Home NDC 65862-878 Solifenacin Succinate
Product NDC 65862-878
11-digit product format 658620878
Labeler code 65862
Product ID 65862-878_ececaabb-2b01-4ef5-b5e8-a927478deccc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Solifenacin Succinate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA206817
Marketing category ANDA
Marketing start 2022-12-27
Substance SOLIFENACIN SUCCINATE
Active strength 5 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206817-001 SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2022-12-27 A206817-002 SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2022-12-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 48 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A206817-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2022-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206817-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2022-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206817-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2022-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206817-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2022-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206817-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2022-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206817-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2022-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206817-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2022-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206817-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2022-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206817-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2022-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206817-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2022-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206817-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2022-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206817-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2022-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206817-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2022-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206817-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2022-12-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206817-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2022-12-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206817-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2022-12-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206817-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2022-12-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206817-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2022-12-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206817-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2022-12-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206817-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2022-12-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206817-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2022-12-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206817-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2022-12-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206817-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2022-12-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206817-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2022-12-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206817-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2022-12-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206817-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2022-12-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206817-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2022-12-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206817-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2022-12-27 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206817-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2022-12-27 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206817-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2022-12-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206817-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2022-12-27 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A206817-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2022-12-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206817-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2022-12-27 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A206817-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2022-12-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206817-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2022-12-27 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206817-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2022-12-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206817-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2022-12-27 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206817-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2022-12-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206817-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2022-12-27 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206817-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2022-12-27 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Solifenacin Succinate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SOLIFENACIN SUCCINATE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination KKA5DLD701 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 477367 Internal RxNorm lookup 477372 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65862-878-03 Solifenacin Succinate 3 in 1 CARTON TABLET, FILM COATED 3 3 65862-878-10 Solifenacin Succinate 10 in 1 BLISTER PACK TABLET, FILM COATED 10 3 65862-878-30 Solifenacin Succinate 30 in 1 BOTTLE TABLET, FILM COATED 30 3 65862-878-90 Solifenacin Succinate 90 in 1 BOTTLE TABLET, FILM COATED 90 3 65862-878-99 Solifenacin Succinate 1000 in 1 BOTTLE TABLET, FILM COATED 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-878 SOLIFENACIN SUCCINATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 3 Current NDC, Legacy NDC, 5 package rows 20240510_92b37f2d-b1cf-49e6-a13b-0ead92c0604c.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65862-878-03 65862087803 3 BLISTER PACK in 1 CARTON (65862-878-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-878-10) 3 blister pack 2022-12-27 0000-00-00 No No Current 65862-878-10 65862087810 10 in 1 BLISTER PACK Historical 65862-878-30 65862087830 30 TABLET, FILM COATED in 1 BOTTLE (65862-878-30) 2022-12-27 0000-00-00 No No Current 65862-878-90 65862087890 90 TABLET, FILM COATED in 1 BOTTLE (65862-878-90) 2022-12-27 0000-00-00 No No Current 65862-878-99 65862087899 1000 TABLET, FILM COATED in 1 BOTTLE (65862-878-99) 2022-12-27 0000-00-00 No No Current