GALZIN

Product NDC: 57844-208
11-digit product format: 578440208
Labeler code: 57844
Product ID: 57844-208_78cdd870-2e9f-4ee5-b656-f665a71040a0
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: 2026-06-30
Substance: ZINC ACETATE
Active strength: 50 mg/1
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag: No
Current FDA listing: Yes

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		2026-08-17
excluded package	package	57844-208	57844-208-52	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 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…`
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…`

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	Current NDC, Legacy NDC, 1 package rows	20250315_a0c72bff-20f3-4241-b966-34a95178d1a3.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 ndc (product): 57844-208

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	2026-06-30	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