Zinc sulfate

Product NDC
70069-691
11-digit product format
700690691
Labeler code
70069
Product ID
70069-691_e1880316-9556-4529-8ba1-8669113a993e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zinc sulfate
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Somerset Therapeutics, LLC
Application
ANDA216135
Marketing category
ANDA
Marketing start
2024-07-18
Substance
ZINC SULFATE
Active strength
5 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 SULFATE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89DS0H96TB
Rxcui2201521, 2201524

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
70069-691-01Zinc sulfate5 mL in 1 VIALSOLUTION53
70069-691-25Zinc sulfate25 in 1 CARTONSOLUTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-691-01ML - Milliliter70069-6915ababcd1-f3dd-4cb2-a451-883d4a499cc612024-08-12
70069-691-25ML - Milliliter70069-69166a42f77-00e5-4f53-b23d-71c554f35e1812024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-691ZINC SULFATE SOLUTION [SOMERSET THERAPEUTICS, LLC]3Current NDC, 2 package rows20240719_c9d45d0e-a165-4112-81f9-c0e455572ecf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2201521zinc sulfate 3 MG/ML Injectable SolutionPSNc9d45d0e-a165-4112-81f9-c0e455572ecf3
2201524zinc sulfate 5 MG/ML Injectable SolutionPSNc9d45d0e-a165-4112-81f9-c0e455572ecf3
2201521zinc sulfate 3 MG/ML Injectable SolutionSCDc9d45d0e-a165-4112-81f9-c0e455572ecf3
2201524zinc sulfate 5 MG/ML Injectable SolutionSCDc9d45d0e-a165-4112-81f9-c0e455572ecf3
2201521ZnSO4 3 MG/ML Injectable SolutionSYc9d45d0e-a165-4112-81f9-c0e455572ecf3
2201524ZnSO4 5 MG/ML Injectable SolutionSYc9d45d0e-a165-4112-81f9-c0e455572ecf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70069-691-01700690691015 mL in 1 VIAL5 mlHistorical
70069-691-257006906912525 VIAL in 1 CARTON (70069-691-25) / 5 mL in 1 VIAL (70069-691-01) 25 vial2024-07-18NoNoCurrent