 | Armas Pharmaceuticals | 5 May 2023 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 72485-101-25 | Armas Pharmaceuticals | 1 May 2019 |
| 1 mL in 1 vial | 51662-1219-1 | Health First | 16 August 2018 |
| 25 pouch in 1 case / 1 mL in 1 pouch | 51662-1219-3 | Health First | 15 June 2020 |
| 25 vial in 1 carton / 1 mL in 1 vial | 25021-481-01 | Sagent Pharmaceuticals | 15 January 2025 |
| 25 vial in 1 package / 1 mL in 1 vial | 70518-1082-1 | Remedyrepack | 27 March 2018 |
| 25 vial in 1 package / 1 mL in 1 vial | 70518-4455-0 | Remedyrepack | 23 August 2025 |
| 25 vial, glass in 1 package / 1 mL in 1 vial, glass | 70518-4536-0 | Remedyrepack | 18 December 2025 |
| 25 vial in 1 carton / 1 mL in 1 vial | 70518-4765-1 | Remedyrepack | 25 September 2026 |
| 1 vial in 1 bag / 1 mL in 1 vial | 71872-7005-1 | Medical Purchasing Solutions | 28 February 2018 |
| 1 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose | 71872-7180-1 | Medical Purchasing Solutions | 9 October 2019 |
| 1 vial, glass in 1 bag / 1 mL in 1 vial, glass | 71872-7373-1 | Medical Purchasing Solutions | 13 May 2026 |
| 5 vial in 1 bag / 1 mL in 1 vial | 55154-5102-5 | Cardinal Health | 28 June 2011 |
| 5 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose | 55154-9363-5 | Cardinal Health | 1 August 2002 |
| 1 mL in 1 vial | 51662-1348-1 | HealthFirst | 26 November 2018 |
| 25 pouch in 1 box / 1 vial, single-dose in 1 pouch / 1 mL in 1 vial, single-dose | 51662-1374-3 | HealthFirst | 1 August 2002 |
| 25 vial in 1 package / 1 mL in 1 vial | 50090-1841-0 | A-S Medication Solutions | 21 May 2015 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 83634-781-01 | Avenacy | 1 September 2025 |
| 1 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose | 0404-9851-01 | Henry Schein | 17 January 2022 |
| 1 mL in 1 vial, single-dose | 84549-101-25 | ProPharma Distribution | 27 August 2025 |
| 25 vial in 1 package / 1 mL in 1 vial | 85766-253-25 | Sportpharm | 23 July 2026 |
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 4 March 1946 | 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 Diphenhydramine
Clinical summary
Diphenhydramine is a histamine-1 receptor antagonist. It is available as injection and oral solution for intramuscular and intravenous use. MedsAcross supplies Diphenhydramine 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 DiphenhydramineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Diphenhydramine HCL prescribing information (Redmont Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Diphenhydramine 50 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.