GALZIN

Product NDC
71863-125
11-digit product format
718630125
Labeler code
71863
Product ID
71863-125_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
50 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

Additional Listing Data#

Finished product
Yes
Brand name base
GALZIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC ACETATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFM5526K07A
Rxcui199994, 199995, 213049, 213050

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
71863-125-25GALZIN250 in 1 BOTTLECAPSULE, GELATIN COATED2505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71863-125-25EA - Each71863-12569edf43a-4e3b-4938-8087-73269230bf6c12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71863-125GALZIN (ZINC ACETATE) CAPSULE, GELATIN COATED [ETON PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20250304_2c4fb943-4b2f-273d-e063-6394a90abb47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213049GALZIN 25 MG Oral CapsulePSN2c4fb943-4b2f-273d-e063-6394a90abb475
213050GALZIN 50 MG Oral CapsulePSN2c4fb943-4b2f-273d-e063-6394a90abb475
199994zinc acetate 25 MG Oral CapsulePSN2c4fb943-4b2f-273d-e063-6394a90abb475
199995zinc acetate 50 MG Oral CapsulePSN2c4fb943-4b2f-273d-e063-6394a90abb475
213049zinc acetate 25 MG Oral Capsule [Galzin]SBD2c4fb943-4b2f-273d-e063-6394a90abb475
213050zinc acetate 50 MG Oral Capsule [Galzin]SBD2c4fb943-4b2f-273d-e063-6394a90abb475
199994zinc acetate 25 MG Oral CapsuleSCD2c4fb943-4b2f-273d-e063-6394a90abb475
199995zinc acetate 50 MG Oral CapsuleSCD2c4fb943-4b2f-273d-e063-6394a90abb475
213049Galzin 25 MG Oral CapsuleSY2c4fb943-4b2f-273d-e063-6394a90abb475
213050Galzin 50 MG Oral CapsuleSY2c4fb943-4b2f-273d-e063-6394a90abb475

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71863-125-2571863012525250 CAPSULE, GELATIN COATED in 1 BOTTLE (71863-125-25) 2025-03-03NoNoHistorical