Galantamine Hydrobromide

Product NDC: 51990-112
11-digit product format: 519900112
Labeler code: 51990
Product ID: 51990-112_a602c1a5-0c9c-4489-bc71-5fd6e0b06cae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: galantamine hydrobromide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Yabao Pharmaceutical Co., Ltd. Beijing
Application: NDA021169
Marketing category: NDA
Marketing start: 2001-03-01
Marketing end: 0000-00-00
Substance: GALANTAMINE HYDROBROMIDE
Active strength: 8 mg/1
Pharmacologic classes: Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51990-112		I	Inactivated by FDA	2026-08-07
excluded package	package	51990-112	51990-112-02	I	Inactivated by FDA	2026-08-07
excluded package	package	51990-112	51990-112-03	I	Inactivated by FDA	2026-08-07
excluded package	package	51990-112	51990-112-04	I	Inactivated by FDA	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 2 · 88 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51990-112-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51990-112-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51990-112-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51990-112-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51990-112-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51990-112-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51990-112-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51990-112-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51990-112-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51990-112-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51990-112-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51990-112-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51990-112-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51990-112-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51990-112-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51990-112-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51990-112-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51990-112-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51990-112-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51990-112-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51990-112-04	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51990-112-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51990-112-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51990-112-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51990-112-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51990-112-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51990-112-04	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51990-112-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51990-112-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51990-112-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51990-112-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51990-112-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51990-112-04	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51990-112-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51990-112-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51990-112-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	51990-112-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	51990-112-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	51990-112-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	51990-112-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	51990-112-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	51990-112-04	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	51990-112-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	51990-112-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	51990-112-04	`1332a3947898…`	`d4bfe170f9cd…`

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	RLD / RS	Approval date
N021169-001	RAZADYNE	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28
N021169-002	RAZADYNE	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28
N021169-003	RAZADYNE	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021169-001	RAZADYNE	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021169-002	RAZADYNE	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021169-003	RAZADYNE	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021169-001	RAZADYNE	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021169-002	RAZADYNE	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021169-003	RAZADYNE	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021169-001	RAZADYNE	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021169-002	RAZADYNE	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021169-003	RAZADYNE	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021169-001	RAZADYNE	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021169-002	RAZADYNE	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021169-003	RAZADYNE	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021169-001	RAZADYNE	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021169-002	RAZADYNE	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021169-003	RAZADYNE	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021169-001	RAZADYNE	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021169-002	RAZADYNE	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021169-003	RAZADYNE	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021169-001	RAZADYNE	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021169-002	RAZADYNE	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021169-003	RAZADYNE	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021169-001	RAZADYNE	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021169-002	RAZADYNE	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021169-003	RAZADYNE	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021169-001	RAZADYNE	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021169-002	RAZADYNE	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021169-003	RAZADYNE	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021169-001	RAZADYNE	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021169-002	RAZADYNE	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021169-003	RAZADYNE	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021169-001	RAZADYNE	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021169-002	RAZADYNE	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021169-003	RAZADYNE	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021169-001	RAZADYNE	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021169-002	RAZADYNE	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021169-003	RAZADYNE	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021169-001	RAZADYNE	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021169-002	RAZADYNE	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021169-003	RAZADYNE	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021169-001	RAZADYNE	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-02-28	`8072bd15b7f6…`

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	N021169-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021169-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021169-003	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021169-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021169-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021169-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021169-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021169-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021169-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021169-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021169-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021169-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021169-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021169-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021169-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021169-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021169-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021169-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021169-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021169-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021169-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021169-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021169-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021169-003	AB	1	`ea99ee380514…`

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51990-112-02	2020-01-31	C162847	48780-1	9d75b9d0-1975-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use galantamine hydrobromide safely and effectively. See full prescribing information for Galantamine Hydrobromide Tablets, USP. Galantamine Hydrobromide Tablets, USP for oral use Initial U.S. Approval: 2001
51990-112-03	2020-01-31	C162847	48780-1	9d75b9d0-1975-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use galantamine hydrobromide safely and effectively. See full prescribing information for Galantamine Hydrobromide Tablets, USP. Galantamine Hydrobromide Tablets, USP for oral use Initial U.S. Approval: 2001
51990-112-04	2020-01-31	C162847	48780-1	9d75b9d0-1975-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use galantamine hydrobromide safely and effectively. See full prescribing information for Galantamine Hydrobromide Tablets, USP. Galantamine Hydrobromide Tablets, USP for oral use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51990-112-02	Galantamine Hydrobromide	100 in 1 BOTTLE	TABLET, FILM COATED	100	1
51990-112-03	Galantamine Hydrobromide	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	1
51990-112-04	Galantamine Hydrobromide	60 in 1 BOTTLE	TABLET, FILM COATED	60	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
galantamine hydrobromide	ACTIVE INGREDIENT	MJ4PTD2VVW	GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING]	1
galantamine	ACTIVE MOIETY	0D3Q044KCA	GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING]	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING]	1
HYDROXYPROPYL CELLULOSE (TYPE E)	INACTIVE INGREDIENT	66O7AQV0RT	GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51990-112	GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING]	1	Legacy NDC, 3 package rows	20150602_7dc963dd-84d6-45f3-857f-46a44fe9edc8.zip

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
579148	galantamine HBr 12 MG Oral Tablet	PSN	7dc963dd-84d6-45f3-857f-46a44fe9edc8	1
310436	galantamine HBr 4 MG Oral Tablet	PSN	7dc963dd-84d6-45f3-857f-46a44fe9edc8	1
310437	galantamine HBr 8 MG Oral Tablet	PSN	7dc963dd-84d6-45f3-857f-46a44fe9edc8	1
579148	galantamine 12 MG Oral Tablet	SCD	7dc963dd-84d6-45f3-857f-46a44fe9edc8	1
310436	galantamine 4 MG Oral Tablet	SCD	7dc963dd-84d6-45f3-857f-46a44fe9edc8	1
310437	galantamine 8 MG Oral Tablet	SCD	7dc963dd-84d6-45f3-857f-46a44fe9edc8	1
579148	galantamine 12 MG (as galantamine hydrobromide 15.379 MG) Oral Tablet	SY	7dc963dd-84d6-45f3-857f-46a44fe9edc8	1
310436	galantamine 4 MG (as galantamine hydrobromide 5.126 MG) Oral Tablet	SY	7dc963dd-84d6-45f3-857f-46a44fe9edc8	1
310437	galantamine 8 MG (as galantamine hydrobromide 10.253 MG) Oral Tablet	SY	7dc963dd-84d6-45f3-857f-46a44fe9edc8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
51990-112-02	51990011202	100 in 1 BOTTLE	Historical
51990-112-03	51990011203	1000 in 1 BOTTLE	Historical
51990-112-04	51990011204	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Galantamine Hydrobromide	Yabao Pharmaceutical Co., Ltd. Beijing	2015-05-15	HUMAN PRESCRIPTION DRUG LABEL	1