Home NDC 72205-020 Solifenacin Succinate
Product NDC 72205-020
11-digit product format 722050020
Labeler code 72205
Product ID 72205-020_eaccb7fc-2098-43d1-a64e-759b8d4c35c2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Solifenacin Succinate
Dosage form TABLET
Route ORAL
Labeler Novadoz Pharmaceuticals LLC
Application ANDA210688
Marketing category ANDA
Marketing start 2019-05-20
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 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.
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 72205-020-30 Solifenacin Succinate 30 in 1 BOTTLE TABLET 30 3 72205-020-90 Solifenacin Succinate 90 in 1 BOTTLE TABLET 90 3 72205-020-99 Solifenacin Succinate 1000 in 1 BOTTLE TABLET 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72205-020 SOLIFENACIN SUCCINATE TABLET [NOVADOZ PHARMACEUTICALS LLC] 3 Current NDC, Legacy NDC, 3 package rows 20210715_98b99a4c-201d-46ee-b78c-7634a64d3a8d.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 72205-020-30 72205002030 30 TABLET in 1 BOTTLE (72205-020-30) 30 tablet 2019-05-20 0000-00-00 No No Current 72205-020-90 72205002090 90 TABLET in 1 BOTTLE (72205-020-90) 90 tablet 2019-05-20 0000-00-00 No No Current 72205-020-99 72205002099 1000 TABLET in 1 BOTTLE (72205-020-99) 1000 tablet 2019-05-20 0000-00-00 No No Current