Home NDC 33342-091 RIVASTIGMINE TARTRATE
Product NDC 33342-091
11-digit product format 333420091
Labeler code 33342
Product ID 33342-091_3ac90f1e-d2a5-4645-972b-0d627e4cc860
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name RIVASTIGMINE TARTRATE
Dosage form CAPSULE
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA203148
Marketing category ANDA
Marketing start 2014-09-02
Substance RIVASTIGMINE TARTRATE
Active strength 4.5 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 A203148-001 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2014-08-22 A203148-002 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2014-08-22 A203148-003 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2014-08-22 A203148-004 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2014-08-22
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 A203148-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2014-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203148-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2014-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203148-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2014-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203148-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2014-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203148-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2014-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203148-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2014-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203148-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2014-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203148-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2014-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203148-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2014-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203148-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2014-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203148-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2014-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203148-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2014-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203148-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2014-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203148-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2014-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203148-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2014-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203148-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2014-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203148-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2014-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203148-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2014-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203148-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2014-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203148-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2014-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203148-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2014-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203148-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2014-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203148-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2014-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203148-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2014-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203148-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2014-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203148-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2014-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203148-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2014-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203148-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2014-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203148-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2014-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203148-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2014-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203148-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2014-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203148-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2014-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203148-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2014-08-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203148-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2014-08-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203148-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2014-08-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203148-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2014-08-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203148-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2014-08-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203148-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2014-08-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203148-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2014-08-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203148-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2014-08-22 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 4.5 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312835 Internal RxNorm lookup 312836 Internal RxNorm lookup 314214 Internal RxNorm lookup 314215 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 33342-091-06 RIVASTIGMINE TARTRATE 10 in 1 BLISTER PACK CAPSULE 10 7 33342-091-06 RIVASTIGMINE TARTRATE 3 in 1 BOX, UNIT-DOSE CAPSULE 3 7 33342-091-09 RIVASTIGMINE TARTRATE 60 in 1 BOTTLE CAPSULE 60 7 33342-091-12 RIVASTIGMINE TARTRATE 10 in 1 BLISTER PACK CAPSULE 10 7 33342-091-12 RIVASTIGMINE TARTRATE 10 in 1 BOX, UNIT-DOSE CAPSULE 10 7 33342-091-15 RIVASTIGMINE TARTRATE 500 in 1 BOTTLE CAPSULE 500 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-091 RIVASTIGMINE TARTRATE CAPSULE [MACLEODS PHARMACEUTICALS LIMITED] 7 Current NDC, Legacy NDC, 6 package rows 20220902_4364f6ef-a8da-4805-be0d-aabbe8ca2d21.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 · 1 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 33342-091-06 33342009106 3 BLISTER PACK in 1 BOX, UNIT-DOSE (33342-091-06) / 10 CAPSULE in 1 BLISTER PACK 3 blister pack 2014-09-02 0000-00-00 No No Current 33342-091-09 33342009109 60 CAPSULE in 1 BOTTLE (33342-091-09) 60 capsule 2014-09-02 0000-00-00 No No Current 33342-091-12 33342009112 10 BLISTER PACK in 1 BOX, UNIT-DOSE (33342-091-12) / 10 CAPSULE in 1 BLISTER PACK 10 blister pack 2014-09-02 0000-00-00 No No Current 33342-091-15 33342009115 500 CAPSULE in 1 BOTTLE (33342-091-15) 500 capsule 2014-09-02 0000-00-00 No No Current