FDA.reportPublic FDA data

Zinc Sulfate

Product NDC
66794-255
11-digit product format
667940255
Labeler code
66794
Product ID
66794-255_2983a6f9-6e71-82b0-e063-6294a90ad007
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zinc Sulfate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Piramal Critical Care Inc.
Application
ANDA216249
Marketing category
ANDA
Marketing start
2023-11-30
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
Rxcui2369390

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
66794-255-02Zinc Sulfate10 mL in 1 VIALINJECTION, SOLUTION103
66794-255-42Zinc Sulfate25 in 1 CARTONINJECTION, SOLUTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66794-255-02ML - Milliliter66794-255442dc6e2-cac0-43d2-9845-61747e26491212024-01-04
66794-255-42ML - Milliliter66794-255ff370bc8-0600-460e-87ca-6daa21ee258f12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66794-255ZINC SULFATE INJECTION, SOLUTION [PIRAMAL CRITICAL CARE INC.]3Current NDC, 2 package rows20241220_0b6078d9-624c-e162-e063-6394a90a147d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2369390zinc sulfate 1 MG in ML Injectable SolutionPSN0b6078d9-624c-e162-e063-6394a90a147d3
2369390zinc sulfate 1 MG/ML Injectable SolutionSCD0b6078d9-624c-e162-e063-6394a90a147d3
2369390ZnSO4 1 MG/ML Injectable SolutionSY0b6078d9-624c-e162-e063-6394a90a147d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66794-255-026679402550210 mL in 1 VIAL10 mlHistorical
66794-255-426679402554225 VIAL in 1 CARTON (66794-255-42) / 10 mL in 1 VIAL (66794-255-02) 25 vial2023-11-30NoNoHistorical