Rivastigmine Tartrate

Product NDC
55111-352
11-digit product format
551110352
Labeler code
55111
Product ID
55111-352_b6b13871-d413-7582-bd37-090b800d61f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivastigmine Tartrate
Dosage form
CAPSULE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA077130
Marketing category
ANDA
Marketing start
2011-09-01
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
A077130-001RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALABRS2007-10-31
A077130-002RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2007-10-31
A077130-003RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2007-10-31
A077130-004RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALABRS2007-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077130-001AB
A077130-002AB
A077130-003AB
A077130-004AB

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 UTC2026-02A077130-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALABRS2007-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077130-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2007-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077130-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2007-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077130-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALABRS2007-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077130-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALABRS2007-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077130-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2007-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077130-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2007-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077130-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALABRS2007-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077130-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALABRS2007-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077130-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2007-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077130-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2007-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077130-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALABRS2007-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077130-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALABRS2007-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077130-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2007-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077130-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2007-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077130-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALABRS2007-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077130-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALABRS2007-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077130-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2007-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077130-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2007-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077130-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALABRS2007-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077130-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALABRS2007-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077130-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2007-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077130-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2007-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077130-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALABRS2007-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077130-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALABRS2007-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077130-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2007-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077130-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2007-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077130-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALABRS2007-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077130-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALABRS2007-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077130-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2007-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077130-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2007-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077130-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALABRS2007-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077130-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALABRS2007-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077130-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2007-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077130-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2007-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077130-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALABRS2007-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077130-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALABRS2007-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A077130-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2007-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A077130-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2007-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A077130-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALABRS2007-10-31d06236e962d9…

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 UTC2026-02A077130-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077130-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077130-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077130-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077130-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077130-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077130-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077130-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077130-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077130-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077130-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077130-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077130-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077130-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077130-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077130-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077130-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077130-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077130-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077130-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077130-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077130-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077130-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077130-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077130-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077130-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077130-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077130-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077130-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077130-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077130-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077130-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077130-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077130-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077130-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077130-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077130-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077130-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077130-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077130-004AB1d06236e962d9…

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
0e20124c-725a-0145-996c-2ff908703162Available 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
55111-352-01Rivastigmine Tartrate100 in 1 BOTTLECAPSULE1009
55111-352-05Rivastigmine Tartrate500 in 1 BOTTLECAPSULE5009
55111-352-30Rivastigmine Tartrate30 in 1 BOTTLECAPSULE309
55111-352-60Rivastigmine Tartrate60 in 1 BOTTLECAPSULE609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-352-05EA - Each55111-35252117571-0616-49c5-b4b4-b3745c1f3c5b12012-07-24
55111-352-60EA - Each55111-352fcdb313a-5924-4d86-a0ff-e240272877f312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
rivastigmine tartrateACTIVE INGREDIENT9IY2357JPERIVASTIGMINE TARTRATE (RIVASTIGMINE TARTRATE ) CAPSULE [DR. REDDY'S LABORATORIES LIMITED]6
rivastigmineACTIVE MOIETYPKI06M3IW0RIVASTIGMINE TARTRATE (RIVASTIGMINE TARTRATE ) CAPSULE [DR. REDDY'S LABORATORIES LIMITED]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIVASTIGMINE TARTRATE (RIVASTIGMINE TARTRATE ) CAPSULE [DR. REDDY'S LABORATORIES LIMITED]6
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4RIVASTIGMINE TARTRATE (RIVASTIGMINE TARTRATE ) CAPSULE [DR. REDDY'S LABORATORIES LIMITED]6
ferric oxide redINACTIVE INGREDIENT1K09F3G675RIVASTIGMINE TARTRATE (RIVASTIGMINE TARTRATE ) CAPSULE [DR. REDDY'S LABORATORIES LIMITED]6
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTRIVASTIGMINE TARTRATE (RIVASTIGMINE TARTRATE ) CAPSULE [DR. REDDY'S LABORATORIES LIMITED]6
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357RIVASTIGMINE TARTRATE (RIVASTIGMINE TARTRATE ) CAPSULE [DR. REDDY'S LABORATORIES LIMITED]6
gelatinINACTIVE INGREDIENT2G86QN327LRIVASTIGMINE TARTRATE (RIVASTIGMINE TARTRATE ) CAPSULE [DR. REDDY'S LABORATORIES LIMITED]6
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4RIVASTIGMINE TARTRATE (RIVASTIGMINE TARTRATE ) CAPSULE [DR. REDDY'S LABORATORIES LIMITED]6
magnesium stearateINACTIVE INGREDIENT70097M6I30RIVASTIGMINE TARTRATE (RIVASTIGMINE TARTRATE ) CAPSULE [DR. REDDY'S LABORATORIES LIMITED]6
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPRIVASTIGMINE TARTRATE (RIVASTIGMINE TARTRATE ) CAPSULE [DR. REDDY'S LABORATORIES LIMITED]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-352RIVASTIGMINE TARTRATE (RIVASTIGMINE TARTRATE ) CAPSULE [DR. REDDY'S LABORATORIES LIMITED]9Current NDC, Legacy NDC, 4 package rows20190125_0e20124c-725a-0145-996c-2ff908703162.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 TARTRATEAmerican Health Packaging52781229-ee82-43f9-a113-4419a611978d2025-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077130
application number: ANDA077130
Rivastigmine TartrateRIVASTIGMINE TARTRATEDr. Reddy's Laboratories Limited0e20124c-725a-0145-996c-2ff9087031622019-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077130
application number: ANDA077130
ndc (product): 55111-352

