Home NDC 0615-7543 Galantamine
Product NDC 0615-7543
11-digit product format 006157543
Labeler code 0615
Product ID 0615-7543_a2a1a050-21be-46bd-954f-0a97017e9d38
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Galantamine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application ANDA077590
Marketing category ANDA
Marketing start 2009-05-29
Marketing end 0000-00-00
Substance GALANTAMINE HYDROBROMIDE
Active strength 12 mg/1
Pharmacologic classes Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0615-7543-39 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0615-7543-39 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0615-7543-39 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0615-7543-39 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-7543-39 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-7543-39 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-7543-39 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-7543-39 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-7543-39 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-7543-39 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-7543-39 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-7543-39 557ba5c1ecfa…9c80585c8c6e…
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 A077590-001 GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2009-05-29 A077590-002 GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2009-05-29 A077590-003 GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2009-05-29
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 A077590-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2009-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077590-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2009-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077590-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2009-05-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077590-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2009-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077590-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2009-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077590-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2009-05-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077590-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2009-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077590-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2009-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077590-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2009-05-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077590-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2009-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077590-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2009-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077590-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2009-05-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077590-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2009-05-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077590-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2009-05-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077590-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2009-05-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077590-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2009-05-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077590-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2009-05-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077590-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2009-05-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077590-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2009-05-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077590-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2009-05-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077590-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2009-05-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077590-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2009-05-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077590-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2009-05-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077590-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2009-05-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077590-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2009-05-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077590-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2009-05-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077590-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2009-05-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077590-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2009-05-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077590-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2009-05-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077590-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2009-05-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077590-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2009-05-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077590-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2009-05-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077590-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2009-05-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077590-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2009-05-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077590-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2009-05-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077590-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2009-05-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077590-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2009-05-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077590-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2009-05-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077590-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2009-05-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077590-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2009-05-29 8072bd15b7f6…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GALANTAMINE HYDROBROMIDE ACTIVE INGREDIENT MJ4PTD2VVW GALANTAMINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 GALANTAMINE ACTIVE MOIETY 0D3Q044KCA GALANTAMINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GALANTAMINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK GALANTAMINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO GALANTAMINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GALANTAMINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE GALANTAMINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A GALANTAMINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 GALANTAMINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J GALANTAMINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 GALANTAMINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GALANTAMINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 GALANTAMINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1