FDA.reportPublic FDA data

Zinc Sulfate

Product NDC
60505-6260
11-digit product format
605056260
Labeler code
60505
Product ID
60505-6260_c78f555b-3f22-d031-b241-769f29b4c936
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zinc Sulfate Injection
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Apotex Corp
Application
ANDA218059
Marketing category
ANDA
Marketing start
2024-08-01
Substance
ZINC SULFATE, UNSPECIFIED FORM
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 SULFATE, UNSPECIFIED FORM5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89DS0H96TB
Rxcui2201524, 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
60505-6260-0Zinc Sulfate5 mL in 1 VIALINJECTION52
60505-6260-5Zinc Sulfate25 in 1 CARTONINJECTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6260-0ML - Milliliter60505-6260210a81ad-1923-467a-9ad4-0a2e9d27aab012024-08-12
60505-6260-5ML - Milliliter60505-6260c3f4a830-b4d9-453d-88d7-d738cc89016512024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6260ZINC SULFATE (ZINC SULFATE INJECTION) INJECTION [APOTEX CORP]2Current NDC, 2 package rows20250117_b9cf2dab-6ec8-e099-464a-af46a3601971.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2369390zinc sulfate 1 MG in ML Injectable SolutionPSNb9cf2dab-6ec8-e099-464a-af46a36019712
2201524zinc sulfate 5 MG/ML Injectable SolutionPSNb9cf2dab-6ec8-e099-464a-af46a36019712
2369390zinc sulfate 1 MG/ML Injectable SolutionSCDb9cf2dab-6ec8-e099-464a-af46a36019712
2201524zinc sulfate 5 MG/ML Injectable SolutionSCDb9cf2dab-6ec8-e099-464a-af46a36019712
2369390ZnSO4 1 MG/ML Injectable SolutionSYb9cf2dab-6ec8-e099-464a-af46a36019712
2201524ZnSO4 5 MG/ML Injectable SolutionSYb9cf2dab-6ec8-e099-464a-af46a36019712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60505-6260-0605056260005 mL in 1 VIAL5 mlHistorical
60505-6260-56050562600525 VIAL in 1 CARTON (60505-6260-5) / 5 mL in 1 VIAL (60505-6260-0) 25 vial2024-08-01NoNoCurrent