Medicine
Dacarbazine 10 mg/mL powder for injection
Dacarbazine 10 mg/mL powder for injection is a generic prescription medicine for intravenous use, made by 2 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
DACARBAZINE FOR INJECTION, USP is available in the following forms: Product…
Key facts
- Active ingredient (INN)
- Dacarbazine
- Brand
- Sold under the generic name
- Strength
- 10 mg/mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 10 vials
- Manufacturers
- Fresenius KabiMeitheal Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- DACARBAZINE FOR INJECTION, USP is available in the following forms: Product Code Unit of Sale Strength Each 102710 NDC 63323-127-10 Unit of 10 100 mg NDC 63323-127-00 10 mL Single Dose Vial 102820 NDC 63323-128-20 Unit of 10 200 mg NDC 63323-128-00 20 mL Single Dose Vial STORE IN A REFRIGERATOR 2°-8°C (36°-46°F). PROTECT FROM LIGHT.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01AX04 Dacarbazine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 7 September 2001
- Identifiers
- RxCUI 1731338, 1731340DailyMed set ID b6b97e41-5f15-498c-abfb-d8443ea4d216, 64037f45-6245-49f0-9ae8-18d75753ae1fNDC 63323-128, 63323-127, 71288-174Application ANDA075371, ANDA075259
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, single-dose in 1 tray / 10 mL in 1 vial, single-dose | 63323-127-10 | Fresenius Kabi | 7 September 2001 |
| 10 vial, single-dose in 1 tray / 20 mL in 1 vial, single-dose | 63323-128-20 | Fresenius Kabi | 7 September 2001 |
| 10 vial, single-use in 1 carton / 20 mL in 1 vial, single-use | 71288-174-21 | Meitheal Pharmaceuticals | 22 April 2024 |
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 27 May 1975 | 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 Dacarbazine
Clinical summary
Dacarbazine is an alkylating drug indicated in the treatment of metastatic malignant melanoma. It is available as powder for injection for intravenous use. MedsAcross supplies Dacarbazine 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 DacarbazineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Dacarbazine prescribing information (Hikma Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Dacarbazine 10 mg/mL powder for 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.