Home NDC 0904-7107 Rivastigmine Tartrate
Product NDC 0904-7107
11-digit product format 009047107
Labeler code 0904
Product ID 0904-7107_65cfb382-8f01-4ee8-8235-8ce2f5d3beec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rivastigmine Tartrate
Dosage form CAPSULE
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA204572
Marketing category ANDA
Marketing start 2016-03-25
Substance RIVASTIGMINE TARTRATE
Active strength 1.5 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204572-001 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2016-03-25 A204572-002 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2016-03-25 A204572-003 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2016-03-25 A204572-004 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2016-03-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 164 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 A204572-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2016-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204572-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2016-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204572-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2016-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204572-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2016-03-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204572-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2016-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204572-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2016-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204572-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2016-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204572-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2016-03-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204572-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2016-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204572-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2016-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204572-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2016-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204572-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2016-03-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204572-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2016-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204572-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2016-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204572-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2016-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204572-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2016-03-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204572-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2016-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204572-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2016-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204572-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2016-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204572-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2016-03-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204572-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2016-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204572-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2016-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204572-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2016-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204572-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2016-03-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204572-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2016-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204572-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2016-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204572-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2016-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204572-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2016-03-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204572-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2016-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204572-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2016-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204572-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2016-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204572-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2016-03-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204572-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2016-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204572-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2016-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204572-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2016-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204572-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2016-03-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204572-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2016-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204572-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2016-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204572-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2016-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204572-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2016-03-25 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Rivastigmine Tartrate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RIVASTIGMINE TARTRATE 1.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9IY2357JPE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 314214 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 0904-7107-61 Rivastigmine Tartrate 100 in 1 CARTON CAPSULE 100 4 0904-7107-61 Rivastigmine Tartrate 1 in 1 BLISTER PACK CAPSULE 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7107 RIVASTIGMINE TARTRATE CAPSULE [MAJOR PHARMACEUTICALS] 4 Current NDC, Legacy NDC, 2 package rows 20250308_39aadc39-0f4f-44f7-88de-83a0ea2ac332.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 · 2 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 0904-7107-61 00904710761 100 BLISTER PACK in 1 CARTON (0904-7107-61) / 1 CAPSULE in 1 BLISTER PACK 100 blister pack 2016-03-25 0000-00-00 No No Current