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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209377-001	ZINC SULFATE	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18
N209377-002	ZINC SULFATE	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18
N209377-003	ZINC SULFATE	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N209377-001	AP
N209377-002	AP
N209377-003	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209377-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209377-003	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209377-001	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-07-18	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 85 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N209377-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209377-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209377-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209377-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209377-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209377-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209377-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209377-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209377-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209377-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209377-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209377-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209377-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209377-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209377-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209377-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209377-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209377-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209377-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209377-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209377-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209377-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209377-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209377-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209377-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209377-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209377-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209377-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209377-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209377-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209377-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209377-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209377-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209377-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209377-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209377-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209377-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209377-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209377-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209377-001	AP	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Zinc Sulfate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC SULFATE	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
89DS0H96TB	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2201521	Internal RxNorm lookup
2201524	Internal RxNorm lookup
2369390	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4b528c88-07a0-4dce-84c6-ccd32555bbff	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

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

DailyMed Billing Units#

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

DailyMed Dashboard NDC Coverage#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zinc Sulfate	ZINC SULFATE	American Regent, Inc.	4b528c88-07a0-4dce-84c6-ccd32555bbff	2020-10-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209377 application number: NDA209377 ndc (product): 0517-8005

DailyMed RxNorm Mappings#

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

Packages#

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