ZINC SULFATE INJECTION for intravenous use

Manufacturer
Zydus Lifesciences Limited
Effective date
2023-08-31
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:56:03

Label at a glance#

Productzinc sulfate
Active ingredientZINC SULFATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1848-1

Zinc Sulfate Injection, USP

10 mg/10 mL (1 mg/mL) of zinc

For intravenous use after dilution and admixing

PHARMACY BULK PACKAGE-Not for Direct Infusion

STERILE

10 mL

Rx only

vial label
vial label

NDC 70771-1848-7

Zinc Sulfate Injection, USP

10 mg/10 mL (1 mg/mL) of zinc

For intravenous use after dilution and admixing

PHARMACY BULK PACKAGE-Not for Direct Infusion

25 x 10 mL Vials

STERILE

10 mL

Rx only

carton label
carton label

NDC 70771-1849-1

Zinc Sulfate Injection, USP

30 mg/10 mL (3 mg/mL) of zinc

For intravenous use after dilution and admixing

PHARMACY BULK PACKAGE-Not for Direct Infusion

STERILE

10 mL

Rx only

vial label
vial label

NDC 70771-1849-7

Zinc Sulfate Injection, USP

30 mg/10 mL (3 mg/mL) of zinc

For intravenous use after dilution and admixing

PHARMACY BULK PACKAGE-Not for Direct Infusion

25 X 10 mL Vials

STERILE

10 mL

Rx only

carton label
carton label

NDC 70771-1850-1

Zinc Sulfate Injection, USP

25 mg/5 mL (5 mg/mL) of zinc

For intravenous use after dilution and admixing

PHARMACY BULK PACKAGE-Not for Direct Infusion

STERILE

5 mL

Rx only

vial label
vial label

NDC 70771-1850-7

Zinc Sulfate Injection, USP

25 mg/5 mL (5 mg/mL) of zinc

For intravenous use after dilution and admixing

PHARMACY BULK PACKAGE-Not for Direct Infusion

25 X 5 mL Vials

STERILE

5 mL

Rx only

carton label
carton label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2369390zinc sulfate 1 MG in ML Injectable SolutionPSN1
2201521zinc sulfate 3 MG/ML Injectable SolutionPSN1
2201524zinc sulfate 5 MG/ML Injectable SolutionPSN1
2369390zinc sulfate 1 MG/ML Injectable SolutionSCD1
2201521zinc sulfate 3 MG/ML Injectable SolutionSCD1
2201524zinc sulfate 5 MG/ML Injectable SolutionSCD1
2369390ZnSO4 1 MG/ML Injectable SolutionSY1
2201521ZnSO4 3 MG/ML Injectable SolutionSY1
2201524ZnSO4 5 MG/ML Injectable SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
70771-1848-1zinc sulfate10 mL in 1 VIALINJECTION, SOLUTION101
70771-1848-7zinc sulfate25 in 1 CARTONINJECTION, SOLUTION251
70771-1849-1zinc sulfate10 mL in 1 VIALINJECTION, SOLUTION101
70771-1849-7zinc sulfate25 in 1 CARTONINJECTION, SOLUTION251
70771-1850-1zinc sulfate5 mL in 1 VIALINJECTION, SOLUTION51
70771-1850-7zinc sulfate25 in 1 CARTONINJECTION, SOLUTION251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1848ZINC SULFATE INJECTION, SOLUTION [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 2 package rows20231207_74d8d07b-cfd9-4262-b689-fea12673bbd1.zip
70771-1849ZINC SULFATE INJECTION, SOLUTION [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 2 package rows20231207_74d8d07b-cfd9-4262-b689-fea12673bbd1.zip
70771-1850ZINC SULFATE INJECTION, SOLUTION [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 2 package rows20231207_74d8d07b-cfd9-4262-b689-fea12673bbd1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217074-001ZINC SULFATEZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-22
A217074-002ZINC SULFATEZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-22
A217074-003ZINC SULFATEZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217074-001AP
A217074-002AP
A217074-003AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217074-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-2284e616aacf4f…
2026-09-14 22:38:342026-08A217074-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-2284e616aacf4f…
2026-09-14 22:38:342026-08A217074-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-2284e616aacf4f…
2026-08-18 06:07:402026-07A217074-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07A217074-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07A217074-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217074-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217074-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217074-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217074-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217074-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217074-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A217074-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217074-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217074-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217074-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217074-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217074-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217074-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217074-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217074-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217074-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217074-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217074-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217074-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217074-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217074-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217074-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217074-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217074-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217074-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217074-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217074-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217074-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A217074-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A217074-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217074-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217074-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217074-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217074-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-08-22301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A217074-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A217074-002AP184e616aacf4f…
2026-09-14 22:38:342026-08A217074-003AP184e616aacf4f…
2026-08-18 06:07:402026-07A217074-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A217074-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A217074-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217074-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217074-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217074-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217074-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217074-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217074-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217074-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217074-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217074-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217074-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217074-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217074-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217074-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217074-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217074-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217074-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217074-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217074-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217074-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217074-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217074-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217074-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217074-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217074-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217074-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217074-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217074-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217074-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217074-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217074-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217074-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217074-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217074-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217074-001AP1301d65b070ca…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
zinc sulfateZINC SULFATEZydus Lifesciences Limited74d8d07b-cfd9-4262-b689-fea12673bbd12023-08-31Exact identifier
ndc (package): 70771-1848-1
ndc (package): 70771-1848-7
ndc (package): 70771-1850-7
ndc (package): 70771-1849-1
ndc (package): 70771-1850-1
ndc (package): 70771-1849-7
ndc (product): 70771-1850
ndc (product): 70771-1848
ndc (product): 70771-1849
ndc11 (package): 70771184807
ndc11 (package): 70771184907
ndc11 (package): 70771185007
ndc11 (package): 70771184901
ndc11 (package): 70771185001
ndc11 (package): 70771184801
spl id: 4a7d1f4a-5a38-48a6-9eae-0616d6c77ecd
spl set id: 74d8d07b-cfd9-4262-b689-fea12673bbd1

Reported adverse events (FAERS/openFDA)#

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