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Zinc Sulfate

Zinc Sulfate Injection · Injection

Prescription ANDA TE AP
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Zinc Sulfate
Generic name
Zinc Sulfate Injection
Dosage form
Injection
Route
Intravenous
Marketing category
ANDA · ANDA
Labeler
Apotex Corp
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Zinc SULFATE, Unspecified Form 1 mg/mL 1314666 —
Zinc SULFATE, Unspecified Form 5 mg/mL 1314666 —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection
Route of administration
Intravenous
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Copper Absorption Inhibitor [EPC] EPC 4 members — no class page
Decreased Copper Ion Absorption [PE] PE 4 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
218059
Application type
ANDA · Abbreviated New Drug Application
Approval date
June 10, 2024
Sponsor
APOTEX
Products on application
2
Submissions recorded
2
Products approved under application 218059.
Product Trade name Form Strength Ingredient Status TE Flags
218059-001 ZINC SULFATE SOLUTION ZINC SULFATE Prescription AP
218059-002 ZINC SULFATE SOLUTION ZINC SULFATE Prescription AP

Therapeutic equivalence

Source: Orange Book
TE code
AP
Reference Listed Drug
No
Reference Standard
No

What this rating means: Therapeutically equivalent — bioequivalence demonstrated (parenteral aqueous solutions)

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 218059.
Type No. Action Status Date Review
Supplement 1 Manufacturing (CMC) Approved October 28, 2024 Unknown
Original application 1 Approved June 10, 2024 Standard

Adverse event reports

Source: openFDA FAERS
4
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: ZINC SULFATE, UNSPECIFIED FORM. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
60505-6260-5 60505-6260 Apotex Corp 25 VIAL in 1 CARTON (60505-6260-5) / 5 mL in 1 VIAL (60505-6260-0) August 1, 2024
60505-6261-5 60505-6261 Apotex Corp 25 VIAL in 1 CARTON (60505-6261-5) / 10 mL in 1 VIAL (60505-6261-0) January 15, 2025
60505-6260 60505-6260 Apotex Corp — August 1, 2024
60505-6261 60505-6261 Apotex Corp — January 15, 2025

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.