Zinc Sulfate

Product NDC: 65219-403
11-digit product format: 652190403
Labeler code: 65219
Product ID: 65219-403_af258d83-398d-4601-ab09-14c9fe383cc2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zinc Sulfate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA216145
Marketing category: ANDA
Marketing start: 2022-12-27
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#

Ingredient, Strength table
Ingredient	Strength
ZINC SULFATE	3 mg/mL

Field, Values table
Field	Values
Unii	89DS0H96TB
Rxcui	2201521, 2201524, 2369390

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65219-403-01	Zinc Sulfate	10 mL in 1 VIAL	INJECTION, SOLUTION	10		1
65219-403-03	Zinc Sulfate	25 in 1 TRAY	INJECTION, SOLUTION	25		1

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65219-403-01	ML - Milliliter	65219-403	c30fd612-a34e-415a-ac82-f1be9deda1f6	1	2023-02-06
65219-403-03	ML - Milliliter	65219-403	d0e7b5f2-9419-4324-9828-7f3fde9f6199	1	2023-02-06

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65219-403	ZINC SULFATE (ZINC SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]	1	Current NDC, Legacy NDC, 2 package rows	20230110_37d54dcd-b720-4168-bfb2-c8f381466aac.zip

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2369390	zinc sulfate 1 MG in ML Injectable Solution	PSN	37d54dcd-b720-4168-bfb2-c8f381466aac	1
2201521	zinc sulfate 3 MG/ML Injectable Solution	PSN	37d54dcd-b720-4168-bfb2-c8f381466aac	1
2201524	zinc sulfate 5 MG/ML Injectable Solution	PSN	37d54dcd-b720-4168-bfb2-c8f381466aac	1
2369390	zinc sulfate 1 MG/ML Injectable Solution	SCD	37d54dcd-b720-4168-bfb2-c8f381466aac	1
2201521	zinc sulfate 3 MG/ML Injectable Solution	SCD	37d54dcd-b720-4168-bfb2-c8f381466aac	1
2201524	zinc sulfate 5 MG/ML Injectable Solution	SCD	37d54dcd-b720-4168-bfb2-c8f381466aac	1
2369390	ZnSO4 1 MG/ML Injectable Solution	SY	37d54dcd-b720-4168-bfb2-c8f381466aac	1
2201521	ZnSO4 3 MG/ML Injectable Solution	SY	37d54dcd-b720-4168-bfb2-c8f381466aac	1
2201524	ZnSO4 5 MG/ML Injectable Solution	SY	37d54dcd-b720-4168-bfb2-c8f381466aac	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65219-403-01	65219040301	10 mL in 1 VIAL	10 ml					Historical
65219-403-03	65219040303	25 VIAL in 1 TRAY (65219-403-03) / 10 mL in 1 VIAL (65219-403-01)	25 vial	2022-12-27	0000-00-00	No	No	Current