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Vancomycin Hydrochloride for Injection

NAFDAC Reg. No. C4-1494 · Drug

Registered with NAFDAC. Registration activeAs of 27 October 2026 · synced automatically from official sources.
Product
Vancomycin Hydrochloride for Injection
NAFDAC number
C4-1494
Active ingredient
Vancomycin (Vancomycin Hydrochloride)
Strength
500 mg
Form
Powder for injection
Pack size
1 x 10 mL (in glass vial)
Manufacturer
Not listed
Applicant (holder)
Ukanwa Pharmaceutical Company Nigeria Limited
Approved
21 Dec 2020
Status
Inactive View on NAFDAC ↗
Registration valid to
20 Dec 2025
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Vancomycin Hydrochloride for Injection is on the NAFDAC register with an active registration (C4-1494). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.

What Vancomycin Hydrochloride for Injection is used for

From the official U.S. FDA label for vancomycin (vancomycin hydrochloride), the active ingredient registered with NAFDAC.

Boxed warning: POTENTIAL RISK OF EXPOSURE TO EXCIPIENTS DURING THE FIRST OR SECOND TRIMESTER OF PREGNANCY If use of vancomycin is needed during the first or second trimester of pregnancy, use other available formulations of vancomycin. This formulation of vancomycin injection contains the excipients polyethylene glycol (PEG 400) and N-acetyl D-alanine (NADA), which resulted in fetal malformations in animal reproduction studies at dose exposures approximately 8 and 32 times, respectively, higher than the exposu …
What it is used for

Vancomycin Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of: Septicemia ( 1.1 ) Infective Endocarditis ( 1.2 ) Skin and Skin Structure Infections ( 1.3 ) Bone Infections ( 1.4 ) Lower Respiratory Tract Infections ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Injection and other antibacterial drugs, Vancomycin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. …

Possible side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion Reactions [see Warnings and Precautions (5.2) ] Nephrotoxicity [see Warnings and Precautions (5.3) ] Ototoxicity [see Warnings and Precautions (5.4) ] Severe Dermatologic Reactions [see Warnings and Precautions (5.5) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.6) ] Hemorrhagic Occlusive Retinal Vasculitis [see Warnings and Precautions (5.7) ] Neutropenia [see Warnings and Precautions (5.8) ] The common adverse reactions are anaphylaxis, "red man syndrome", acute kidney injury, hearing loss, neutropenia. …

Do not use if

Vancomycin Injection is contraindicated in patients with known hypersensitivity to vancomycin. Hypersensitivity to vancomycin ( 4 )

Warnings

Infusion Reactions : Hypotension, including shock and cardiac arrest, wheezing, dyspnea, urticaria, muscular and chest pain and "red man syndrome" which manifests as pruritus and erythema that involves the face, neck and upper torso may occur with rapid intravenous administration. To reduce the risk of infusion reactions, administer Vancomycin Injection over a period of 60 minutes or greater and also prior to intravenous anesthetic agents. ( 2.1 , 5.2 ) Nephrotoxicity : Systemic vancomycin exposure may result in acute kidney injury (AKI) including acute renal failure, mainly due to interstitial nephritis or less commonly acute tubular necrosis. …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary This formulation of Vancomycin Injection is not recommended for use during the first or second trimester of pregnancy because it contains the excipients, PEG 400 and NADA, which caused fetal malformations in animal reproduction studies (see Data ) . Advise pregnant women of the potential risk to the fetus. …

Storage

16.2 Storage NDC number Packaging configuration 70594-041-02 Carton of six 500 mg/100 mL bags 70594-041-03 Carton of twelve 500 mg/100 mL bags 70594-056-02 Carton of six 750 mg/150 mL bags 70594-056-03 Carton of twelve 750 mg/150 mL bags 70594-042-02 …

General information only, not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Vancomycin Hydrochloride for Injection

Add the expiry date on your pack for a full Trust Score.

3 free checks left today Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Vancomycin Hydrochloride for Injection

What is in Vancomycin Hydrochloride for Injection?

Vancomycin Hydrochloride for Injection contains Vancomycin (Vancomycin Hydrochloride) (500 mg), as powder for injection, according to its NAFDAC registration record.

Is Vancomycin Hydrochloride for Injection registered with NAFDAC?

Yes. Vancomycin Hydrochloride for Injection is listed on the NAFDAC register under registration number C4-1494, and its registration is active as of 27 October 2026.

Has Vancomycin Hydrochloride for Injection been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Vancomycin Hydrochloride for Injection in our automatically synced alert list.

How can I check that my pack of Vancomycin Hydrochloride for Injection is genuine?

Run a free authenticity scan with the NAFDAC number C4-1494, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Vancomycin Hydrochloride for Injection used for?

Vancomycin Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of: Septicemia ( 1.1 ) Infective Endocarditis ( 1.2 ) Skin and Skin Structure Infections ( 1.3 ) Bone Infections ( 1.4 ) Lower Respiratory Tract Infections ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Injec (Summarised from the official U.S. FDA label for vancomycin (vancomycin hydrochloride). Always follow your doctor or pharmacist.)

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