Galantamine

Product NDC: 0591-3497
11-digit product format: 005913497
Labeler code: 0591
Product ID: 0591-3497_f5a193b9-78b1-4bfe-97b1-a98969f0f303
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Galantamine
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA079028
Marketing category: ANDA
Marketing start: 2008-12-15
Marketing end: 0000-00-00
Substance: GALANTAMINE HYDROBROMIDE
Active strength: 16 mg/1
Pharmacologic classes: Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
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	0591-3497		D	Discontinued by firm		2026-08-07
excluded package	package	0591-3497	0591-3497-30	D	Discontinued by firm		2026-08-07

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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0591-3497-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0591-3497-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0591-3497-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0591-3497-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0591-3497-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0591-3497-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0591-3497-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0591-3497-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0591-3497-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0591-3497-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0591-3497-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0591-3497-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	0591-3497-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	0591-3497-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	0591-3497-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	0591-3497-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	0591-3497-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	0591-3497-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	0591-3497-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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
A079028-001	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15
A079028-002	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15
A079028-003	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079028-001	AB
A079028-002	AB
A079028-003	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	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`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	A079028-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079028-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079028-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079028-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079028-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079028-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079028-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079028-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079028-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079028-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079028-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079028-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079028-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079028-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079028-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079028-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079028-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079028-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079028-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079028-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079028-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079028-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079028-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079028-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079028-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079028-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079028-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079028-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079028-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079028-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079028-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079028-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079028-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079028-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079028-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079028-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079028-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079028-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079028-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079028-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-3497-30	EA - Each	0591-3497	75f0b3d1-024f-413e-ae5f-eb2edc681a12	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GALANTAMINE HYDROBROMIDE	ACTIVE INGREDIENT	MJ4PTD2VVW	GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	2
GALANTAMINE	ACTIVE MOIETY	0D3Q044KCA	GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [WATSON LABORATORIES, INC.]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MJ4PTD2VVW	GALANTAMINE HYDROBROMIDE	1953-04-4	GALANTAMINE HYDROBROMIDE
0D3Q044KCA	GALANTAMINE	357-70-0	Galantamine

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-3497-30	00591349730	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0591-3497-30)	2008-12-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Galantamine	Actavis Pharma, Inc.	2022-05-17	HUMAN PRESCRIPTION DRUG LABEL	12
Galantamine Hydrobromide Extended-release Capsules	Aphena Pharma Solutions - Tennessee, LLC	2016-06-13	HUMAN PRESCRIPTION DRUG LABEL	1