RAZADYNE

Product NDC: 50458-398
11-digit product format: 504580398
Labeler code: 50458
Product ID: 50458-398_ab2b6dfa-8107-11eb-8513-17f1fb2ca371
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: galantamine hydrobromide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Janssen Pharmaceuticals, Inc.
Application: NDA021169
Marketing category: NDA
Marketing start: 2001-03-01
Marketing end: 2022-03-04
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50458-398		D	Discontinued by firm		2026-08-07
excluded package	package	50458-398	50458-398-60	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 · 24 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	50458-398-60	`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	50458-398-60	`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	50458-398-60	`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	50458-398-60	`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	50458-398-60	`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	50458-398-60	`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	50458-398-60	`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	50458-398-60	`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	50458-398-60	`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	50458-398-60	`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	50458-398-60	`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	50458-398-60	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50458-398-60	EA - Each	50458-398	2ff0a454-1f7d-4a0b-94ec-422682a640bd	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
galantamine hydrobromide	ACTIVE INGREDIENT	MJ4PTD2VVW	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
galantamine	ACTIVE MOIETY	0D3Q044KCA	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
crospovidone	INACTIVE INGREDIENT	68401960MK	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
diethyl phthalate	INACTIVE INGREDIENT	UF064M00AF	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
ethylcelluloses	INACTIVE INGREDIENT	7Z8S9VYZ4B	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
gelatin	INACTIVE INGREDIENT	2G86QN327L	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
saccharin sodium	INACTIVE INGREDIENT	SB8ZUX40TY	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
talc	INACTIVE INGREDIENT	7SEV7J4R1U	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
water	INACTIVE INGREDIENT	059QF0KO0R	RAZADYNE (GALANTAMINE HYDROBROMIDE) CAPSULE, EXTENDED RELEASE RAZADYNE (GALANTAMINE HYDROBROMIDE) SOLUTION RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]	14
galantamine hydrobromide	ACTIVE INGREDIENT	MJ4PTD2VVW	RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
galantamine	ACTIVE MOIETY	0D3Q044KCA	RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
talc	INACTIVE INGREDIENT	7SEV7J4R1U	RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	RAZADYNE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2

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	e62efb5a-d2cc-4e11-9e61-10e65ef3d897	2
602734	Razadyne 12 MG Oral Tablet	PSN	e62efb5a-d2cc-4e11-9e61-10e65ef3d897	2
602734	galantamine 12 MG Oral Tablet [Razadyne]	SBD	e62efb5a-d2cc-4e11-9e61-10e65ef3d897	2
579148	galantamine 12 MG Oral Tablet	SCD	e62efb5a-d2cc-4e11-9e61-10e65ef3d897	2
579148	galantamine 12 MG (as galantamine hydrobromide 15.379 MG) Oral Tablet	SY	e62efb5a-d2cc-4e11-9e61-10e65ef3d897	2
602734	Razadyne 12 MG (galantamine hydrobromide 15.379 MG) Oral Tablet	SY	e62efb5a-d2cc-4e11-9e61-10e65ef3d897	2
602734	Razadyne 12 MG Oral Tablet	SY	e62efb5a-d2cc-4e11-9e61-10e65ef3d897	2

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RAZADYNE	Janssen Pharmaceuticals, Inc. \| Janssen Ortho LLC \| Janssen Pharmaceutica NV \| Janssen Pharmaceuticals, Inc	2022-10-11	HUMAN PRESCRIPTION DRUG LABEL	25
RAZADYNE ® galantamine HBr TABLETS	Rebel Distributors Corp	2010-11-11	HUMAN PRESCRIPTION DRUG LABEL	2