zinc sulfate

Product NDC: 70710-1876
11-digit product format: 707101876
Labeler code: 70710
Product ID: 70710-1876_245bc553-262e-47ff-91d0-0b7c136b6413
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zinc sulfate injection,
Dosage form: SOLUTION
Route: INTRAVENOUS
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA217074
Marketing category: ANDA
Marketing start: 2023-12-07
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A217074-001	ZINC SULFATE	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22
A217074-002	ZINC SULFATE	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22
A217074-003	ZINC SULFATE	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217074-001	AP
A217074-002	AP
A217074-003	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 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A217074-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217074-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217074-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217074-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217074-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217074-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217074-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217074-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217074-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217074-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217074-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217074-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217074-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217074-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217074-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217074-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217074-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217074-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217074-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217074-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217074-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217074-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217074-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217074-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217074-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217074-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217074-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217074-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217074-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217074-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217074-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217074-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217074-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217074-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217074-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217074-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217074-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217074-002	ZINC SULFATE	EQ 25MG BASE/5ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217074-003	ZINC SULFATE	EQ 30MG BASE/10ML (EQ 3MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217074-001	ZINC SULFATE	EQ 10MG BASE/10ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-22	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217074-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217074-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217074-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217074-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217074-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217074-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217074-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217074-003	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217074-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217074-002	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217074-003	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217074-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217074-002	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217074-003	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217074-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217074-002	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217074-003	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217074-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217074-002	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217074-003	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217074-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217074-002	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217074-003	AP	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217074-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217074-002	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217074-003	AP	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	1 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
95aa8437-10bc-4205-939f-d21d8fa52a00	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
70710-1876-1	zinc sulfate	10 mL in 1 VIAL	SOLUTION	10		2
70710-1876-7	zinc sulfate	25 in 1 CARTON	SOLUTION	25		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70710-1876-1	ML - Milliliter	70710-1876	817c7d52-4699-43bd-a446-7890eec664e2	1	2024-03-12
70710-1876-7	ML - Milliliter	70710-1876	f31b4f85-bc1c-4aff-a35b-3405f50e4ca5	1	2024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70710-1876	ZINC SULFATE (ZINC SULFATE INJECTION,) SOLUTION [ZYDUS PHARMACEUTICALS USA INC.]	2	Current NDC, 2 package rows	20241208_95aa8437-10bc-4205-939f-d21d8fa52a00.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
zinc sulfate	ZINC SULFATE INJECTION,	Zydus Pharmaceuticals USA Inc.	95aa8437-10bc-4205-939f-d21d8fa52a00	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217074 application number: ANDA217074 ndc (product): 70710-1876
zinc sulfate	ZINC SULFATE	Zydus Lifesciences Limited	74d8d07b-cfd9-4262-b689-fea12673bbd1	2023-08-31		Exact identifier application applno (ANDA): 217074 application number: ANDA217074

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	95aa8437-10bc-4205-939f-d21d8fa52a00	2
2201521	zinc sulfate 3 MG/ML Injectable Solution	PSN	95aa8437-10bc-4205-939f-d21d8fa52a00	2
2201524	zinc sulfate 5 MG/ML Injectable Solution	PSN	95aa8437-10bc-4205-939f-d21d8fa52a00	2
2369390	zinc sulfate 1 MG/ML Injectable Solution	SCD	95aa8437-10bc-4205-939f-d21d8fa52a00	2
2201521	zinc sulfate 3 MG/ML Injectable Solution	SCD	95aa8437-10bc-4205-939f-d21d8fa52a00	2
2201524	zinc sulfate 5 MG/ML Injectable Solution	SCD	95aa8437-10bc-4205-939f-d21d8fa52a00	2
2369390	ZnSO4 1 MG/ML Injectable Solution	SY	95aa8437-10bc-4205-939f-d21d8fa52a00	2
2201521	ZnSO4 3 MG/ML Injectable Solution	SY	95aa8437-10bc-4205-939f-d21d8fa52a00	2
2201524	ZnSO4 5 MG/ML Injectable Solution	SY	95aa8437-10bc-4205-939f-d21d8fa52a00	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70710-1876-1	70710187601	10 mL in 1 VIAL	10 ml				Historical
70710-1876-7	70710187607	25 VIAL in 1 CARTON (70710-1876-7) / 10 mL in 1 VIAL (70710-1876-1)	25 vial	2023-12-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
zinc sulfate injection,	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2024-12-06	HUMAN PRESCRIPTION DRUG LABEL	2