Galantamine

Product NDC
57237-051
11-digit product format
572370051
Labeler code
57237
Product ID
57237-051_f59a93d6-9a01-40ad-a9ef-4eaacff23b79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Galantamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA090957
Marketing category
ANDA
Marketing start
2011-03-29
Substance
GALANTAMINE HYDROBROMIDE
Active strength
12 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090957-001GALANTAMINE HYDROBROMIDEGALANTAMINE HYDROBROMIDEEQ 4MG BASETABLET / ORALAB2011-03-29
A090957-002GALANTAMINE HYDROBROMIDEGALANTAMINE HYDROBROMIDEEQ 8MG BASETABLET / ORALAB2011-03-29
A090957-003GALANTAMINE HYDROBROMIDEGALANTAMINE HYDROBROMIDEEQ 12MG BASETABLET / ORALAB2011-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090957-001AB
A090957-002AB
A090957-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090957-001GALANTAMINE HYDROBROMIDEEQ 4MG BASETABLET / ORALAB2011-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090957-002GALANTAMINE HYDROBROMIDEEQ 8MG BASETABLET / ORALAB2011-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090957-003GALANTAMINE HYDROBROMIDEEQ 12MG BASETABLET / ORALAB2011-03-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090957-001GALANTAMINE HYDROBROMIDEEQ 4MG BASETABLET / ORALAB2011-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090957-002GALANTAMINE HYDROBROMIDEEQ 8MG BASETABLET / ORALAB2011-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090957-003GALANTAMINE HYDROBROMIDEEQ 12MG BASETABLET / ORALAB2011-03-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A090957-001GALANTAMINE HYDROBROMIDEEQ 4MG BASETABLET / ORALAB2011-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090957-002GALANTAMINE HYDROBROMIDEEQ 8MG BASETABLET / ORALAB2011-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090957-003GALANTAMINE HYDROBROMIDEEQ 12MG BASETABLET / ORALAB2011-03-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090957-001GALANTAMINE HYDROBROMIDEEQ 4MG BASETABLET / ORALAB2011-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090957-002GALANTAMINE HYDROBROMIDEEQ 8MG BASETABLET / ORALAB2011-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090957-003GALANTAMINE HYDROBROMIDEEQ 12MG BASETABLET / ORALAB2011-03-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090957-001GALANTAMINE HYDROBROMIDEEQ 4MG BASETABLET / ORALAB2011-03-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090957-002GALANTAMINE HYDROBROMIDEEQ 8MG BASETABLET / ORALAB2011-03-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090957-003GALANTAMINE HYDROBROMIDEEQ 12MG BASETABLET / ORALAB2011-03-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090957-001GALANTAMINE HYDROBROMIDEEQ 4MG BASETABLET / ORALAB2011-03-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090957-002GALANTAMINE HYDROBROMIDEEQ 8MG BASETABLET / ORALAB2011-03-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090957-003GALANTAMINE HYDROBROMIDEEQ 12MG BASETABLET / ORALAB2011-03-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090957-001GALANTAMINE HYDROBROMIDEEQ 4MG BASETABLET / ORALAB2011-03-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090957-002GALANTAMINE HYDROBROMIDEEQ 8MG BASETABLET / ORALAB2011-03-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090957-003GALANTAMINE HYDROBROMIDEEQ 12MG BASETABLET / ORALAB2011-03-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090957-001GALANTAMINE HYDROBROMIDEEQ 4MG BASETABLET / ORALAB2011-03-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090957-002GALANTAMINE HYDROBROMIDEEQ 8MG BASETABLET / ORALAB2011-03-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090957-003GALANTAMINE HYDROBROMIDEEQ 12MG BASETABLET / ORALAB2011-03-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090957-001GALANTAMINE HYDROBROMIDEEQ 4MG BASETABLET / ORALAB2011-03-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090957-002GALANTAMINE HYDROBROMIDEEQ 8MG BASETABLET / ORALAB2011-03-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090957-003GALANTAMINE HYDROBROMIDEEQ 12MG BASETABLET / ORALAB2011-03-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090957-001GALANTAMINE HYDROBROMIDEEQ 4MG BASETABLET / ORALAB2011-03-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A090957-002GALANTAMINE HYDROBROMIDEEQ 8MG BASETABLET / ORALAB2011-03-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A090957-003GALANTAMINE HYDROBROMIDEEQ 12MG BASETABLET / ORALAB2011-03-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090957-001GALANTAMINE HYDROBROMIDEEQ 4MG BASETABLET / ORALAB2011-03-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090957-002GALANTAMINE HYDROBROMIDEEQ 8MG BASETABLET / ORALAB2011-03-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090957-003GALANTAMINE HYDROBROMIDEEQ 12MG BASETABLET / ORALAB2011-03-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090957-001GALANTAMINE HYDROBROMIDEEQ 4MG BASETABLET / ORALAB2011-03-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090957-002GALANTAMINE HYDROBROMIDEEQ 8MG BASETABLET / ORALAB2011-03-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090957-003GALANTAMINE HYDROBROMIDEEQ 12MG BASETABLET / ORALAB2011-03-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090957-001GALANTAMINE HYDROBROMIDEEQ 4MG BASETABLET / ORALAB2011-03-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090957-002GALANTAMINE HYDROBROMIDEEQ 8MG BASETABLET / ORALAB2011-03-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090957-003GALANTAMINE HYDROBROMIDEEQ 12MG BASETABLET / ORALAB2011-03-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090957-001GALANTAMINE HYDROBROMIDEEQ 4MG BASETABLET / ORALAB2011-03-298072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090957-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090957-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090957-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090957-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090957-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090957-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090957-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090957-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090957-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090957-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090957-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090957-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090957-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090957-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090957-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090957-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090957-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090957-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090957-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090957-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090957-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090957-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090957-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090957-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090957-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090957-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090957-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090957-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090957-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090957-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090957-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090957-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090957-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090957-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090957-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090957-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090957-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090957-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090957-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090957-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GALANTAMINE HYDROBROMIDE12 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MJ4PTD2VVWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310436Internal RxNorm lookup
310437Internal RxNorm lookup
579148Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a0dc1a93-b7b8-4179-8ea7-ceecbe1ef243Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f780b87f-43f1-2d63-f0ea-2c214058238eProduct name220160831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-051-60Galantamine60 in 1 BOTTLETABLET, FILM COATED609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-051-60EA - Each57237-051b357677d-99ee-4c84-8222-54113e1ecd0f12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GALANTAMINE HYDROBROMIDEACTIVE INGREDIENTMJ4PTD2VVWGALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
GALANTAMINEACTIVE MOIETY0D3Q044KCAGALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4GALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UGALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-051GALANTAMINE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]9Current NDC, Legacy NDC, 1 package rows20240214_a0dc1a93-b7b8-4179-8ea7-ceecbe1ef243.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GalantamineGALANTAMINEBryant Ranch Prepack261889d3-41c8-4655-98f7-41317778e7a12026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090957
application number: ANDA090957
GalantamineGALANTAMINEBryant Ranch Prepack694ea1a5-153a-4145-9910-a0a1dc4ddbcc2025-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090957
application number: ANDA090957
GalantamineGALANTAMINEAmerican Health Packaginge80ec152-3616-4a13-9266-715550a8c3982024-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090957
application number: ANDA090957
GalantamineGALANTAMINEAurobindo Pharma Limited4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc2024-02-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090957
application number: ANDA090957
GalantamineGALANTAMINERising Pharma Holdings, Inc.a0dc1a93-b7b8-4179-8ea7-ceecbe1ef2432024-02-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090957
application number: ANDA090957
ndc (product): 57237-051

