Home NDC 65841-757 Galantamine
Product NDC 65841-757
11-digit product format 658410757
Labeler code 65841
Product ID 65841-757_6ef0e163-f218-4693-b490-a4e863220942
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Galantamine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA078898
Marketing category ANDA
Marketing start 2011-10-10
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 2023-12-31
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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 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.
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 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…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078898-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2011-02-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078898-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2011-02-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078898-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2011-02-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078898-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2011-02-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078898-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2011-02-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078898-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2011-02-17 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GALANTAMINE HYDROBROMIDE ACTIVE INGREDIENT MJ4PTD2VVW GALANTAMINE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 GALANTAMINE ACTIVE MOIETY 0D3Q044KCA GALANTAMINE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK GALANTAMINE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 GALANTAMINE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT GALANTAMINE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO GALANTAMINE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X GALANTAMINE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GALANTAMINE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 GALANTAMINE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 GALANTAMINE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GALANTAMINE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65841-757-01 65841075701 100 TABLET, FILM COATED in 1 BOTTLE (65841-757-01) 2011-10-10 0000-00-00 No No Current 65841-757-10 65841075710 1000 TABLET, FILM COATED in 1 BOTTLE (65841-757-10) 2011-10-10 0000-00-00 No No Current 65841-757-14 65841075714 60 TABLET, FILM COATED in 1 BOTTLE (65841-757-14) 2011-10-10 0000-00-00 No No Current 65841-757-77 65841075777 10 BLISTER PACK in 1 CARTON (65841-757-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2011-10-10 0000-00-00 No No Current