Home NDC 71863-124 GALZIN
Product NDC 71863-124
11-digit product format 718630124
Labeler code 71863
Product ID 71863-124_42c879cc-38e0-c9bc-e063-6294a90a204d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zinc Acetate
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Eton Pharmaceuticals, Inc.
Application NDA020458
Marketing category NDA
Marketing start 2025-03-03
Substance ZINC ACETATE
Active strength 25 mg/1
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 N020458-001 GALZIN ZINC ACETATE EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 N020458-002 GALZIN ZINC ACETATE EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28
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 · 82 observed 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 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020458-001 GALZIN EQ 25MG ZINC CAPSULE / ORAL RLD 1997-01-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020458-002 GALZIN EQ 50MG ZINC CAPSULE / ORAL RLD, RS 1997-01-28 782e0a99824c…
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71863-124-25 GALZIN 250 in 1 BOTTLE CAPSULE, GELATIN COATED 250 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71863-124 GALZIN (ZINC ACETATE) CAPSULE, GELATIN COATED [ETON PHARMACEUTICALS, INC.] 1 Current NDC, 1 package rows 20250304_2c4fb943-4b2f-273d-e063-6394a90abb47.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GALZIN ZINC ACETATE Teva Pharmaceuticals USA, Inc. a0c72bff-20f3-4241-b966-34a95178d1a3 2024-04-30 Warnings, Adverse reactions Exact identifier application applno (NDA): 020458 application number: NDA020458
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71863-124-25 71863012425 250 CAPSULE, GELATIN COATED in 1 BOTTLE (71863-124-25) 2025-03-03 No No Historical