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
579148galantamine HBr 12 MG Oral TabletPSNa0dc1a93-b7b8-4179-8ea7-ceecbe1ef2439
310436galantamine HBr 4 MG Oral TabletPSNa0dc1a93-b7b8-4179-8ea7-ceecbe1ef2439
310437galantamine HBr 8 MG Oral TabletPSNa0dc1a93-b7b8-4179-8ea7-ceecbe1ef2439
579148galantamine 12 MG Oral TabletSCDa0dc1a93-b7b8-4179-8ea7-ceecbe1ef2439
310436galantamine 4 MG Oral TabletSCDa0dc1a93-b7b8-4179-8ea7-ceecbe1ef2439
310437galantamine 8 MG Oral TabletSCDa0dc1a93-b7b8-4179-8ea7-ceecbe1ef2439
579148galantamine 12 MG (as galantamine hydrobromide 15.379 MG) Oral TabletSYa0dc1a93-b7b8-4179-8ea7-ceecbe1ef2439
310436galantamine 4 MG (as galantamine hydrobromide 5.126 MG) Oral TabletSYa0dc1a93-b7b8-4179-8ea7-ceecbe1ef2439
310437galantamine 8 MG (as galantamine hydrobromide 10.253 MG) Oral TabletSYa0dc1a93-b7b8-4179-8ea7-ceecbe1ef2439

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-051-605723700516060 TABLET, FILM COATED in 1 BOTTLE (57237-051-60) 2011-03-290000-00-00NoNoCurrent