Solifenacin Succinate Tablets

Manufacturer
Zydus Lifesciences Limited
Effective date
2022-10-17
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:51:20

Label at a glance#

ProductSolifenacin
Active ingredientSOLIFENACIN SUCCINATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1604-3

Solifenacin succinate tablets, 5 mg

Rx only

30 tablets

5 mg
5 mg

NDC 70771-1605-3

Solifenacin succinate tablets, 10 mg

Rx only

30 tablets

10 mg
10 mg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-160470771-1604-3, 70771-1604-9
70771-160570771-1605-9, 70771-1605-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A207721-001SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-10-19
A207721-002SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-10-19

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 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207721-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-10-1984e616aacf4f…
2026-09-14 22:38:342026-08A207721-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-10-1984e616aacf4f…
2026-08-18 06:07:402026-07A207721-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07A207721-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-10-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207721-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207721-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-10-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207721-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207721-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-10-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A207721-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207721-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-10-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207721-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207721-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-10-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207721-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207721-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-10-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207721-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207721-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-10-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207721-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207721-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-10-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207721-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207721-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-10-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207721-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207721-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-10-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207721-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A207721-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-10-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207721-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-10-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207721-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-10-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207721-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-10-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207721-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-10-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207721-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-10-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207721-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-10-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207721-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-10-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207721-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-10-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207721-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-10-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207721-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-10-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207721-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-10-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207721-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-10-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207721-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-10-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207721-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-10-194b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A207721-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-10-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207721-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-10-19bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2021-03-12 10:30 UTC2021-03A207721-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A207721-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207721-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A207721-002AB18869cabd3fbd…

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
a6d26fd8-87f2-4ee3-9e70-aeba705c60d6686105dc-03e0-4e11-bb55-52a0460ab2622024-12-04Exact identifier
spl set id: 686105dc-03e0-4e11-bb55-52a0460ab262

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.