Galantamine

Product NDC
65862-745
11-digit product format
658620745
Labeler code
65862
Product ID
65862-745_5b352114-093a-450c-81d1-4914dac5e2e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Galantamine
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA204895
Marketing category
ANDA
Marketing start
2016-08-05
Substance
GALANTAMINE HYDROBROMIDE
Active strength
16 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
A204895-001GALANTAMINE HYDROBROMIDEGALANTAMINE HYDROBROMIDEEQ 8MG BASECAPSULE, EXTENDED RELEASE / ORALABRS2016-08-05
A204895-002GALANTAMINE HYDROBROMIDEGALANTAMINE HYDROBROMIDEEQ 16MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-05
A204895-003GALANTAMINE HYDROBROMIDEGALANTAMINE HYDROBROMIDEEQ 24MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204895-001AB
A204895-002AB
A204895-003AB

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 UTC2026-02A204895-001GALANTAMINE HYDROBROMIDEEQ 8MG BASECAPSULE, EXTENDED RELEASE / ORALABRS2016-08-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204895-002GALANTAMINE HYDROBROMIDEEQ 16MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204895-003GALANTAMINE HYDROBROMIDEEQ 24MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204895-001GALANTAMINE HYDROBROMIDEEQ 8MG BASECAPSULE, EXTENDED RELEASE / ORALABRS2016-08-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204895-002GALANTAMINE HYDROBROMIDEEQ 16MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204895-003GALANTAMINE HYDROBROMIDEEQ 24MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A204895-001GALANTAMINE HYDROBROMIDEEQ 8MG BASECAPSULE, EXTENDED RELEASE / ORALABRS2016-08-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204895-002GALANTAMINE HYDROBROMIDEEQ 16MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204895-003GALANTAMINE HYDROBROMIDEEQ 24MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204895-001GALANTAMINE HYDROBROMIDEEQ 8MG BASECAPSULE, EXTENDED RELEASE / ORALABRS2016-08-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204895-002GALANTAMINE HYDROBROMIDEEQ 16MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204895-003GALANTAMINE HYDROBROMIDEEQ 24MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204895-001GALANTAMINE HYDROBROMIDEEQ 8MG BASECAPSULE, EXTENDED RELEASE / ORALABRS2016-08-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204895-002GALANTAMINE HYDROBROMIDEEQ 16MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204895-003GALANTAMINE HYDROBROMIDEEQ 24MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204895-001GALANTAMINE HYDROBROMIDEEQ 8MG BASECAPSULE, EXTENDED RELEASE / ORALABRS2016-08-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204895-002GALANTAMINE HYDROBROMIDEEQ 16MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204895-003GALANTAMINE HYDROBROMIDEEQ 24MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204895-001GALANTAMINE HYDROBROMIDEEQ 8MG BASECAPSULE, EXTENDED RELEASE / ORALABRS2016-08-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204895-002GALANTAMINE HYDROBROMIDEEQ 16MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204895-003GALANTAMINE HYDROBROMIDEEQ 24MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204895-001GALANTAMINE HYDROBROMIDEEQ 8MG BASECAPSULE, EXTENDED RELEASE / ORALABRS2016-08-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204895-002GALANTAMINE HYDROBROMIDEEQ 16MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204895-003GALANTAMINE HYDROBROMIDEEQ 24MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204895-001GALANTAMINE HYDROBROMIDEEQ 8MG BASECAPSULE, EXTENDED RELEASE / ORALABRS2016-08-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204895-002GALANTAMINE HYDROBROMIDEEQ 16MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204895-003GALANTAMINE HYDROBROMIDEEQ 24MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204895-001GALANTAMINE HYDROBROMIDEEQ 8MG BASECAPSULE, EXTENDED RELEASE / ORALABRS2016-08-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A204895-002GALANTAMINE HYDROBROMIDEEQ 16MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A204895-003GALANTAMINE HYDROBROMIDEEQ 24MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204895-001GALANTAMINE HYDROBROMIDEEQ 8MG BASECAPSULE, EXTENDED RELEASE / ORALABRS2016-08-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204895-002GALANTAMINE HYDROBROMIDEEQ 16MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204895-003GALANTAMINE HYDROBROMIDEEQ 24MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204895-001GALANTAMINE HYDROBROMIDEEQ 8MG BASECAPSULE, EXTENDED RELEASE / ORALABRS2016-08-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204895-002GALANTAMINE HYDROBROMIDEEQ 16MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204895-003GALANTAMINE HYDROBROMIDEEQ 24MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204895-001GALANTAMINE HYDROBROMIDEEQ 8MG BASECAPSULE, EXTENDED RELEASE / ORALABRS2016-08-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204895-002GALANTAMINE HYDROBROMIDEEQ 16MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204895-003GALANTAMINE HYDROBROMIDEEQ 24MG BASECAPSULE, EXTENDED RELEASE / ORALAB2016-08-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204895-001GALANTAMINE HYDROBROMIDEEQ 8MG BASECAPSULE, EXTENDED RELEASE / ORALABRS2016-08-058072bd15b7f6…

