Zinc Sulfate

Product NDC
65219-401
11-digit product format
652190401
Labeler code
65219
Product ID
65219-401_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
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 1.

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
A216145-001ZINC SULFATEZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-27
A216145-002ZINC SULFATEZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-27
A216145-003ZINC SULFATEZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216145-001AP
A216145-002AP
A216145-003AP

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 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216145-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216145-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216145-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216145-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216145-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216145-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A216145-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216145-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216145-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216145-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216145-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216145-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216145-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216145-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216145-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216145-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216145-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216145-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216145-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216145-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216145-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216145-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216145-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216145-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216145-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216145-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216145-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216145-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A216145-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A216145-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216145-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216145-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216145-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216145-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216145-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216145-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216145-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216145-002ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216145-003ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216145-001ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-12-278072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216145-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216145-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216145-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216145-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216145-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216145-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216145-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216145-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216145-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216145-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216145-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216145-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216145-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216145-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216145-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216145-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216145-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216145-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216145-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216145-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216145-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216145-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216145-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216145-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216145-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216145-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216145-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216145-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A216145-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A216145-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216145-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216145-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216145-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216145-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216145-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216145-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216145-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216145-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216145-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216145-001AP18072bd15b7f6…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2023-12-20 04:57 UTC2023-12A216145-001CGT2023-08-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216145-001CGT2023-08-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216145-001CGT2023-08-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216145-001CGT2023-08-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216145-001CGT2023-08-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A216145-001CGT2023-08-14053a50430f4f…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC SULFATE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89DS0H96TBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
37d54dcd-b720-4168-bfb2-c8f381466aacAvailable on FDA.report

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
65219-401-00Zinc Sulfate10 mL in 1 VIALINJECTION, SOLUTION101
65219-401-01Zinc Sulfate25 in 1 TRAYINJECTION, SOLUTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-401-00ML - Milliliter65219-401b5f9f2cb-6a3e-4405-8e00-f75c26a2efb712023-02-06
65219-401-01ML - Milliliter65219-401d5e78941-e8dc-4e1e-916c-5cf5ddccc5c812023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-401ZINC SULFATE (ZINC SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]1Current NDC, Legacy NDC, 2 package rows20230110_37d54dcd-b720-4168-bfb2-c8f381466aac.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zinc SulfateZINC SULFATEFresenius Kabi USA, LLC37d54dcd-b720-4168-bfb2-c8f381466aac2023-01-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216145
application number: ANDA216145
ndc (product): 65219-401

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2369390zinc sulfate 1 MG in ML Injectable SolutionPSN37d54dcd-b720-4168-bfb2-c8f381466aac1
2201521zinc sulfate 3 MG/ML Injectable SolutionPSN37d54dcd-b720-4168-bfb2-c8f381466aac1
2201524zinc sulfate 5 MG/ML Injectable SolutionPSN37d54dcd-b720-4168-bfb2-c8f381466aac1
2369390zinc sulfate 1 MG/ML Injectable SolutionSCD37d54dcd-b720-4168-bfb2-c8f381466aac1
2201521zinc sulfate 3 MG/ML Injectable SolutionSCD37d54dcd-b720-4168-bfb2-c8f381466aac1
2201524zinc sulfate 5 MG/ML Injectable SolutionSCD37d54dcd-b720-4168-bfb2-c8f381466aac1
2369390ZnSO4 1 MG/ML Injectable SolutionSY37d54dcd-b720-4168-bfb2-c8f381466aac1
2201521ZnSO4 3 MG/ML Injectable SolutionSY37d54dcd-b720-4168-bfb2-c8f381466aac1
2201524ZnSO4 5 MG/ML Injectable SolutionSY37d54dcd-b720-4168-bfb2-c8f381466aac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65219-401-006521904010010 mL in 1 VIAL10 mlHistorical
65219-401-016521904010125 VIAL in 1 TRAY (65219-401-01) / 10 mL in 1 VIAL (65219-401-00) 25 vial2022-12-270000-00-00NoNoCurrent