Rivastigmine Tartrate

Product NDC
60687-574
Requested package NDC
60687-574-01
11-digit product format
606870574
Labeler code
60687
Product ID
60687-574_eb6b0851-c4d1-363e-e053-2a95a90a5134
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivastigmine Tartrate
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA091689
Marketing category
ANDA
Marketing start
2020-08-19
Marketing end
2024-07-31
Substance
RIVASTIGMINE TARTRATE
Active strength
2 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60687-57460687-574-01DDiscontinued by firm2026-08-11

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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

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
A091689-001RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2012-06-12
A091689-002RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2012-06-12
A091689-003RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2012-06-12
A091689-004RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2012-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091689-001AB
A091689-002AB
A091689-003AB
A091689-004AB

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 UTC2026-02A091689-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2012-06-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091689-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2012-06-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091689-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2012-06-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091689-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2012-06-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091689-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2012-06-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091689-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2012-06-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091689-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2012-06-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091689-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2012-06-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A091689-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2012-06-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091689-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2012-06-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091689-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2012-06-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091689-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2012-06-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091689-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2012-06-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091689-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2012-06-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091689-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2012-06-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091689-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2012-06-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091689-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2012-06-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091689-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2012-06-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091689-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2012-06-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091689-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2012-06-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091689-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2012-06-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091689-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2012-06-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091689-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2012-06-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091689-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2012-06-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091689-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2012-06-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091689-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2012-06-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091689-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2012-06-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091689-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2012-06-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091689-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2012-06-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091689-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2012-06-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091689-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2012-06-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091689-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2012-06-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091689-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2012-06-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091689-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2012-06-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091689-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2012-06-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091689-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2012-06-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091689-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2012-06-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A091689-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2012-06-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A091689-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2012-06-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A091689-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2012-06-12d06236e962d9…

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 UTC2026-02A091689-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091689-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091689-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091689-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091689-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091689-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091689-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091689-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091689-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091689-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091689-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091689-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091689-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091689-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091689-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091689-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091689-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091689-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091689-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091689-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091689-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091689-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091689-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091689-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091689-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091689-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091689-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091689-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091689-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091689-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091689-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091689-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091689-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091689-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091689-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091689-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091689-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091689-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091689-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091689-004AB1d06236e962d9…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-574-01EA - Each60687-5743058ce7f-d1d5-41fb-a061-90bdb39cde6e12020-09-14
60687-574-11EA - Each60687-574c5ff2363-938b-4ee0-a044-3ecbfed0c1d512020-09-14

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rivastigmine TartrateRIVASTIGMINE TARTRATEAlembic Pharmaceuticals Limited33e6a772-382d-45f5-9d45-966c077593672023-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091689
application number: ANDA091689
Rivastigmine TartrateRIVASTIGMINE TARTRATEAlembic Pharmaceuticals Inc.0044f1d7-613c-4611-8481-13032c8cb3902022-03-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091689
application number: ANDA091689

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-574-0160687057401100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-574-01) > 1 CAPSULE in 1 BLISTER PACK (60687-574-11) 100 blister pack2020-08-192024-07-31NoNoCurrent