Home NDC 60505-2542 Galantamine
Product NDC 60505-2542
11-digit product format 605052542
Labeler code 60505
Product ID 60505-2542_8d445fef-2dbe-8ea0-7dcc-0a24914a598c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name galantamine hydrobromide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Apotex Corp.
Application ANDA077781
Marketing category ANDA
Marketing start 2012-11-05
Marketing end 2021-11-30
Substance GALANTAMINE HYDROBROMIDE
Active strength 4 mg/1
Pharmacologic classes Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A077781-001 GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2011-09-27 A077781-002 GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2011-09-27 A077781-003 GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2011-09-27
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 · 129 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 2026-09-14 22:38:34 2026-08 A077781-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2011-09-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077781-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2011-09-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077781-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2011-09-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077781-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2011-09-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077781-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2011-09-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077781-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2011-09-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077781-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2011-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077781-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2011-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077781-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2011-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077781-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2011-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077781-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2011-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077781-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2011-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077781-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2011-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077781-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2011-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077781-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2011-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077781-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2011-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077781-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2011-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077781-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2011-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077781-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2011-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077781-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2011-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077781-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2011-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077781-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2011-09-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077781-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2011-09-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077781-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2011-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077781-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2011-09-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077781-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2011-09-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077781-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2011-09-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077781-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2011-09-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077781-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2011-09-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077781-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2011-09-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077781-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2011-09-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077781-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2011-09-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077781-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2011-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077781-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2011-09-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077781-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2011-09-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077781-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2011-09-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077781-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2011-09-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077781-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL 2011-09-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077781-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL 2011-09-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077781-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL 2011-09-27 301d65b070ca…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GALANTAMINE HYDROBROMIDE ACTIVE INGREDIENT MJ4PTD2VVW GALANTAMINE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [APOTEX CORP.] 5 GALANTAMINE ACTIVE MOIETY 0D3Q044KCA GALANTAMINE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [APOTEX CORP.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GALANTAMINE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [APOTEX CORP.] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 GALANTAMINE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [APOTEX CORP.] 5 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 GALANTAMINE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [APOTEX CORP.] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO GALANTAMINE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [APOTEX CORP.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GALANTAMINE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [APOTEX CORP.] 5 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B GALANTAMINE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [APOTEX CORP.] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ GALANTAMINE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [APOTEX CORP.] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GALANTAMINE (GALANTAMINE HYDROBROMIDE) TABLET, FILM COATED [APOTEX CORP.] 5
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60505-2542-6 60505254206 60 TABLET, FILM COATED in 1 BOTTLE (60505-2542-6) 2012-11-05 2021-11-30 No No Current