Home NDC 69367-296-30 Solifenacin Succinate
Product NDC 69367-296
Requested package NDC 69367-296-30
11-digit product format 693670296
Labeler code 69367
Product ID 69367-296_b67b6a69-0ab9-220b-e053-2a95a90ae6ec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name solifenacin succinate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Westminster Pharmaceuticals, LLC
Application ANDA210281
Marketing category ANDA
Marketing start 2020-11-22
Marketing end 0000-00-00
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 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A210281-001 SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 A210281-002 SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20
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 3 · 82 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 A210281-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210281-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210281-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210281-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210281-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210281-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210281-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210281-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210281-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210281-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210281-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210281-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210281-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210281-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210281-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210281-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210281-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210281-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210281-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210281-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210281-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210281-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210281-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210281-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210281-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210281-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210281-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210281-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210281-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210281-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210281-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210281-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210281-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210281-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210281-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210281-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210281-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210281-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210281-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A210281-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69367-296-30 69367029630 30 TABLET, FILM COATED in 1 BOTTLE (69367-296-30) 2020-11-22 0000-00-00 No No Current