Zinc Sulfate

Product NDC
0517-6101
11-digit product format
005176101
Labeler code
0517
Product ID
0517-6101_daf09709-3280-43f1-9db6-e5dbad4c060b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zinc Sulfate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
American Regent, Inc.
Application
NDA209377
Marketing category
NDA
Marketing start
2020-05-18
Substance
ZINC SULFATE
Active strength
1 mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zinc Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC SULFATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89DS0H96TB
Rxcui2201521, 2201524, 2369390

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-6101-01Zinc Sulfate10 mL in 1 VIALINJECTION, SOLUTION108
0517-6101-25Zinc Sulfate25 in 1 TRAYINJECTION, SOLUTION258

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-6101-01ML - Milliliter0517-6101bdac5824-82f5-4866-b038-cf184cc9c67912020-06-05
0517-6101-25ML - Milliliter0517-6101811d7db9-8070-48cc-b143-438e2785967c12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-6101ZINC SULFATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]8Current NDC, Legacy NDC, 2 package rows20240123_4b528c88-07a0-4dce-84c6-ccd32555bbff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2369390zinc sulfate 1 MG in ML Injectable SolutionPSN4b528c88-07a0-4dce-84c6-ccd32555bbff8
2201521zinc sulfate 3 MG/ML Injectable SolutionPSN4b528c88-07a0-4dce-84c6-ccd32555bbff8
2201524zinc sulfate 5 MG/ML Injectable SolutionPSN4b528c88-07a0-4dce-84c6-ccd32555bbff8
2369390zinc sulfate 1 MG/ML Injectable SolutionSCD4b528c88-07a0-4dce-84c6-ccd32555bbff8
2201521zinc sulfate 3 MG/ML Injectable SolutionSCD4b528c88-07a0-4dce-84c6-ccd32555bbff8
2201524zinc sulfate 5 MG/ML Injectable SolutionSCD4b528c88-07a0-4dce-84c6-ccd32555bbff8
2369390ZnSO4 1 MG/ML Injectable SolutionSY4b528c88-07a0-4dce-84c6-ccd32555bbff8
2201521ZnSO4 3 MG/ML Injectable SolutionSY4b528c88-07a0-4dce-84c6-ccd32555bbff8
2201524ZnSO4 5 MG/ML Injectable SolutionSY4b528c88-07a0-4dce-84c6-ccd32555bbff8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0517-6101-010051761010110 mL in 1 VIAL10 mlHistorical
0517-6101-250051761012525 VIAL in 1 TRAY (0517-6101-25) / 10 mL in 1 VIAL (0517-6101-01) 25 vial2020-05-180000-00-00NoNoCurrent