Galantamine

Product NDC: 60505-2544
Requested package NDC: 60505-2544-6
11-digit product format: 605052544
Labeler code: 60505
Product ID: 60505-2544_8d445fef-2dbe-8ea0-7dcc-0a24914a598c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: galantamine hydrobromide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA077781
Marketing category: ANDA
Marketing start: 2012-11-05
Marketing end: 2021-09-30
Substance: GALANTAMINE HYDROBROMIDE
Active strength: 12 mg/1
Pharmacologic classes: Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60505-2544	60505-2544-6	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A077781-001	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	2011-09-27
A077781-002	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	2011-09-27
A077781-003	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	2011-09-27

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077781-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	2011-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077781-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	2011-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077781-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	2011-09-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077781-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	2011-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077781-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	2011-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077781-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	2011-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077781-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	2011-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077781-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	2011-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077781-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	2011-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077781-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	2011-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077781-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	2011-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077781-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	2011-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077781-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	2011-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077781-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	2011-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077781-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	2011-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077781-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	2011-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077781-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	2011-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077781-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	2011-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077781-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	2011-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077781-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	2011-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077781-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	2011-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077781-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	2011-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077781-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	2011-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077781-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	2011-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077781-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	2011-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077781-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	2011-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077781-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	2011-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077781-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	2011-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077781-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	2011-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077781-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	2011-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077781-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	2011-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077781-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	2011-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077781-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	2011-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077781-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	2011-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077781-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	2011-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077781-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	2011-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077781-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	2011-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077781-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	2011-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077781-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	2011-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077781-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	2011-09-27	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077781-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077781-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077781-003	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A077781-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077781-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077781-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077781-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077781-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077781-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077781-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077781-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077781-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077781-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077781-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077781-003	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-2544-6	EA - Each	60505-2544	aa649230-1677-4b74-8097-4b341592112d	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GALANTAMINE HYDROBROMIDE	ACTIVE INGREDIENT	MJ4PTD2VVW	GALANTAMINE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [APOTEX CORP.]	5
GALANTAMINE	ACTIVE MOIETY	0D3Q044KCA	GALANTAMINE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [APOTEX CORP.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GALANTAMINE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [APOTEX CORP.]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	GALANTAMINE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [APOTEX CORP.]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GALANTAMINE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [APOTEX CORP.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GALANTAMINE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [APOTEX CORP.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GALANTAMINE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [APOTEX CORP.]	5
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	GALANTAMINE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [APOTEX CORP.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GALANTAMINE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [APOTEX CORP.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GALANTAMINE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [APOTEX CORP.]	5

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-2544-6	60505254406	60 TABLET, FILM COATED in 1 BOTTLE (60505-2544-6)	2012-11-05	2021-09-30	No	No	Current