MAL23036017ACZPrescription (MAL-A)

ZACTRO Azithromycin Lyophilized Powder for Solution for Infusion 500mg/vial

Generic Molecule: Azithromycin Monohydrate

ACTIVE & APPROVEDValid till: 2 Mar 2028
NPRA Official Regulatory Summary

ZACTRO Azithromycin Lyophilized Powder for Solution for Infusion 500mg/vial is a KKM-approved Prescription Medicine registered under MAL number MAL23036017ACZ by BioCare Pharmaceutical (M) Sdn. Bhd.. Its active ingredient is Azithromycin Monohydrate 512.02 mg, manufactured by M/s Gland Pharma Limited.

Holder (PRH)
BioCare Pharmaceutical (M) Sdn. Bhd.
Manufacturer
M/s Gland Pharma Limited
First Registered
2 Mar 2023
Validity
2 Mar 2028

Prescription Required (Schedule Poison)

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Active Ingredients & Strength Formulation

1 Component
Active Substance / MoleculeDeclared Strength / DosageGeneric Directory
Azithromycin Monohydrate512.02 mgFind Brands
Dosage values indicate declared active concentration per unit dose as registered with NPRA Malaysia.

Equivalent Registered Brands in Malaysia1 Available

Products sharing identical active ingredient formulation (Azithromycin Monohydrate) approved by NPRA.

View All 1 Brands

Malaysian KKM Security Hologram Verification

FarmaChecker & Meditag™

By Malaysian Ministry of Health (KKM) regulation, all genuine registered pharmaceuticals, health supplements (MAL-N), and traditional products (MAL-T) distributed in Malaysia must feature an official tamper-evident security hologram sticker on the physical packaging.

1. Visual Tilt Check

Tilt the box under light to view the micro-engraved KKM coat of arms and multi-layer iridescent security patterns.

2. Match MAL Number

Ensure the printed MAL code matches MAL23036017ACZ exactly on label and box.

3. FarmaChecker Scan

Scan using the official FarmaChecker app on iOS / Android to authenticate serial token with NPRA servers.

If the packaging lacks a security hologram or fails the FarmaChecker scan, do not consume and report to Cawangan Penguatkuasaan Farmasi (CPF KKM).
Frequently Asked Questions & Verification Details

Is ZACTRO Azithromycin Lyophilized Powder for Solution for Infusion 500mg/vial approved by KKM / NPRA?

Yes. ZACTRO Azithromycin Lyophilized Powder for Solution for Infusion 500mg/vial is actively registered with the National Pharmaceutical Regulatory Agency under official registration number MAL23036017ACZ with current status PRODUCT APPROVED. Registration was filed by BioCare Pharmaceutical (M) Sdn. Bhd..

What are the active ingredients of ZACTRO Azithromycin Lyophilized Powder for Solution for Infusion 500mg/vial?

The declared active therapeutic components are: Azithromycin Monohydrate 512.02 mg. Always follow dosage recommendations prescribed by a certified doctor or licensed pharmacist.

What are the registered generic alternatives in Malaysia?

In Malaysia, there are 2 registered brand formulations containing identical active ingredients (Azithromycin Monohydrate). You can review them in the alternative brands section above or consult your community pharmacist for generic bioequivalent substitution.

Semakan status pendaftaran KKM / NPRA: ZACTRO Azithromycin Lyophilized Powder for Solution for Infusion 500mg/vial (MAL23036017ACZ) | Pengganti ubat di Malaysia | Bahan aktif ubat & maklumat farmasi.