Galantamine Hydrobromide

Product NDC: 63629-2363
11-digit product format: 636292363
Labeler code: 63629
Product ID: 63629-2363_f97c7222-1f0d-4108-ad70-8148eea0fec2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Galantamine Hydrobromide
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA090178
Marketing category: ANDA
Marketing start: 2011-02-09
Substance: GALANTAMINE HYDROBROMIDE
Active strength: 24 mg/1
Pharmacologic classes: Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090178-001	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02
A090178-002	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02
A090178-003	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090178-001	AB
A090178-002	AB
A090178-003	AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090178-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090178-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090178-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090178-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090178-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090178-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090178-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090178-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090178-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090178-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090178-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090178-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090178-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090178-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090178-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090178-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090178-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090178-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090178-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090178-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090178-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090178-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090178-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090178-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090178-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090178-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090178-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090178-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090178-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090178-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090178-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090178-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090178-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090178-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090178-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090178-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090178-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090178-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090178-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090178-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-02-02	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090178-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090178-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090178-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090178-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090178-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090178-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090178-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090178-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090178-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090178-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090178-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090178-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090178-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090178-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090178-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090178-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090178-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090178-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090178-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090178-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090178-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090178-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090178-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090178-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090178-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090178-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090178-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090178-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090178-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090178-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090178-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090178-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090178-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090178-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090178-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090178-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090178-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090178-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090178-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090178-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Galantamine Hydrobromide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GALANTAMINE HYDROBROMIDE	24 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MJ4PTD2VVW	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
860707	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3e7e2839-a834-4464-a82a-7554e10ad004	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f780b87f-43f1-2d63-f0ea-2c214058238e	Product name	2	20160831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-2363-1	Galantamine Hydrobromide	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30		107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2363-1	EA - Each	63629-2363	cc2ffad1-3732-4052-9d94-6f1501e68e28	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2363	GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	107	Current NDC, Legacy NDC, 1 package rows	20240814_3e7e2839-a834-4464-a82a-7554e10ad004.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Galantamine Hydrobromide	GALANTAMINE HYDROBROMIDE	Bryant Ranch Prepack	0f74a146-f6ee-4910-82a3-177153526dd0	2025-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090178 application number: ANDA090178
Galantamine Hydrobromide	GALANTAMINE HYDROBROMIDE	Bryant Ranch Prepack	3059d10f-fb3d-4cbd-b936-104608889b67	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090178 application number: ANDA090178
Galantamine Hydrobromide	GALANTAMINE HYDROBROMIDE	Bryant Ranch Prepack	db5b6c1e-449b-413f-b0cc-ca2133aa4986	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090178 application number: ANDA090178
Galantamine Hydrobromide	GALANTAMINE HYDROBROMIDE	Bryant Ranch Prepack	3e7e2839-a834-4464-a82a-7554e10ad004	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090178 application number: ANDA090178 ndc (product): 63629-2363
Galantamine Hydrobromide	GALANTAMINE HYDROBROMIDE	Bryant Ranch Prepack	5cd99bc0-0f18-4800-a0f5-a94eebf0eead	2024-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090178 application number: ANDA090178
Galantamine Hydrobromide	GALANTAMINE HYDROBROMIDE	Bryant Ranch Prepack	c44108aa-bf20-4d45-b36f-d117320a675b	2024-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090178 application number: ANDA090178
Galantamine Hydrobromide	GALANTAMINE HYDROBROMIDE	Sun Pharmaceutical Industries, Inc.	d1697161-ebe8-42b0-83e7-c9de4412546c	2023-10-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090178 application number: ANDA090178

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MJ4PTD2VVW	GALANTAMINE HYDROBROMIDE	1953-04-4	GALANTAMINE HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
860707	galantamine HBr 24 MG 24HR Extended Release Oral Capsule	PSN	3e7e2839-a834-4464-a82a-7554e10ad004	107
860707	24 HR galantamine hydrobromide 24 MG Extended Release Oral Capsule	SCD	3e7e2839-a834-4464-a82a-7554e10ad004	107
860707	galantamine hydrobromide 24 MG 24 HR Extended Release Oral Capsule	SY	3e7e2839-a834-4464-a82a-7554e10ad004	107

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2363-1	63629236301	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-2363-1)	2011-02-09	0000-00-00	No	No	Current