Rivastigmine Tartrate

Product NDC
71209-014
11-digit product format
712090014
Labeler code
71209
Product ID
71209-014_862f0b42-695e-4170-983d-cfb848967cf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivastigmine Tartrate
Dosage form
CAPSULE
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA203844
Marketing category
ANDA
Marketing start
2014-02-11
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

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
A203844-001RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-02-13
A203844-002RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-02-13
A203844-003RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-02-13
A203844-004RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-02-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203844-001AB
A203844-002AB
A203844-003AB
A203844-004AB

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 UTC2026-02A203844-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203844-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203844-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203844-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-02-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203844-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203844-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203844-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203844-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-02-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A203844-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203844-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203844-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203844-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-02-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203844-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203844-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203844-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203844-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-02-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203844-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203844-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203844-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203844-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-02-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203844-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203844-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203844-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203844-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-02-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203844-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203844-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203844-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203844-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-02-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203844-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203844-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203844-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203844-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-02-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203844-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-02-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203844-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-02-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203844-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-02-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203844-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-02-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203844-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-02-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A203844-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-02-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A203844-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-02-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A203844-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-02-13d06236e962d9…

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 UTC2026-02A203844-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203844-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203844-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203844-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203844-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203844-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203844-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203844-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203844-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203844-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203844-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203844-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203844-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203844-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203844-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203844-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203844-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203844-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203844-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203844-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203844-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203844-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203844-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203844-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203844-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203844-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203844-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203844-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203844-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203844-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203844-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203844-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203844-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203844-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203844-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203844-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203844-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203844-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203844-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203844-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIVASTIGMINE TARTRATE4.5 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
e7e641fe-39bd-4681-a430-6dedeb6d6af5Available 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
71209-014-03Rivastigmine Tartrate60 in 1 BOTTLECAPSULE606
71209-014-10Rivastigmine Tartrate500 in 1 BOTTLECAPSULE5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-014RIVASTIGMINE TARTRATE CAPSULE [CADILA PHARMACEUTICALS LIMITED]6Current NDC, Legacy NDC, 2 package rows20221230_e7e641fe-39bd-4681-a430-6dedeb6d6af5.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rivastigmine TartrateRIVASTIGMINE TARTRATECadila Pharmaceuticals Limitede7e641fe-39bd-4681-a430-6dedeb6d6af52022-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203844
application number: ANDA203844
ndc (product): 71209-014
Rivastigmine TartrateRIVASTIGMINE TARTRATEModavar Pharmaceuticals LLC209f3b02-0acf-46e9-b355-91c918a20eb32022-12-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203844
application number: ANDA203844
RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATENivagen Pharmaceuticals, Inc.83bd2ff6-1d8b-4cac-a37b-fd01dc3f34a12022-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203844
application number: ANDA203844

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314214rivastigmine tartrate 1.5 MG Oral CapsulePSNe7e641fe-39bd-4681-a430-6dedeb6d6af56
312835rivastigmine tartrate 3 MG Oral CapsulePSNe7e641fe-39bd-4681-a430-6dedeb6d6af56
314215rivastigmine tartrate 4.5 MG Oral CapsulePSNe7e641fe-39bd-4681-a430-6dedeb6d6af56
312836rivastigmine tartrate 6 MG Oral CapsulePSNe7e641fe-39bd-4681-a430-6dedeb6d6af56
314214rivastigmine 1.5 MG Oral CapsuleSCDe7e641fe-39bd-4681-a430-6dedeb6d6af56
312835rivastigmine 3 MG Oral CapsuleSCDe7e641fe-39bd-4681-a430-6dedeb6d6af56
314215rivastigmine 4.5 MG Oral CapsuleSCDe7e641fe-39bd-4681-a430-6dedeb6d6af56
312836rivastigmine 6 MG Oral CapsuleSCDe7e641fe-39bd-4681-a430-6dedeb6d6af56
314214rivastigmine 1.5 MG (as rivastigmine tartrate) Oral CapsuleSYe7e641fe-39bd-4681-a430-6dedeb6d6af56
312835rivastigmine 3 MG (as rivastigmine tartrate) Oral CapsuleSYe7e641fe-39bd-4681-a430-6dedeb6d6af56
314215rivastigmine 4.5 MG (as rivastigmine tartrate) Oral CapsuleSYe7e641fe-39bd-4681-a430-6dedeb6d6af56
312836rivastigmine 6 MG (as rivastigmine tartrate) Oral CapsuleSYe7e641fe-39bd-4681-a430-6dedeb6d6af56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71209-014-037120900140360 CAPSULE in 1 BOTTLE (71209-014-03) 60 capsule2014-02-110000-00-00NoNoCurrent
71209-014-1071209001410500 CAPSULE in 1 BOTTLE (71209-014-10) 500 capsule2014-02-110000-00-00NoNoCurrent