FDA.reportPublic FDA data

zinc sulfate

Product NDC
70710-1877
11-digit product format
707101877
Labeler code
70710
Product ID
70710-1877_245bc553-262e-47ff-91d0-0b7c136b6413
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zinc sulfate injection,
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA217074
Marketing category
ANDA
Marketing start
2023-12-07
Substance
ZINC SULFATE
Active strength
3 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 SULFATE3 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
70710-1877-1zinc sulfate10 mL in 1 VIALSOLUTION102
70710-1877-7zinc sulfate25 in 1 CARTONSOLUTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1877-1ML - Milliliter70710-18771a5bcba7-b533-4d00-8102-c772991c744312024-03-12
70710-1877-7ML - Milliliter70710-187765919938-a56b-4348-aca1-280dc08196dc12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1877ZINC SULFATE (ZINC SULFATE INJECTION,) SOLUTION [ZYDUS PHARMACEUTICALS USA INC.]2Current NDC, 2 package rows20241208_95aa8437-10bc-4205-939f-d21d8fa52a00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2369390zinc sulfate 1 MG in ML Injectable SolutionPSN95aa8437-10bc-4205-939f-d21d8fa52a002
2201521zinc sulfate 3 MG/ML Injectable SolutionPSN95aa8437-10bc-4205-939f-d21d8fa52a002
2201524zinc sulfate 5 MG/ML Injectable SolutionPSN95aa8437-10bc-4205-939f-d21d8fa52a002
2369390zinc sulfate 1 MG/ML Injectable SolutionSCD95aa8437-10bc-4205-939f-d21d8fa52a002
2201521zinc sulfate 3 MG/ML Injectable SolutionSCD95aa8437-10bc-4205-939f-d21d8fa52a002
2201524zinc sulfate 5 MG/ML Injectable SolutionSCD95aa8437-10bc-4205-939f-d21d8fa52a002
2369390ZnSO4 1 MG/ML Injectable SolutionSY95aa8437-10bc-4205-939f-d21d8fa52a002
2201521ZnSO4 3 MG/ML Injectable SolutionSY95aa8437-10bc-4205-939f-d21d8fa52a002
2201524ZnSO4 5 MG/ML Injectable SolutionSY95aa8437-10bc-4205-939f-d21d8fa52a002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-1877-17071018770110 mL in 1 VIAL10 mlHistorical
70710-1877-77071018770725 VIAL in 1 CARTON (70710-1877-7) / 10 mL in 1 VIAL (70710-1877-1) 25 vial2023-12-07NoNoHistorical