Rivastigmine Tartrate

Product NDC
0904-6587
11-digit product format
009046587
Labeler code
0904
Product ID
0904-6587_a5af2407-f27d-46a0-9c90-880c14d002f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivastigmine Tartrate
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA077129
Marketing category
ANDA
Marketing start
2010-07-01
Marketing end
0000-00-00
Substance
RIVASTIGMINE TARTRATE
Active strength
2 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0904-6587DDiscontinued by firm2026-08-10
excluded packagepackage0904-65870904-6587-61DDiscontinued by firm2026-08-10

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0904-6587-61d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-6587-61f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-6587-612ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-6587-61a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-6587-61cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-6587-61cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-6587-61302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-6587-61ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-6587-610efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-6587-61ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-6587-61367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-6587-61557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077129-001RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2008-01-08
A077129-002RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2008-01-08
A077129-003RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2008-01-08
A077129-004RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2008-01-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A077129-001AB
A077129-002AB
A077129-003AB
A077129-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077129-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2008-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077129-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2008-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077129-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2008-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077129-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2008-01-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077129-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2008-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077129-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2008-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077129-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2008-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077129-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2008-01-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077129-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2008-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077129-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2008-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077129-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2008-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077129-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2008-01-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077129-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2008-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077129-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2008-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077129-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2008-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077129-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2008-01-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077129-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2008-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077129-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2008-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077129-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2008-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077129-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2008-01-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077129-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2008-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077129-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2008-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077129-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2008-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077129-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2008-01-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077129-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2008-01-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077129-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2008-01-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077129-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2008-01-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077129-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2008-01-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077129-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2008-01-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077129-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2008-01-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077129-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2008-01-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077129-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2008-01-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077129-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2008-01-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077129-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2008-01-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077129-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2008-01-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077129-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2008-01-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077129-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2008-01-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A077129-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2008-01-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A077129-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2008-01-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A077129-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2008-01-08d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077129-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077129-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077129-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077129-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077129-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077129-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077129-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077129-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077129-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077129-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077129-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077129-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077129-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077129-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077129-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077129-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077129-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077129-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077129-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077129-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077129-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077129-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077129-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077129-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077129-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077129-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077129-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077129-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077129-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077129-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077129-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077129-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077129-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077129-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077129-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077129-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077129-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077129-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077129-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077129-004AB1d06236e962d9…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6587-61EA - Each0904-65879ac9c7d0-980b-4db1-8491-2d5d7deb186812017-12-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6587-6100904658761100 BLISTER PACK in 1 CARTON (0904-6587-61) > 1 CAPSULE in 1 BLISTER PACK100 blister pack2010-07-010000-00-00NoNoCurrent