Home NDC 70436-004 Galantamine
Product NDC 70436-004
11-digit product format 704360004
Labeler code 70436
Product ID 70436-004_4685d03a-2fae-235e-e063-6394a90afd77
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name galantamine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Slate Run Pharmaceuticals, LLC
Application ANDA077604
Marketing category ANDA
Marketing start 2017-08-02
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 A077604-001 GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB RS 2009-02-06 A077604-002 GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2009-02-06 A077604-003 GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2009-02-06
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 A077604-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB RS 2009-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077604-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2009-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077604-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2009-02-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077604-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB RS 2009-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077604-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2009-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077604-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2009-02-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077604-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB RS 2009-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077604-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2009-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077604-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2009-02-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077604-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB RS 2009-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077604-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2009-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077604-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2009-02-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077604-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB RS 2009-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077604-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2009-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077604-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2009-02-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077604-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB RS 2009-02-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077604-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2009-02-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077604-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2009-02-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077604-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB RS 2009-02-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077604-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2009-02-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077604-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2009-02-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077604-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB RS 2009-02-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077604-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2009-02-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077604-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2009-02-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077604-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB RS 2009-02-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077604-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2009-02-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077604-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2009-02-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077604-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB RS 2009-02-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077604-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2009-02-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077604-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2009-02-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077604-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB RS 2009-02-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077604-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2009-02-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077604-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2009-02-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077604-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB RS 2009-02-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077604-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2009-02-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077604-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2009-02-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077604-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB RS 2009-02-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077604-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2009-02-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077604-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2009-02-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077604-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB RS 2009-02-06 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 2027-12-31 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310436 Internal RxNorm lookup 310437 Internal RxNorm lookup 579148 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 70436-004-06 Galantamine 60 in 1 BOTTLE TABLET, FILM COATED 60 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70436-004 GALANTAMINE TABLET, FILM COATED [SLATE RUN PHARMACEUTICALS, LLC] 12 Current NDC, Legacy NDC, 1 package rows 20241208_56f365e5-0a23-4f69-e054-00144ff8d46c.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 · 3 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70436-004-06 70436000406 60 TABLET, FILM COATED in 1 BOTTLE (70436-004-06) 2017-08-02 0000-00-00 No No Current