Rivastigmine Tartrate

Product NDC
65862-651
Requested package NDC
65862-651-39
11-digit product format
658620651
Labeler code
65862
Product ID
65862-651_41507ad1-b7a7-40be-aa24-60a95b60f988
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivastigmine Tartrate
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA204572
Marketing category
ANDA
Marketing start
2016-03-25
Substance
RIVASTIGMINE TARTRATE
Active strength
6 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
unfinished packagepackage65862-65165862-651-39UNFINISHEDActive or certified unfinished drug listing2026-08-12

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 · 21 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 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-276db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-188fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-174184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-104bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-305b2001dcd8f5…54b53d4dc9e4…

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
A204572-001RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2016-03-25
A204572-002RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2016-03-25
A204572-003RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2016-03-25
A204572-004RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2016-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204572-001AB
A204572-002AB
A204572-003AB
A204572-004AB

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 UTC2026-02A204572-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2016-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204572-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2016-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204572-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2016-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204572-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2016-03-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204572-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2016-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204572-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2016-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204572-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2016-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204572-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2016-03-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A204572-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2016-03-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204572-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2016-03-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204572-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2016-03-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204572-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2016-03-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204572-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2016-03-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204572-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2016-03-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204572-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2016-03-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204572-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2016-03-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204572-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2016-03-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204572-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2016-03-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204572-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2016-03-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204572-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2016-03-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204572-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2016-03-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204572-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2016-03-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204572-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2016-03-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204572-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2016-03-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204572-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2016-03-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204572-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2016-03-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204572-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2016-03-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204572-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2016-03-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204572-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2016-03-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204572-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2016-03-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204572-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2016-03-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204572-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2016-03-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204572-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2016-03-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204572-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2016-03-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204572-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2016-03-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204572-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2016-03-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204572-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2016-03-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A204572-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2016-03-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A204572-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2016-03-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A204572-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2016-03-25d06236e962d9…

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 UTC2026-02A204572-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204572-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204572-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204572-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204572-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204572-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204572-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204572-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204572-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204572-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204572-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204572-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204572-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204572-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204572-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204572-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204572-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204572-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204572-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204572-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204572-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204572-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204572-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204572-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204572-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204572-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204572-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204572-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204572-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204572-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204572-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204572-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204572-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204572-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204572-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204572-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204572-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204572-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204572-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204572-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Rivastigmine Tartrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIVASTIGMINE TARTRATE6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9IY2357JPEInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312835Internal RxNorm lookup
312836Internal RxNorm lookup
314214Internal RxNorm lookup
314215Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c246a0e5-1e77-41ee-a7b3-384f21f2f2e0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f5a24cc0-a293-4838-b663-7e454a66c2c3Product name520200513
64bcf1db-afe4-78b0-8e9c-f7cb25e1b791Product name620171121

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-651-05Rivastigmine Tartrate500 in 1 BOTTLECAPSULE5009
65862-651-10Rivastigmine Tartrate10 in 1 BLISTER PACKCAPSULE109
65862-651-60Rivastigmine Tartrate60 in 1 BOTTLECAPSULE609
65862-651-78Rivastigmine Tartrate10 in 1 CARTONCAPSULE109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-651-60EA - Each65862-65153050d4f-d300-4479-bf0d-a3e5d9d1a02112016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-651RIVASTIGMINE TARTRATE CAPSULE [AUROBINDO PHARMA LIMITED]9Current NDC, Legacy NDC, 4 package rows20240620_c246a0e5-1e77-41ee-a7b3-384f21f2f2e0.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rivastigmine TartrateRIVASTIGMINE TARTRATEMajor Pharmaceuticals39aadc39-0f4f-44f7-88de-83a0ea2ac3322025-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204572
application number: ANDA204572
Rivastigmine TartrateRIVASTIGMINE TARTRATEAurobindo Pharma Limitedc246a0e5-1e77-41ee-a7b3-384f21f2f2e02024-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204572
application number: ANDA204572
ndc (product): 65862-651

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314214rivastigmine tartrate 1.5 MG Oral CapsulePSNc246a0e5-1e77-41ee-a7b3-384f21f2f2e09
312835rivastigmine tartrate 3 MG Oral CapsulePSNc246a0e5-1e77-41ee-a7b3-384f21f2f2e09
314215rivastigmine tartrate 4.5 MG Oral CapsulePSNc246a0e5-1e77-41ee-a7b3-384f21f2f2e09
312836rivastigmine tartrate 6 MG Oral CapsulePSNc246a0e5-1e77-41ee-a7b3-384f21f2f2e09
314214rivastigmine 1.5 MG Oral CapsuleSCDc246a0e5-1e77-41ee-a7b3-384f21f2f2e09
312835rivastigmine 3 MG Oral CapsuleSCDc246a0e5-1e77-41ee-a7b3-384f21f2f2e09
314215rivastigmine 4.5 MG Oral CapsuleSCDc246a0e5-1e77-41ee-a7b3-384f21f2f2e09
312836rivastigmine 6 MG Oral CapsuleSCDc246a0e5-1e77-41ee-a7b3-384f21f2f2e09
314214rivastigmine 1.5 MG (as rivastigmine tartrate) Oral CapsuleSYc246a0e5-1e77-41ee-a7b3-384f21f2f2e09
312835rivastigmine 3 MG (as rivastigmine tartrate) Oral CapsuleSYc246a0e5-1e77-41ee-a7b3-384f21f2f2e09
314215rivastigmine 4.5 MG (as rivastigmine tartrate) Oral CapsuleSYc246a0e5-1e77-41ee-a7b3-384f21f2f2e09
312836rivastigmine 6 MG (as rivastigmine tartrate) Oral CapsuleSYc246a0e5-1e77-41ee-a7b3-384f21f2f2e09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
65862-651-39658620651393000 CAPSULE in 1 BAG (65862-651-39)3000 capsule25-MAR-16Current