Zinc Sulfate

Product NDC: 0517-8005
11-digit product format: 005178005
Labeler code: 0517
Product ID: 0517-8005_daf09709-3280-43f1-9db6-e5dbad4c060b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zinc Sulfate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: American Regent, Inc.
Application: NDA209377
Marketing category: NDA
Marketing start: 2019-10-01
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#

Ingredient, Strength table
Ingredient	Strength
ZINC SULFATE	5 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
0517-8005-01	Zinc Sulfate	5 mL in 1 VIAL	INJECTION, SOLUTION	5		8
0517-8005-25	Zinc Sulfate	25 in 1 TRAY	INJECTION, SOLUTION	25		8

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0517-8005-01	ML - Milliliter	0517-8005	9c927035-0130-4ba9-9ecd-827db7ded80f	1	2020-02-13
0517-8005-25	ML - Milliliter	0517-8005	743a00e4-c7b2-4333-ba1e-fbf2c53cc192	1	2020-02-13

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0517-8005	ZINC SULFATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20240123_4b528c88-07a0-4dce-84c6-ccd32555bbff.zip

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2369390	zinc sulfate 1 MG in ML Injectable Solution	PSN	4b528c88-07a0-4dce-84c6-ccd32555bbff	8
2201521	zinc sulfate 3 MG/ML Injectable Solution	PSN	4b528c88-07a0-4dce-84c6-ccd32555bbff	8
2201524	zinc sulfate 5 MG/ML Injectable Solution	PSN	4b528c88-07a0-4dce-84c6-ccd32555bbff	8
2369390	zinc sulfate 1 MG/ML Injectable Solution	SCD	4b528c88-07a0-4dce-84c6-ccd32555bbff	8
2201521	zinc sulfate 3 MG/ML Injectable Solution	SCD	4b528c88-07a0-4dce-84c6-ccd32555bbff	8
2201524	zinc sulfate 5 MG/ML Injectable Solution	SCD	4b528c88-07a0-4dce-84c6-ccd32555bbff	8
2369390	ZnSO4 1 MG/ML Injectable Solution	SY	4b528c88-07a0-4dce-84c6-ccd32555bbff	8
2201521	ZnSO4 3 MG/ML Injectable Solution	SY	4b528c88-07a0-4dce-84c6-ccd32555bbff	8
2201524	ZnSO4 5 MG/ML Injectable Solution	SY	4b528c88-07a0-4dce-84c6-ccd32555bbff	8

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0517-8005-01	00517800501	5 mL in 1 VIAL	5 ml					Historical
0517-8005-25	00517800525	25 VIAL in 1 TRAY (0517-8005-25) / 5 mL in 1 VIAL (0517-8005-01)	25 vial	2019-10-01	0000-00-00	No	No	Current