Galantamine

Product NDC: 65862-459
Requested package NDC: 65862-459-19
11-digit product format: 658620459
Labeler code: 65862
Product ID: 65862-459_a5420811-7ce9-4ea6-8d93-6422f016b0d8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Galantamine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA090957
Marketing category: ANDA
Marketing start: 2011-03-29
Substance: GALANTAMINE HYDROBROMIDE
Active strength: 8 mg/1
Pharmacologic classes: Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
unfinished package	package	65862-459	65862-459-19	UNFINISHED	Active or certified unfinished drug listing		2026-08-10

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 · 21 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 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`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
A090957-001	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29
A090957-002	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29
A090957-003	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090957-001	AB
A090957-002	AB
A090957-003	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	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`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	A090957-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090957-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090957-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090957-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090957-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090957-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090957-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090957-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090957-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090957-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090957-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090957-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090957-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090957-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090957-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090957-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090957-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090957-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090957-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090957-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090957-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090957-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090957-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090957-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090957-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090957-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090957-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090957-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090957-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090957-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090957-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090957-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090957-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090957-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090957-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090957-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090957-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090957-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090957-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090957-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GALANTAMINE HYDROBROMIDE	8 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310436	Internal RxNorm lookup
310437	Internal RxNorm lookup
579148	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
4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc	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	SPL version
65862-459-60	Galantamine	60 in 1 BOTTLE	TABLET, FILM COATED	60	14
65862-459-71	Galantamine	7000 in 1 BOTTLE	TABLET, FILM COATED	7000	14
65862-459-99	Galantamine	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-459-60	EA - Each	65862-459	f5dccb80-6c51-4a4b-adb7-a66a24a335d7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GALANTAMINE HYDROBROMIDE	ACTIVE INGREDIENT	MJ4PTD2VVW	GALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
GALANTAMINE	ACTIVE MOIETY	0D3Q044KCA	GALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	GALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	GALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-459	GALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14	Current NDC, Legacy NDC, 3 package rows	20240210_4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Galantamine	GALANTAMINE	Bryant Ranch Prepack	261889d3-41c8-4655-98f7-41317778e7a1	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090957 application number: ANDA090957
Galantamine	GALANTAMINE	Bryant Ranch Prepack	694ea1a5-153a-4145-9910-a0a1dc4ddbcc	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090957 application number: ANDA090957
Galantamine	GALANTAMINE	American Health Packaging	e80ec152-3616-4a13-9266-715550a8c398	2024-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090957 application number: ANDA090957
Galantamine	GALANTAMINE	Aurobindo Pharma Limited	4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc	2024-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090957 application number: ANDA090957 ndc (product): 65862-459
Galantamine	GALANTAMINE	Rising Pharma Holdings, Inc.	a0dc1a93-b7b8-4179-8ea7-ceecbe1ef243	2024-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090957 application number: ANDA090957

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310437	galantamine HBr 8 MG Oral Tablet	PSN	694ea1a5-153a-4145-9910-a0a1dc4ddbcc	100
310437	galantamine 8 MG Oral Tablet	SCD	694ea1a5-153a-4145-9910-a0a1dc4ddbcc	100
310437	galantamine 8 MG (as galantamine hydrobromide 10.253 MG) Oral Tablet	SY	694ea1a5-153a-4145-9910-a0a1dc4ddbcc	100
579148	galantamine HBr 12 MG Oral Tablet	PSN	4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc	14
310436	galantamine HBr 4 MG Oral Tablet	PSN	4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc	14
310437	galantamine HBr 8 MG Oral Tablet	PSN	4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc	14
579148	galantamine 12 MG Oral Tablet	SCD	4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc	14
310436	galantamine 4 MG Oral Tablet	SCD	4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc	14
310437	galantamine 8 MG Oral Tablet	SCD	4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc	14
579148	galantamine 12 MG (as galantamine hydrobromide 15.379 MG) Oral Tablet	SY	4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc	14
310436	galantamine 4 MG (as galantamine hydrobromide 5.126 MG) Oral Tablet	SY	4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc	14
310437	galantamine 8 MG (as galantamine hydrobromide 10.253 MG) Oral Tablet	SY	4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
65862-459-19	65862045919	10000 TABLET, FILM COATED in 1 BAG (65862-459-19)	29-MAR-11	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Galantamine	Bryant Ranch Prepack	2025-11-04	HUMAN PRESCRIPTION DRUG LABEL	100
Galantamine	Aurobindo Pharma Limited	2024-02-08	Human Prescription Drug Label	14