Home NDC 68084-729 Galantamine
Product NDC 68084-729
11-digit product format 680840729
Labeler code 68084
Product ID 68084-729_2864c9b5-d581-daf1-e063-6394a90a2923
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Galantamine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler American Health Packaging
Application ANDA090957
Marketing category ANDA
Marketing start 2014-07-03
Substance GALANTAMINE HYDROBROMIDE
Active strength 4 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS 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.
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 RLD / RS 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.
Additional Listing Data#
Finished product Yes
Brand name base Galantamine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GALANTAMINE HYDROBROMIDE 4 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310436 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68084-729-11 Galantamine 1 in 1 BLISTER PACK TABLET, FILM COATED 1 8 68084-729-21 Galantamine 30 in 1 BOX, UNIT-DOSE TABLET, FILM COATED 30 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GALANTAMINE HYDROBROMIDE ACTIVE INGREDIENT MJ4PTD2VVW GALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 GALANTAMINE ACTIVE MOIETY 0D3Q044KCA GALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT GALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 GALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 GALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 GALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ GALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U GALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68084-729 GALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 8 Current NDC, Legacy NDC, 2 package rows 20241208_e80ec152-3616-4a13-9266-715550a8c398.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68084-729-11 68084072911 1 in 1 BLISTER PACK Historical 68084-729-21 68084072921 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-729-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-729-11) 30 blister pack 2014-07-03 0000-00-00 No No Current