Home NDC 70069-691 Zinc sulfate
Product NDC 70069-691
11-digit product format 700690691
Labeler code 70069
Product ID 70069-691_e1880316-9556-4529-8ba1-8669113a993e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zinc sulfate
Dosage form SOLUTION
Route INTRAVENOUS
Labeler Somerset Therapeutics, LLC
Application ANDA216135
Marketing category ANDA
Marketing start 2024-07-18
Substance ZINC SULFATE
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 44 .
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 A216135-001 ZINC SULFATE ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 A216135-002 ZINC SULFATE ZINC SULFATE EQ 30MG BASE/10ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17
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 2026-10-15 13:18:30 2026-09 A216135-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A216135-002 ZINC SULFATE EQ 30MG BASE/10ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 c2088c7a36db…2026-09-14 22:38:34 2026-08 A216135-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216135-002 ZINC SULFATE EQ 30MG BASE/10ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216135-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216135-002 ZINC SULFATE EQ 30MG BASE/10ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216135-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216135-002 ZINC SULFATE EQ 30MG BASE/10ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216135-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216135-002 ZINC SULFATE EQ 30MG BASE/10ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216135-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216135-002 ZINC SULFATE EQ 30MG BASE/10ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216135-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216135-002 ZINC SULFATE EQ 30MG BASE/10ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216135-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216135-002 ZINC SULFATE EQ 30MG BASE/10ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216135-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216135-002 ZINC SULFATE EQ 30MG BASE/10ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216135-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216135-002 ZINC SULFATE EQ 30MG BASE/10ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216135-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216135-002 ZINC SULFATE EQ 30MG BASE/10ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216135-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216135-002 ZINC SULFATE EQ 30MG BASE/10ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216135-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216135-002 ZINC SULFATE EQ 30MG BASE/10ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216135-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216135-002 ZINC SULFATE EQ 30MG BASE/10ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216135-001 ZINC SULFATE EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216135-002 ZINC SULFATE EQ 30MG BASE/10ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-07-17 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC SULFATE 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 2201521 Internal RxNorm lookup 2201524 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 70069-691-01 Zinc sulfate 5 mL in 1 VIAL SOLUTION 5 3 70069-691-25 Zinc sulfate 25 in 1 CARTON SOLUTION 25 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70069-691 ZINC SULFATE SOLUTION [SOMERSET THERAPEUTICS, LLC] 3 Current NDC, 2 package rows 20240719_c9d45d0e-a165-4112-81f9-c0e455572ecf.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 70069-691-01 70069069101 5 mL in 1 VIAL 5 ml Historical 70069-691-25 70069069125 25 VIAL in 1 CARTON (70069-691-25) / 5 mL in 1 VIAL (70069-691-01) 25 vial 2024-07-18 No No Current