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 UTC2026-02A204895-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204895-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204895-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204895-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204895-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204895-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204895-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204895-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204895-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204895-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204895-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204895-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204895-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204895-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204895-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204895-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204895-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204895-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204895-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204895-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204895-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204895-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204895-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204895-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204895-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204895-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204895-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204895-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204895-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204895-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204895-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204895-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204895-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204895-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204895-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204895-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204895-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204895-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204895-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204895-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GALANTAMINE HYDROBROMIDE16 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
860695Internal RxNorm lookup
860707Internal RxNorm lookup
860715Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d0b75970-8d3d-408b-9e17-9cbad0f776b1Available 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
65862-745-01Galantamine100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10011
65862-745-05Galantamine500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50011
65862-745-30Galantamine30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3011
65862-745-90Galantamine90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9011
65862-745-99Galantamine1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-745-30EA - Each65862-7455497a37d-3333-45dd-8189-d27cfba9300012017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-745GALANTAMINE CAPSULE, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]11Current NDC, Legacy NDC, 5 package rows20240201_d0b75970-8d3d-408b-9e17-9cbad0f776b1.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GalantamineGALANTAMINEAurobindo Pharma Limitedd0b75970-8d3d-408b-9e17-9cbad0f776b12024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204895
application number: ANDA204895
ndc (product): 65862-745

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860695galantamine HBr 16 MG 24HR Extended Release Oral CapsulePSNd0b75970-8d3d-408b-9e17-9cbad0f776b111
860707galantamine HBr 24 MG 24HR Extended Release Oral CapsulePSNd0b75970-8d3d-408b-9e17-9cbad0f776b111
860715galantamine HBr 8 MG 24HR Extended Release Oral CapsulePSNd0b75970-8d3d-408b-9e17-9cbad0f776b111
86069524 HR galantamine hydrobromide 16 MG Extended Release Oral CapsuleSCDd0b75970-8d3d-408b-9e17-9cbad0f776b111
86070724 HR galantamine hydrobromide 24 MG Extended Release Oral CapsuleSCDd0b75970-8d3d-408b-9e17-9cbad0f776b111
86071524 HR galantamine hydrobromide 8 MG Extended Release Oral CapsuleSCDd0b75970-8d3d-408b-9e17-9cbad0f776b111
860695galantamine hydrobromide 16 MG 24 HR Extended Release Oral CapsuleSYd0b75970-8d3d-408b-9e17-9cbad0f776b111
860707galantamine hydrobromide 24 MG 24 HR Extended Release Oral CapsuleSYd0b75970-8d3d-408b-9e17-9cbad0f776b111
860715galantamine hydrobromide 8 MG 24 HR Extended Release Oral CapsuleSYd0b75970-8d3d-408b-9e17-9cbad0f776b111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-745-0165862074501100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-745-01) 2016-08-050000-00-00NoNoCurrent
65862-745-0565862074505500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-745-05) 2016-08-050000-00-00NoNoCurrent
65862-745-306586207453030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-745-30) 2016-08-050000-00-00NoNoCurrent
65862-745-906586207459090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-745-90) 2016-08-050000-00-00NoNoCurrent
65862-745-99658620745991000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-745-99) 2016-08-050000-00-00NoNoCurrent