Rivastigmine Tartrate

Product NDC
62135-900
11-digit product format
621350900
Labeler code
62135
Product ID
62135-900_070bd281-9772-c587-e063-6294a90a04a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivastigmine Tartrate
Dosage form
CAPSULE
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA207797
Marketing category
ANDA
Marketing start
2017-09-28
Substance
RIVASTIGMINE TARTRATE
Active strength
1.5 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207797-001RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-09-28
A207797-002RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-09-28
A207797-003RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-09-28
A207797-004RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207797-001AB
A207797-002AB
A207797-003AB
A207797-004AB

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 UTC2026-02A207797-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207797-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207797-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207797-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207797-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207797-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207797-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207797-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A207797-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207797-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207797-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207797-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207797-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207797-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207797-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207797-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207797-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207797-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207797-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207797-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207797-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207797-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207797-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207797-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207797-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207797-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207797-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207797-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207797-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207797-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207797-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207797-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207797-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207797-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207797-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207797-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207797-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A207797-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A207797-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A207797-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-09-28d06236e962d9…

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 UTC2026-02A207797-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207797-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207797-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207797-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207797-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207797-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207797-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207797-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207797-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207797-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207797-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207797-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207797-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207797-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207797-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207797-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207797-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207797-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207797-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207797-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207797-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207797-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207797-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207797-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207797-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207797-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207797-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207797-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207797-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207797-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207797-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207797-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207797-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207797-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207797-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207797-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207797-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207797-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207797-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207797-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIVASTIGMINE TARTRATE1.5 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
2bb5e0d6-f677-4021-9888-3ff90979ef7dAvailable 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
62135-900-60Rivastigmine Tartrate60 in 1 BOTTLECAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-900-60EA - Each62135-900b352f82f-05eb-47b2-9d28-0879e6c207ca12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-900RIVASTIGMINE TARTRATE CAPSULE [CHARTWELL RX, LLC]2Current NDC, 1 package rows20231007_2bb5e0d6-f677-4021-9888-3ff90979ef7d.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rivastigmine TartrateRIVASTIGMINE TARTRATEChartwell RX, LLC2bb5e0d6-f677-4021-9888-3ff90979ef7d2023-10-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207797
application number: ANDA207797
ndc (product): 62135-900

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314214rivastigmine tartrate 1.5 MG Oral CapsulePSN2bb5e0d6-f677-4021-9888-3ff90979ef7d2
312835rivastigmine tartrate 3 MG Oral CapsulePSN2bb5e0d6-f677-4021-9888-3ff90979ef7d2
314215rivastigmine tartrate 4.5 MG Oral CapsulePSN2bb5e0d6-f677-4021-9888-3ff90979ef7d2
312836rivastigmine tartrate 6 MG Oral CapsulePSN2bb5e0d6-f677-4021-9888-3ff90979ef7d2
314214rivastigmine 1.5 MG Oral CapsuleSCD2bb5e0d6-f677-4021-9888-3ff90979ef7d2
312835rivastigmine 3 MG Oral CapsuleSCD2bb5e0d6-f677-4021-9888-3ff90979ef7d2
314215rivastigmine 4.5 MG Oral CapsuleSCD2bb5e0d6-f677-4021-9888-3ff90979ef7d2
312836rivastigmine 6 MG Oral CapsuleSCD2bb5e0d6-f677-4021-9888-3ff90979ef7d2
314214rivastigmine 1.5 MG (as rivastigmine tartrate) Oral CapsuleSY2bb5e0d6-f677-4021-9888-3ff90979ef7d2
312835rivastigmine 3 MG (as rivastigmine tartrate) Oral CapsuleSY2bb5e0d6-f677-4021-9888-3ff90979ef7d2
314215rivastigmine 4.5 MG (as rivastigmine tartrate) Oral CapsuleSY2bb5e0d6-f677-4021-9888-3ff90979ef7d2
312836rivastigmine 6 MG (as rivastigmine tartrate) Oral CapsuleSY2bb5e0d6-f677-4021-9888-3ff90979ef7d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-900-606213509006060 CAPSULE in 1 BOTTLE (62135-900-60) 60 capsule2023-01-04NoNoCurrent