Home NDC 60505-6261 Zinc Sulfate
Product NDC 60505-6261
11-digit product format 605056261
Labeler code 60505
Product ID 60505-6261_5896cfbb-5571-509f-40d9-da61c8263869
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zinc Sulfate Injection
Dosage form INJECTION
Route INTRAVENOUS
Labeler Apotex Corp
Application ANDA218059
Marketing category ANDA
Marketing start 2025-01-15
Substance ZINC SULFATE, UNSPECIFIED FORM
Active strength 1 mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 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 2026-09-14 22:38:34 2026-08 A218059-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-06-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218059-002 ZINC SULFATE EQ 10MG BASE/10ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-10-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218059-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-06-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218059-002 ZINC SULFATE EQ 10MG BASE/10ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-10-28 caaa826d4ba7…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# 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC SULFATE, UNSPECIFIED FORM 1 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-6261-0 Zinc Sulfate 10 mL in 1 VIAL INJECTION 10 2 60505-6261-5 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 60505-6261 ZINC SULFATE (ZINC SULFATE INJECTION) INJECTION [APOTEX CORP] 2 Current NDC, 2 package rows 20250117_b9cf2dab-6ec8-e099-464a-af46a3601971.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60505-6261-0 60505626100 10 mL in 1 VIAL 10 ml Historical 60505-6261-5 60505626105 25 VIAL in 1 CARTON (60505-6261-5) / 10 mL in 1 VIAL (60505-6261-0) 25 vial 2025-01-15 No No Current