Home NDC 72303-0832-2 Solifenacin succinate
Product NDC 72303-0832
Requested package NDC 72303-0832-2
11-digit product format 723030832
Labeler code 72303
Product ID 72303-0832_55fc3fe5-e340-3480-e063-6394a90a1092
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name solifenacin succinate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler HEC Pharm USA Inc.
Application ANDA213346
Marketing category ANDA
Marketing start 2026-07-01
Substance SOLIFENACIN SUCCINATE
Active strength 10 mg/1
Pharmacologic classes Cholinergic Muscarinic Antagonist [EPC]; Cholinergic Muscarinic Antagonists [MoA]
Listing certified through 2027-12-31
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 A213346-001 SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2020-04-13 A213346-002 SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2020-04-13
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 · 74 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 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 87673890dc5c…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2020-11-12 02:37 UTC 2020-11 A213346-001 AB 1 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A213346-002 AB 1 c0c555d07b60…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213346-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213346-002 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Solifenacin succinate
Listing expiration 2027-12-31 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.
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 Marketing start Sample Status 72303-0832-2 72303083202 90 TABLET, FILM COATED in 1 BOTTLE (72303-0832-2) 2026-07-01 0 Current