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#
Label contents#
Full prescribing information#
Products#
Every source-derived product name is available through these pages.
- Solifenacin
- SOLIFENACIN SUCCINATE
- FERRIC OXIDE YELLOW
- HYPROMELLOSES
- LACTOSE MONOHYDRATE
- MAGNESIUM STEARATE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- STARCH, CORN
- TALC
- TITANIUM DIOXIDE
- FERRIC OXIDE RED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70771-1604 | 70771-1604-3, 70771-1604-9 |
| 70771-1605 | 70771-1605-9, 70771-1605-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207721-001 | SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET / ORAL | 2020-10-19 | ||
| A207721-002 | SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET / ORAL | 2020-10-19 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A207721-001 | SOLIFENACIN SUCCINATE | 5MG | TABLET / ORAL | 2020-10-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A207721-002 | SOLIFENACIN SUCCINATE | 10MG | TABLET / ORAL | 2020-10-19 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207721-001 | SOLIFENACIN SUCCINATE | 5MG | TABLET / ORAL | 2020-10-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207721-002 | SOLIFENACIN SUCCINATE | 10MG | TABLET / ORAL | 2020-10-19 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207721-001 | SOLIFENACIN SUCCINATE | 5MG | TABLET / ORAL | 2020-10-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207721-002 | SOLIFENACIN SUCCINATE | 10MG | TABLET / ORAL | 2020-10-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207721-001 | SOLIFENACIN SUCCINATE | 5MG | TABLET / ORAL | 2020-10-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207721-002 | SOLIFENACIN SUCCINATE | 10MG | TABLET / ORAL | 2020-10-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207721-001 | SOLIFENACIN SUCCINATE | 5MG | TABLET / ORAL | 2020-10-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207721-002 | SOLIFENACIN SUCCINATE | 10MG | TABLET / ORAL | 2020-10-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207721-001 | SOLIFENACIN SUCCINATE | 5MG | TABLET / ORAL | 2020-10-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207721-002 | SOLIFENACIN SUCCINATE | 10MG | TABLET / ORAL | 2020-10-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207721-001 | SOLIFENACIN SUCCINATE | 5MG | TABLET / ORAL | 2020-10-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207721-002 | SOLIFENACIN SUCCINATE | 10MG | TABLET / ORAL | 2020-10-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207721-001 | SOLIFENACIN SUCCINATE | 5MG | TABLET / ORAL | 2020-10-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207721-002 | SOLIFENACIN SUCCINATE | 10MG | TABLET / ORAL | 2020-10-19 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207721-001 | SOLIFENACIN SUCCINATE | 5MG | TABLET / ORAL | 2020-10-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207721-002 | SOLIFENACIN SUCCINATE | 10MG | TABLET / ORAL | 2020-10-19 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207721-001 | SOLIFENACIN SUCCINATE | 5MG | TABLET / ORAL | 2020-10-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207721-002 | SOLIFENACIN SUCCINATE | 10MG | TABLET / ORAL | 2020-10-19 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207721-001 | SOLIFENACIN SUCCINATE | 5MG | TABLET / ORAL | 2020-10-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207721-002 | SOLIFENACIN SUCCINATE | 10MG | TABLET / ORAL | 2020-10-19 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207721-001 | SOLIFENACIN SUCCINATE | 5MG | TABLET / ORAL | 2020-10-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207721-002 | SOLIFENACIN SUCCINATE | 10MG | TABLET / ORAL | 2020-10-19 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207721-001 | SOLIFENACIN SUCCINATE | 5MG | TABLET / ORAL | 2020-10-19 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207721-002 | SOLIFENACIN SUCCINATE | 10MG | TABLET / ORAL | 2020-10-19 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207721-001 | SOLIFENACIN SUCCINATE | 5MG | TABLET / ORAL | 2020-10-19 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207721-002 | SOLIFENACIN SUCCINATE | 10MG | TABLET / ORAL | 2020-10-19 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207721-001 | SOLIFENACIN SUCCINATE | 5MG | TABLET / ORAL | 2020-10-19 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207721-002 | SOLIFENACIN SUCCINATE | 10MG | TABLET / ORAL | 2020-10-19 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207721-001 | SOLIFENACIN SUCCINATE | 5MG | TABLET / ORAL | 2020-10-19 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207721-002 | SOLIFENACIN SUCCINATE | 10MG | TABLET / ORAL | 2020-10-19 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207721-001 | SOLIFENACIN SUCCINATE | 5MG | TABLET / ORAL | 2020-10-19 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207721-002 | SOLIFENACIN SUCCINATE | 10MG | TABLET / ORAL | 2020-10-19 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207721-001 | SOLIFENACIN SUCCINATE | 5MG | TABLET / ORAL | 2020-10-19 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207721-002 | SOLIFENACIN SUCCINATE | 10MG | TABLET / ORAL | 2020-10-19 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207721-001 | SOLIFENACIN SUCCINATE | 5MG | TABLET / ORAL | 2020-10-19 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207721-002 | SOLIFENACIN SUCCINATE | 10MG | TABLET / ORAL | 2020-10-19 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207721-001 | SOLIFENACIN SUCCINATE | 5MG | TABLET / ORAL | 2020-10-19 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207721-002 | SOLIFENACIN SUCCINATE | 10MG | TABLET / ORAL | 2020-10-19 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2021-03-12 10:30 UTC | 2021-03 | A207721-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A207721-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A207721-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A207721-002 | AB | 1 | 8869cabd3fbd… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| a6d26fd8-87f2-4ee3-9e70-aeba705c60d6 | 686105dc-03e0-4e11-bb55-52a0460ab262 | 2024-12-04 | 686105dc-03e0-4e11-bb55-52a0460ab262 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

