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Positive Skin Test Control - Histamine 30 mg/5 mL injection

Histamine · Percutaneous · Jubilant HollisterStier
Available on requestPrescription onlyUS FDA Cold chainIndian manufacturer

Positive Skin Test Control - Histamine 30 mg/5 mL injection is a prescription medicine containing Histamine for percutaneous use, marketed by Jubilant HollisterStier, 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Cold chain

Store at 2°- 8°C. Protect from light when not in use.

Key facts

Active ingredient (INN)
Histamine
Brand
Positive Skin Test Control - Histamine
Strength
30 mg/5 mL
Dosage form
Injection
Route
Percutaneous
Packs
5 mL
Marketing authorisation holder
Jubilant HollisterStier
Manufacturer
Jubilant HollisterStierIndia
Origin register
US FDA, United States
Storage
Store at 2°- 8°C. Protect from light when not in use.
Cold chain
Yes, shipped temperature controlled
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
L03AX14 Histamine
HS code (indicative)
3002.15Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
15 June 1995
Identifiers
DailyMed set ID 5c20f3f4-65f8-4cdb-bdd1-5774da1c551bNDC 65044-9998Application BLA103891

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

PackCodeLabelerMarketed since
5 mL in 1 vial65044-9998-1Jubilant HollisterStierIndia15 June 1995

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 25 April 1939Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
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

Other strengths and forms of Histamine

Clinical summary

Histamine is a prescription medicine indicated as an adjunct in allergy skin test for diagnosis, as a positive control to test wheal-flare response of skin for evaluation of skin test response to allergenic extracts. MedsAcross supplies Histamine 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 Histamine

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

Data sources

Need Positive Skin Test Control - Histamine 30 mg/5 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.