GALANTAMINE TABLETS

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-30
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 8
Source: legacy-cache
Hydrated at: 2026-08-01 20:48:24

Label at a glance#

ProductGalantamine

Active ingredientGALANTAMINE HYDROBROMIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-755-14 in bottle of 60 tablets

Galantamine Tablets USP, 4 mg

R_xonly

60 tablets

NDC 65841-756-14 in bottle of 60 tablets

Galantamine Tablets USP, 8 mg

R_xonly

60 tablets

NDC 65841-757-14 in bottle of 60 tablets

Galantamine Tablets USP, 12 mg

R_xonly

60 tablets

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
GALANTAMINE HYDROBROMIDE	ACTIVE INGREDIENT	MJ4PTD2VVW	2
GALANTAMINE	ACTIVE MOIETY	0D3Q044KCA	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

Galantamine
GALANTAMINE HYDROBROMIDE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
PROPYLENE GLYCOL
SILICON DIOXIDE
TITANIUM DIOXIDE
FERRIC OXIDE RED
CROSPOVIDONE (15 MPA.S AT 5%)
FERRIC OXIDE YELLOW

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65841-755	65841-755-14, 65841-755-01, 65841-755-10, 65841-755-77
65841-756	65841-756-14, 65841-756-01, 65841-756-10, 65841-756-77
65841-757	65841-757-14, 65841-757-01, 65841-757-10, 65841-757-77

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GALANTAMINE HYDROBROMIDE	MJ4PTD2VVW	ACTIM
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
CROSPOVIDONE (15 MPA.S AT 5%)	68401960MK	IACT
GALANTAMINE HYDROBROMIDE	MJ4PTD2VVW	ACTIM
CROSPOVIDONE (15 MPA.S AT 5%)	68401960MK	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
GALANTAMINE HYDROBROMIDE	MJ4PTD2VVW	ACTIM
CROSPOVIDONE (15 MPA.S AT 5%)	68401960MK	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
HYPROMELLOSES	3NXW29V3WO	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 315 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 38 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	JELLY / TOPICAL	NA		Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, COATED PELLETS / ORAL	2 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE	1 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, CHEWABLE / ORAL		2 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	GRANULE, FOR SUSPENSION / ORAL	1.7 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, DELAYED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	WAFER / ORAL	66 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL / TOPICAL	19.2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS		214 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / INTRAVENOUS	50.33 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 27 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		520 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	PELLET / ORAL		640 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	LOTION / TOPICAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / VAGINAL	6.4 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SOLUTION / ORAL	1.8 mg/120ml		Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, COATED PELLETS / ORAL	3.32 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	9.5 %w/v		Exact identifier — unii candidate 38 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / SUBLINGUAL	1 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / TOPICAL		5148 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CREAM / VAGINAL		586 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	0.15 mg		Exact identifier — unii candidate 21 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078898-001	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-02-17
A078898-002	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-02-17
A078898-003	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-02-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078898-001	AB
A078898-002	AB
A078898-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A078898-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078898-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078898-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-02-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078898-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078898-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078898-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-02-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078898-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078898-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078898-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078898-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078898-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078898-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078898-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078898-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078898-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078898-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-02-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078898-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-02-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078898-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078898-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-02-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078898-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-02-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078898-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078898-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-02-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078898-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-02-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078898-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078898-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-02-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078898-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-02-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078898-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078898-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-02-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078898-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-02-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078898-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078898-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-02-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078898-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-02-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078898-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078898-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-02-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078898-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-02-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078898-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-02-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078898-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-02-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078898-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-02-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078898-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-02-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078898-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-02-17	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078898-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078898-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078898-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078898-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078898-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078898-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078898-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078898-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078898-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078898-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078898-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078898-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078898-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078898-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078898-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078898-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078898-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078898-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078898-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078898-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078898-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078898-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078898-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078898-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078898-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078898-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078898-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078898-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078898-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078898-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078898-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078898-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078898-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078898-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078898-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078898-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078898-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078898-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078898-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078898-001	AB	1	`301d65b070ca…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
6cc1c1eb-9207-4c8c-be67-8df9b1d047b6			63bad97b-3df6-4e8f-b183-95f1e9801c8f	2025-04-18		Exact identifier spl set id: 63bad97b-3df6-4e8f-b183-95f1e9801c8f

Reported adverse events (FAERS/openFDA)#

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