Zinc Sulfate

Product NDC
68083-608
11-digit product format
680830608
Labeler code
68083
Product ID
68083-608_cfa59996-1de2-4313-a7ac-1766764513e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zinc Sulfate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA216249
Marketing category
ANDA
Marketing start
2023-09-01
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
68083-608-25Zinc Sulfate10 mL in 1 VIALINJECTION, SOLUTION105
68083-608-25Zinc Sulfate25 in 1 CARTONINJECTION, SOLUTION255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-608ZINC SULFATE INJECTION, SOLUTION [GLAND PHARMA LIMITED]5Current NDC, 2 package rows20230921_8f354f0a-4e10-4e4e-b86c-49d97cbd631d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2369390zinc sulfate 1 MG in ML Injectable SolutionPSN8f354f0a-4e10-4e4e-b86c-49d97cbd631d5
2201521zinc sulfate 3 MG/ML Injectable SolutionPSN8f354f0a-4e10-4e4e-b86c-49d97cbd631d5
2201524zinc sulfate 5 MG/ML Injectable SolutionPSN8f354f0a-4e10-4e4e-b86c-49d97cbd631d5
2369390zinc sulfate 1 MG/ML Injectable SolutionSCD8f354f0a-4e10-4e4e-b86c-49d97cbd631d5
2201521zinc sulfate 3 MG/ML Injectable SolutionSCD8f354f0a-4e10-4e4e-b86c-49d97cbd631d5
2201524zinc sulfate 5 MG/ML Injectable SolutionSCD8f354f0a-4e10-4e4e-b86c-49d97cbd631d5
2369390ZnSO4 1 MG/ML Injectable SolutionSY8f354f0a-4e10-4e4e-b86c-49d97cbd631d5
2201521ZnSO4 3 MG/ML Injectable SolutionSY8f354f0a-4e10-4e4e-b86c-49d97cbd631d5
2201524ZnSO4 5 MG/ML Injectable SolutionSY8f354f0a-4e10-4e4e-b86c-49d97cbd631d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68083-608-256808306082525 VIAL in 1 CARTON (68083-608-25) / 10 mL in 1 VIAL25 vial2023-09-01NoNoCurrent