Zinc Sulfate

Product NDC
66794-255
11-digit product format
667940255
Labeler code
66794
Product ID
66794-255_2983a6f9-6e71-82b0-e063-6294a90ad007
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zinc Sulfate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Piramal Critical Care Inc.
Application
ANDA216249
Marketing category
ANDA
Marketing start
2023-11-30
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 42.

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
A216249-001ZINC SULFATEZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-03
A216249-002ZINC SULFATEZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-03
A216249-003ZINC SULFATEZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-09-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216249-001AP
A216249-002AP
A216249-003AP

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 3 · 81 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A216249-001ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-03caaa826d4ba7…
2026-08-18 06:07:402026-07A216249-002ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-03caaa826d4ba7…
2026-08-18 06:07:402026-07A216249-003ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-09-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216249-001ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216249-002ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216249-003ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-09-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216249-001ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216249-002ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216249-003ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-09-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216249-001ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216249-002ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216249-003ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-09-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216249-001ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216249-002ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216249-003ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-09-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216249-001ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216249-002ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216249-003ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-09-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216249-001ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216249-002ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216249-003ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-09-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216249-001ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216249-002ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216249-003ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-09-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216249-001ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216249-002ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216249-003ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-09-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216249-001ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216249-002ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216249-003ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-09-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216249-001ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A216249-002ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A216249-003ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-09-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216249-001ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216249-002ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216249-003ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-09-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216249-001ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216249-002ZINC SULFATEEQ 30MG BASE/10ML (EQ 3MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216249-003ZINC SULFATEEQ 10MG BASE/10ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2023-09-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216249-001ZINC SULFATEEQ 25MG BASE/5ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSAP2022-05-031e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A216249-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A216249-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A216249-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216249-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216249-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216249-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216249-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216249-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216249-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216249-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216249-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216249-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216249-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216249-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216249-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216249-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216249-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216249-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216249-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216249-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216249-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216249-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216249-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216249-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216249-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216249-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216249-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216249-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216249-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216249-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216249-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A216249-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A216249-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216249-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216249-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216249-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216249-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216249-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216249-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216249-001AP11e350fbaab3a…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2023-01-26 05:58 UTC2023-01A216249-001CGT2022-12-243bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A216249-002CGT2022-12-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A216249-001CGT2022-12-243a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A216249-002CGT2022-12-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A216249-001CGT2022-12-24f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A216249-002CGT2022-12-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A216249-001CGT2022-12-24e64feba35796…
2022-09-29 23:25 UTC2022-09A216249-002CGT2022-12-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A216249-001CGT2022-12-24cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A216249-002CGT2022-12-24cb3db0bc1861…

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
0b6078d9-624c-e162-e063-6394a90a147dAvailable 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
66794-255-02Zinc Sulfate10 mL in 1 VIALINJECTION, SOLUTION103
66794-255-42Zinc Sulfate25 in 1 CARTONINJECTION, SOLUTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66794-255-02ML - Milliliter66794-255442dc6e2-cac0-43d2-9845-61747e26491212024-01-04
66794-255-42ML - Milliliter66794-255ff370bc8-0600-460e-87ca-6daa21ee258f12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66794-255ZINC SULFATE INJECTION, SOLUTION [PIRAMAL CRITICAL CARE INC.]3Current NDC, 2 package rows20241220_0b6078d9-624c-e162-e063-6394a90a147d.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zinc SulfateZINC SULFATEPiramal Critical Care Inc.dfa8a859-c285-17a3-e053-2a95a90a93432025-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216249
application number: ANDA216249
Zinc SulfateZINC SULFATEPiramal Critical Care Inc.0b6078d9-624c-e162-e063-6394a90a147d2024-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216249
application number: ANDA216249
ndc (product): 66794-255
Zinc SulfateZINC SULFATEGland Pharma Limited8f354f0a-4e10-4e4e-b86c-49d97cbd631d2023-09-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216249
application number: ANDA216249

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2369390zinc sulfate 1 MG in ML Injectable SolutionPSN0b6078d9-624c-e162-e063-6394a90a147d3
2369390zinc sulfate 1 MG/ML Injectable SolutionSCD0b6078d9-624c-e162-e063-6394a90a147d3
2369390ZnSO4 1 MG/ML Injectable SolutionSY0b6078d9-624c-e162-e063-6394a90a147d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66794-255-026679402550210 mL in 1 VIAL10 mlHistorical
66794-255-426679402554225 VIAL in 1 CARTON (66794-255-42) / 10 mL in 1 VIAL (66794-255-02) 25 vial2023-11-30NoNoCurrent