Home NDC 69539-050 Solifenacin Succinate
Product NDC 69539-050
11-digit product format 695390050
Labeler code 69539
Product ID 69539-050_e4d7d9f6-481e-4029-9b0d-74c291550367
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Solifenacin Succinate
Dosage form TABLET
Route ORAL
Labeler MSN LABORATORIES PRIVATE LIMITED
Application ANDA210688
Marketing category ANDA
Marketing start 2019-05-20
Marketing end 0000-00-00
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 2022-12-31
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 69539-050-82 excluded package package 69539-050-81 excluded package package 69539-050-83
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 A210688-001 SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 A210688-002 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 A210688-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210688-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210688-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210688-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210688-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210688-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210688-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210688-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210688-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210688-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210688-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210688-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210688-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210688-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210688-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210688-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210688-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210688-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210688-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210688-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210688-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210688-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210688-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210688-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210688-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210688-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210688-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210688-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210688-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210688-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210688-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210688-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210688-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210688-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210688-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210688-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210688-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210688-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-05-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210688-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-05-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A210688-002 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.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69539-050 SOLIFENACIN SUCCINATE TABLET [MSN LABORATORIES PRIVATE LIMITED] 8 Legacy NDC 20210714_803c073a-eebc-4bee-b7e1-456bc7558afc.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69539-050-30 69539005030 30 TABLET in 1 BOTTLE (69539-050-30) 30 tablet 2019-05-20 0000-00-00 No No Current 69539-050-81 69539005081 30 TABLET in 1 BOTTLE (69539-050-81) 30 tablet 2019-05-20 0000-00-00 No No Current 69539-050-82 69539005082 90 TABLET in 1 BOTTLE (69539-050-82) 90 tablet 2019-05-20 0000-00-00 No No Current 69539-050-83 69539005083 1000 TABLET in 1 BOTTLE (69539-050-83) 1000 tablet 2019-05-20 0000-00-00 No No Current 69539-050-90 69539005090 90 TABLET in 1 BOTTLE (69539-050-90) 90 tablet 2019-05-20 0000-00-00 No No Current 69539-050-99 69539005099 1000 TABLET in 1 BOTTLE (69539-050-99) 1000 tablet 2019-05-20 0000-00-00 No No Current