Solifenacin Succinate

Product NDC
67877-528
11-digit product format
678770528
Labeler code
67877
Product ID
67877-528_e0e2cc86-60c8-450a-86f8-c551308ff027
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Solifenacin Succinate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA210224
Marketing category
ANDA
Marketing start
2019-05-21
Substance
SOLIFENACIN SUCCINATE
Active strength
10 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210224-001SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-20
A210224-002SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A210224-001AB
A210224-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210224-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210224-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210224-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210224-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A210224-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210224-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210224-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210224-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210224-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210224-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210224-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210224-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210224-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210224-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210224-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210224-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210224-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210224-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210224-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A210224-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210224-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210224-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210224-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210224-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210224-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210224-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210224-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210224-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210224-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210224-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210224-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210224-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210224-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210224-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210224-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210224-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210224-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210224-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210224-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-20782e0a99824c…
2021-12-28 21:50 UTC2021-12A210224-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-20782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210224-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210224-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210224-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210224-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210224-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210224-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210224-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210224-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210224-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210224-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210224-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210224-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210224-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210224-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210224-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210224-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210224-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210224-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210224-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210224-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210224-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210224-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210224-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210224-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210224-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210224-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210224-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210224-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210224-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210224-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210224-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210224-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210224-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210224-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210224-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210224-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210224-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210224-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210224-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A210224-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Solifenacin Succinate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOLIFENACIN SUCCINATE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KKA5DLD701Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
477367Internal RxNorm lookup
477372Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
97d8a21e-4618-460f-8cf5-97a9d946039eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efc179d5-753a-8dcd-90d4-5676a1c31ce3Product name720250423
7a525cfb-2fd5-4f2e-bf22-13a2c0cea1ddProduct name120201030

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-528-30Solifenacin Succinate30 in 1 BOTTLETABLET, FILM COATED309
67877-528-33Solifenacin Succinate10 in 1 BLISTER PACKTABLET, FILM COATED109
67877-528-38Solifenacin Succinate10 in 1 CARTONTABLET, FILM COATED109
67877-528-90Solifenacin Succinate90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-528-30EA - Each67877-528ef678064-9dd8-4cce-9c0f-8561374022d812019-06-19
67877-528-90EA - Each67877-528b5790ad0-36fc-4685-ada6-254cee69ac1d12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-528SOLIFENACIN SUCCINATE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8Current NDC, Legacy NDC, 4 package rows20240521_97d8a21e-4618-460f-8cf5-97a9d946039e.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Solifenacin SuccinateSOLIFENACIN SUCCINATEBryant Ranch Prepackf0b8f111-1d76-4b04-9e2f-9fca9e5a0b002025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210224
application number: ANDA210224
Solifenacin SuccinateSOLIFENACIN SUCCINATEBryant Ranch Prepacke04812c2-2ff7-4dff-9122-518c18f4935e2025-11-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210224
application number: ANDA210224
Solifenacin SuccinateSOLIFENACIN SUCCINATEBryant Ranch Prepack3788df43-42dd-4778-8289-e32b5844358e2025-11-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210224
application number: ANDA210224
Solifenacin SuccinateSOLIFENACIN SUCCINATEBryant Ranch Prepackdadb9462-953e-4319-b9f8-5b7255d1cf9c2025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210224
application number: ANDA210224
Solifenacin SuccinateSOLIFENACIN SUCCINATEBryant Ranch Prepack8d65dcb9-aa67-4cfb-9d15-43d0de327bd72025-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210224
application number: ANDA210224
Solifenacin SuccinateSOLIFENACIN SUCCINATEBryant Ranch Prepack2462e9a4-66a7-4340-9a81-617f3417b4952025-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210224
application number: ANDA210224
Solifenacin SuccinateSOLIFENACIN SUCCINATEBryant Ranch Prepack663d992d-23cc-4a8e-acd5-a4bea505ba3a2025-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210224
application number: ANDA210224
Solifenacin SuccinateSOLIFENACIN SUCCINATEBryant Ranch Prepack2dfc5d69-8f35-4f57-90b7-46a5f0f0febe2025-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210224
application number: ANDA210224
Solifenacin SuccinateSOLIFENACIN SUCCINATEAscend Laboratories, LLC97d8a21e-4618-460f-8cf5-97a9d946039e2025-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210224
application number: ANDA210224
ndc (product): 67877-528
Solifenacin SuccinateSOLIFENACIN SUCCINATEProficient Rx LPc67107f4-348b-4a23-a67c-26fd8241ebd62022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210224
application number: ANDA210224

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477372solifenacin succinate 10 MG Oral TabletPSN2462e9a4-66a7-4340-9a81-617f3417b495105
477372solifenacin succinate 10 MG Oral TabletPSN663d992d-23cc-4a8e-acd5-a4bea505ba3a105
477372solifenacin succinate 10 MG Oral TabletSCD2462e9a4-66a7-4340-9a81-617f3417b495105
477372solifenacin succinate 10 MG Oral TabletSCD663d992d-23cc-4a8e-acd5-a4bea505ba3a105
477372solifenacin succinate 10 MG Oral TabletPSNe04812c2-2ff7-4dff-9122-518c18f4935e102
477372solifenacin succinate 10 MG Oral TabletSCDe04812c2-2ff7-4dff-9122-518c18f4935e102
477372solifenacin succinate 10 MG Oral TabletPSNf0b8f111-1d76-4b04-9e2f-9fca9e5a0b00100
477372solifenacin succinate 10 MG Oral TabletSCDf0b8f111-1d76-4b04-9e2f-9fca9e5a0b00100
477372solifenacin succinate 10 MG Oral TabletPSN97d8a21e-4618-460f-8cf5-97a9d946039e9
477367solifenacin succinate 5 MG Oral TabletPSN97d8a21e-4618-460f-8cf5-97a9d946039e9
477372solifenacin succinate 10 MG Oral TabletSCD97d8a21e-4618-460f-8cf5-97a9d946039e9
477367solifenacin succinate 5 MG Oral TabletSCD97d8a21e-4618-460f-8cf5-97a9d946039e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-528-306787705283030 TABLET, FILM COATED in 1 BOTTLE (67877-528-30) 2019-05-210000-00-00NoNoCurrent
67877-528-336787705283310 in 1 BLISTER PACKHistorical
67877-528-386787705283810 BLISTER PACK in 1 CARTON (67877-528-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-528-33) 10 blister pack2019-05-210000-00-00NoNoCurrent
67877-528-906787705289090 TABLET, FILM COATED in 1 BOTTLE (67877-528-90) 2019-05-210000-00-00NoNoCurrent