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Medicine

Cyanocobalamin 10000 mcg/10 mL injection

Cyanocobalamin · Intramuscular, subcutaneous
Available on requestPrescription onlyUS FDAGeneric name

Cyanocobalamin 10000 mcg/10 mL injection is a generic prescription medicine for intramuscular, subcutaneous use, made by 8 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

Available on request

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). PROTECT FROM LIGHT Use only if solution is…

Key facts

Active ingredient (INN)
Cyanocobalamin
Brand
Sold under the generic name
Strength
10000 mcg/10 mL
Dosage form
Injection
Route
Intramuscular, subcutaneous
Packs
10 vials of 10 mL, 25 vials of 10 mL, 1 vial of 10 mL and 10 more
Manufacturers
Zydus LifesciencesIndiaLifestar PharmaIndiaGland PharmaIndiaSomerset TherapeuticsAmerican RegentHikma PharmaceuticalsMeitheal PharmaceuticalsPlano Pharmaceuticals
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F). PROTECT FROM LIGHT Use only if solution is clear and seal intact.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
B03BA01 Cyanocobalamin
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
20 October 1971
Identifiers
RxCUI 309594DailyMed set ID 41ac0dc1-0a71-4c69-8e25-ba838f5f16a3, ef300a08-8212-40a9-847a-1b62348896dd, b1e35c97-2157-454e-967f-53a4300827de +6NDC 70069-172, 70771-1689, 70756-636 +6Application ANDA206503, ANDA214655, ANDA217839 +4

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.

PackCodeLabelerMarketed since
10 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose70710-1664-6Zydus LifesciencesIndia5 May 2022
25 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose70710-1664-7Zydus LifesciencesIndia5 May 2022
10 vial, multi-dose in 1 vial / 10 mL in 1 vial, multi-dose70771-1689-6Zydus LifesciencesIndia5 May 2022
25 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose70771-1689-7Zydus LifesciencesIndia5 May 2022
25 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose68083-561-25Gland PharmaIndia14 October 2022
10 vial in 1 carton / 10 mL in 1 vial70756-636-10Lifestar PharmaIndia10 July 2024
25 vial in 1 carton / 10 mL in 1 vial70756-636-25Lifestar PharmaIndia10 July 2024
25 vial, multi-dose in 1 tray / 10 mL in 1 vial, multi-dose0517-0032-25American Regent7 November 1996
10 vial, multi-dose in 1 box / 10 mL in 1 vial, multi-dose0143-9620-10Hikma Pharmaceuticals20 October 1971
10 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose71288-301-11Meitheal Pharmaceuticals15 November 2024
1 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose87188-112-01Plano Pharmaceuticals14 October 2022
10 vial in 1 carton / 10 mL in 1 vial70069-172-10Somerset Therapeutics27 June 2017
25 vial in 1 carton / 10 mL in 1 vial70069-172-25Somerset Therapeutics27 June 2017
10 vial, multi-dose in 1 box / 10 mL in 1 vial, multi-dose69680-113-99—2 January 2019
10 mL in 1 vial, multi-dose51662-1440-1—29 January 2020
1 vial, multi-dose in 1 bag / 10 mL in 1 vial, multi-dose0404-9786-10—6 May 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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 15 September 1949Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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

Alternatives

Other makers and brands of Cyanocobalamin 10000 mcg/10 mL injection.

Compare 1

Other strengths and forms of Cyanocobalamin

Clinical summary

Cyanocobalamin is a vitamin B12 indicated for vitamin B 12 maintenance therapy in adult patients with pernicious anemia, among other approved uses. It is available as injection and nasal spray for intramuscular and subcutaneous use. MedsAcross supplies Cyanocobalamin 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 Cyanocobalamin

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

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