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314214rivastigmine tartrate 1.5 MG Oral CapsulePSN0e20124c-725a-0145-996c-2ff9087031629
312835rivastigmine tartrate 3 MG Oral CapsulePSN0e20124c-725a-0145-996c-2ff9087031629
314215rivastigmine tartrate 4.5 MG Oral CapsulePSN0e20124c-725a-0145-996c-2ff9087031629
312836rivastigmine tartrate 6 MG Oral CapsulePSN0e20124c-725a-0145-996c-2ff9087031629
314214rivastigmine 1.5 MG Oral CapsuleSCD0e20124c-725a-0145-996c-2ff9087031629
312835rivastigmine 3 MG Oral CapsuleSCD0e20124c-725a-0145-996c-2ff9087031629
314215rivastigmine 4.5 MG Oral CapsuleSCD0e20124c-725a-0145-996c-2ff9087031629
312836rivastigmine 6 MG Oral CapsuleSCD0e20124c-725a-0145-996c-2ff9087031629
314214rivastigmine 1.5 MG (as rivastigmine tartrate) Oral CapsuleSY0e20124c-725a-0145-996c-2ff9087031629
312835rivastigmine 3 MG (as rivastigmine tartrate) Oral CapsuleSY0e20124c-725a-0145-996c-2ff9087031629
314215rivastigmine 4.5 MG (as rivastigmine tartrate) Oral CapsuleSY0e20124c-725a-0145-996c-2ff9087031629
312836rivastigmine 6 MG (as rivastigmine tartrate) Oral CapsuleSY0e20124c-725a-0145-996c-2ff9087031629
314214rivastigmine tartrate 1.5 MG Oral CapsulePSN52781229-ee82-43f9-a113-4419a611978d2
314214rivastigmine 1.5 MG Oral CapsuleSCD52781229-ee82-43f9-a113-4419a611978d2
314214rivastigmine 1.5 MG (as rivastigmine tartrate) Oral CapsuleSY52781229-ee82-43f9-a113-4419a611978d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-352-0155111035201100 CAPSULE in 1 BOTTLE (55111-352-01) 100 capsule2011-09-010000-00-00NoNoCurrent
55111-352-0555111035205500 CAPSULE in 1 BOTTLE (55111-352-05) 500 capsule2011-09-010000-00-00NoNoCurrent
55111-352-305511103523030 CAPSULE in 1 BOTTLE (55111-352-30) 30 capsule2011-09-010000-00-00NoNoCurrent
55111-352-605511103526060 CAPSULE in 1 BOTTLE (55111-352-60) 60 capsule2011-09-010000-00-00NoNoCurrent