Home NDC 75834-135-60 RIVASTIGMINE TARTRATE
Product NDC 75834-135
Requested package NDC 75834-135-60
11-digit product format 758340135
Labeler code 75834
Product ID 75834-135_e272f7d1-d782-4ff1-919c-784c91ee024d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name RIVASTIGMINE TARTRATE
Dosage form CAPSULE
Route ORAL
Labeler Nivagen Pharmaceuticals, Inc.
Application ANDA203844
Marketing category ANDA
Marketing start 2017-09-04
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 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 75834-135 75834-135-60 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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 A203844-001 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2017-02-13 A203844-002 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2017-02-13 A203844-003 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2017-02-13 A203844-004 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2017-02-13
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 A203844-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2017-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203844-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2017-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203844-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2017-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203844-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2017-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203844-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2017-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203844-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2017-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203844-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2017-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203844-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2017-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203844-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2017-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203844-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2017-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203844-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2017-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203844-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2017-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203844-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2017-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203844-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2017-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203844-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2017-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203844-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2017-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203844-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2017-02-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203844-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2017-02-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203844-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2017-02-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203844-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2017-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203844-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2017-02-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203844-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2017-02-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203844-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2017-02-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203844-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2017-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203844-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2017-02-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203844-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2017-02-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203844-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2017-02-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203844-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2017-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203844-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2017-02-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203844-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2017-02-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203844-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2017-02-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203844-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2017-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203844-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2017-02-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203844-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2017-02-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203844-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2017-02-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203844-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2017-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203844-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2017-02-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203844-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2017-02-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203844-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2017-02-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203844-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2017-02-13 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 75834-135-05 RIVASTIGMINE TARTRATE 500 in 1 BOTTLE, PLASTIC CAPSULE 500 3 75834-135-60 RIVASTIGMINE TARTRATE 60 in 1 BOTTLE, PLASTIC CAPSULE 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75834-135 RIVASTIGMINE TARTRATE CAPSULE [NIVAGEN PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20220217_83bd2ff6-1d8b-4cac-a37b-fd01dc3f34a1.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.
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 75834-135-60 75834013560 60 CAPSULE in 1 BOTTLE, PLASTIC (75834-135-60) 60 capsule 2017-09-04 0000-00-00 No No Current