GALZIN

Product NDC: 57844-208
11-digit product format: 578440208
Labeler code: 57844
Product ID: 57844-208_7ea0058d-9cfe-4d20-983b-fb271da04ef7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zinc Acetate
Dosage form: CAPSULE
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: NDA020458
Marketing category: NDA
Marketing start: 1997-03-03
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	57844-208		D	Discontinued by firm		2026-10-02
excluded package	package	57844-208	57844-208-52	D	Discontinued by firm		2026-10-02

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
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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020458-001	GALZIN	EQ 25MG ZINC	CAPSULE / ORAL	RLD	1997-01-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020458-002	GALZIN	EQ 50MG ZINC	CAPSULE / ORAL	RLD, RS	1997-01-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020458-001	GALZIN	EQ 25MG ZINC	CAPSULE / ORAL	RLD	1997-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020458-002	GALZIN	EQ 50MG ZINC	CAPSULE / ORAL	RLD, RS	1997-01-28	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57844-208-52	GALZIN	250 in 1 BOTTLE	CAPSULE	250		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57844-208-52	EA - Each	57844-208	a7ab37b6-4237-4670-899e-34858a68ab2c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZINC ACETATE	ACTIVE INGREDIENT	FM5526K07A	GALZIN (ZINC ACETATE) CAPSULE [GATE PHARMACEUTICALS]	2
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	GALZIN (ZINC ACETATE) CAPSULE [GATE PHARMACEUTICALS]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	GALZIN (ZINC ACETATE) CAPSULE [GATE PHARMACEUTICALS]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GALZIN (ZINC ACETATE) CAPSULE [GATE PHARMACEUTICALS]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GALZIN (ZINC ACETATE) CAPSULE [GATE PHARMACEUTICALS]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	GALZIN (ZINC ACETATE) CAPSULE [GATE PHARMACEUTICALS]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GALZIN (ZINC ACETATE) CAPSULE [GATE PHARMACEUTICALS]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	GALZIN (ZINC ACETATE) CAPSULE [GATE PHARMACEUTICALS]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	GALZIN (ZINC ACETATE) CAPSULE [GATE PHARMACEUTICALS]	2
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	GALZIN (ZINC ACETATE) CAPSULE [GATE PHARMACEUTICALS]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GALZIN (ZINC ACETATE) CAPSULE [GATE PHARMACEUTICALS]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	GALZIN (ZINC ACETATE) CAPSULE [GATE PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57844-208	GALZIN (ZINC ACETATE) CAPSULE [TEVA PHARMACEUTICALS USA, INC.]	17	Legacy NDC, 1 package rows	20250315_a0c72bff-20f3-4241-b966-34a95178d1a3.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FM5526K07A	ZINC ACETATE	5970-45-6	ZINC ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
213049	GALZIN 25 MG Oral Capsule	PSN	a0c72bff-20f3-4241-b966-34a95178d1a3	17
213050	GALZIN 50 MG Oral Capsule	PSN	a0c72bff-20f3-4241-b966-34a95178d1a3	17
199994	zinc acetate 25 MG Oral Capsule	PSN	a0c72bff-20f3-4241-b966-34a95178d1a3	17
199995	zinc acetate 50 MG Oral Capsule	PSN	a0c72bff-20f3-4241-b966-34a95178d1a3	17
213049	zinc acetate 25 MG Oral Capsule [Galzin]	SBD	a0c72bff-20f3-4241-b966-34a95178d1a3	17
213050	zinc acetate 50 MG Oral Capsule [Galzin]	SBD	a0c72bff-20f3-4241-b966-34a95178d1a3	17
199994	zinc acetate 25 MG Oral Capsule	SCD	a0c72bff-20f3-4241-b966-34a95178d1a3	17
199995	zinc acetate 50 MG Oral Capsule	SCD	a0c72bff-20f3-4241-b966-34a95178d1a3	17
213049	Galzin 25 MG Oral Capsule	SY	a0c72bff-20f3-4241-b966-34a95178d1a3	17
213050	Galzin 50 MG Oral Capsule	SY	a0c72bff-20f3-4241-b966-34a95178d1a3	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57844-208-52	57844020852	250 CAPSULE in 1 BOTTLE (57844-208-52)	250 capsule	1997-03-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GALZIN ® (Zinc Acetate) Capsules	Teva Pharmaceuticals USA, Inc.	2024-04-30	HUMAN PRESCRIPTION DRUG LABEL	17