SOLIFENACIN SUCCINATE

Product NDC
51407-472
11-digit product format
514070472
Labeler code
51407
Product ID
51407-472_1e062592-d7ea-5ac8-e063-6394a90aacfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SOLIFENACIN SUCCINATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA211657
Marketing category
ANDA
Marketing start
2019-05-20
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211657-001SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-20
A211657-002SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATE10MGTABLET / ORALABRS2019-05-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A211657-001AB
A211657-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211657-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211657-002SOLIFENACIN SUCCINATE10MGTABLET / ORALABRS2019-05-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211657-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211657-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A211657-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211657-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211657-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211657-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211657-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211657-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211657-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211657-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211657-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211657-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211657-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211657-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211657-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211657-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211657-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A211657-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211657-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211657-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211657-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211657-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211657-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211657-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211657-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211657-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211657-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211657-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211657-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211657-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211657-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211657-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211657-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211657-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211657-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211657-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211657-001SOLIFENACIN SUCCINATE5MGTABLET / ORALAB2019-05-20782e0a99824c…
2021-12-28 21:50 UTC2021-12A211657-002SOLIFENACIN SUCCINATE10MGTABLET / ORALAB2019-05-20782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211657-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211657-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211657-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211657-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211657-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211657-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211657-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211657-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211657-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211657-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211657-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211657-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211657-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211657-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211657-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211657-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211657-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211657-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211657-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211657-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211657-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211657-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211657-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211657-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211657-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211657-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211657-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211657-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211657-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211657-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211657-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211657-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211657-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211657-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211657-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211657-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211657-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211657-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211657-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A211657-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
SOLIFENACIN SUCCINATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOLIFENACIN SUCCINATE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KKA5DLD701Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
477367Internal RxNorm lookup
477372Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c84682ca-afca-a066-e053-2995a90a3257Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efc179d5-753a-8dcd-90d4-5676a1c31ce3Product name720250423
7a525cfb-2fd5-4f2e-bf22-13a2c0cea1ddProduct name120201030

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-472-30SOLIFENACIN SUCCINATE30 in 1 BOTTLETABLET, FILM COATED302
51407-472-90SOLIFENACIN SUCCINATE90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-472-30EA - Each51407-4723ad51978-b800-4b51-b6d2-56a0010509c912021-09-07
51407-472-90EA - Each51407-47217e3cd08-0e9d-41d6-a1d1-47c176db8f1d12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-472SOLIFENACIN SUCCINATE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2Current NDC, Legacy NDC, 2 package rows20240726_c84682ca-afca-a066-e053-2995a90a3257.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATEGolden State Medical Supply, Inc.c84682ca-afca-a066-e053-2995a90a32572024-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211657
application number: ANDA211657
ndc (product): 51407-472
SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATEBryant Ranch Prepack7eb1a5d6-4972-44f4-8ab9-80b932bf81e02024-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211657
application number: ANDA211657
SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATEBryant Ranch Prepack49346a96-3d96-4702-b96e-94e635510dba2024-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211657
application number: ANDA211657
SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATEScieGen Pharmaceuticals, Inc.a6f154d9-7463-4b80-b80e-c06a06e361412021-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211657
application number: ANDA211657

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477372solifenacin succinate 10 MG Oral TabletPSNc84682ca-afca-a066-e053-2995a90a32572
477367solifenacin succinate 5 MG Oral TabletPSNc84682ca-afca-a066-e053-2995a90a32572
477372solifenacin succinate 10 MG Oral TabletSCDc84682ca-afca-a066-e053-2995a90a32572
477367solifenacin succinate 5 MG Oral TabletSCDc84682ca-afca-a066-e053-2995a90a32572

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-472-305140704723030 TABLET, FILM COATED in 1 BOTTLE (51407-472-30) 2021-08-020000-00-00NoNoCurrent
51407-472-905140704729090 TABLET, FILM COATED in 1 BOTTLE (51407-472-90) 2021-08-020000-00-00NoNoCurrent