Home NDC 60505-6260 Zinc Sulfate
Product NDC 60505-6260
11-digit product format 605056260
Labeler code 60505
Product ID 60505-6260_c78f555b-3f22-d031-b241-769f29b4c936
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zinc Sulfate Injection
Dosage form INJECTION
Route INTRAVENOUS
Labeler Apotex Corp
Application ANDA218059
Marketing category ANDA
Marketing start 2024-08-01
Substance ZINC SULFATE, UNSPECIFIED FORM
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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218059-001 ZINC SULFATE ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-06-10 A218059-002 ZINC SULFATE ZINC SULFATE EQ 10MG BASE/10ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-10-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
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 2026-02-19 14:30 UTC 2026-02 A218059-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218059-002 ZINC SULFATE EQ 10MG BASE/10ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218059-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218059-002 ZINC SULFATE EQ 10MG BASE/10ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218059-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218059-002 ZINC SULFATE EQ 10MG BASE/10ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218059-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218059-002 ZINC SULFATE EQ 10MG BASE/10ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218059-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218059-002 ZINC SULFATE EQ 10MG BASE/10ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218059-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218059-002 ZINC SULFATE EQ 10MG BASE/10ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218059-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218059-002 ZINC SULFATE EQ 10MG BASE/10ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-10-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218059-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218059-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-06-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218059-002 ZINC SULFATE EQ 10MG BASE/10ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-10-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218059-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-06-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218059-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-06-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218059-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-06-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218059-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-06-10 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218059-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218059-002 ZINC SULFATE EQ 10MG BASE/10ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-10-28 a50c72e98297…
Observed Orange Book normalized TE history# 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, UNSPECIFIED FORM 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2201524 Internal RxNorm lookup 2369390 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-6260-0 Zinc Sulfate 5 mL in 1 VIAL INJECTION 5 2 60505-6260-5 Zinc Sulfate 25 in 1 CARTON INJECTION 25 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-6260 ZINC SULFATE (ZINC SULFATE INJECTION) INJECTION [APOTEX CORP] 2 Current NDC, 2 package rows 20250117_b9cf2dab-6ec8-e099-464a-af46a3601971.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60505-6260-0 60505626000 5 mL in 1 VIAL 5 ml Historical 60505-6260-5 60505626005 25 VIAL in 1 CARTON (60505-6260-5) / 5 mL in 1 VIAL (60505-6260-0) 25 vial 2024-08-01 No No Current