Home NDC 33342-149 solifenacin succinate
Product NDC 33342-149
11-digit product format 333420149
Labeler code 33342
Product ID 33342-149_fbd6e753-1ed2-418a-8667-c674b215eabb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name solifenacin succinate
Dosage form TABLET, COATED
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA204374
Marketing category ANDA
Marketing start 2024-02-20
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 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 A204374-001 SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2024-02-20 A204374-002 SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2024-02-20
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.
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 A204374-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2024-02-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204374-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2024-02-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204374-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2024-02-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204374-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2024-02-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204374-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2024-02-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204374-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2024-02-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204374-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2024-02-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204374-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2024-02-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204374-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2024-02-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204374-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2024-02-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204374-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2024-02-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204374-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2024-02-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204374-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2024-02-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204374-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2024-02-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204374-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2024-02-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204374-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2024-02-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204374-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2024-02-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204374-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2024-02-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204374-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2024-02-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204374-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2024-02-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204374-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2024-02-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204374-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2024-02-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204374-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2024-02-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204374-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2024-02-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204374-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2024-02-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204374-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2024-02-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204374-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2024-02-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204374-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2024-02-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204374-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2024-02-20 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204374-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2024-02-20 6a51e52b5d6a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204374-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2024-02-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204374-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2024-02-20 a50c72e98297…
Observed Orange Book normalized TE history# 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 10 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 33342-149-07 solifenacin succinate 30 in 1 CONTAINER TABLET, COATED 30 1 33342-149-10 solifenacin succinate 90 in 1 CONTAINER TABLET, COATED 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-149 SOLIFENACIN SUCCINATE TABLET, COATED [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, 2 package rows 20240308_fbd6e753-1ed2-418a-8667-c674b215eabb.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 Marketing start Sample Exclude flag Status 33342-149-07 33342014907 30 TABLET, COATED in 1 CONTAINER (33342-149-07) 2024-02-20 No No Current 33342-149-10 33342014910 90 TABLET, COATED in 1 CONTAINER (33342-149-10) 2024-02-20 No No Current