Trospium Chloride

Product NDC
90096-141
11-digit product format
900960141
Labeler code
90096
Product ID
90096-141_415ee086-d26e-4e82-a350-036f5f879256
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trospium Chloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zameer Pharmaceuticals LLC
Application
ANDA215781
Marketing category
ANDA
Marketing start
2022-12-03
Substance
TROSPIUM CHLORIDE
Active strength
20 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215781-001TROSPIUM CHLORIDETROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215781-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-164b0b4de00fa7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-16cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215781-001TROSPIUM CHLORIDE20MGTABLET / ORALAB2022-02-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A215781-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215781-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215781-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215781-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215781-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215781-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215781-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215781-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215781-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215781-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215781-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215781-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215781-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215781-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215781-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215781-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215781-001AB14b0b4de00fa7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215781-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215781-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215781-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215781-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215781-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215781-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215781-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A215781-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A215781-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A215781-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A215781-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A215781-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A215781-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215781-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Trospium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TROSPIUM CHLORIDE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1E6682427EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
857560Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
048b4bc7-c77e-40fc-9bfb-bb35c6a3f871Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bfc41181-d174-476d-8a52-4a385ae9213dProduct name120250423
7c473500-2ad1-88f9-e10e-6f8136eda28cProduct name420250226
9151f483-8353-9cd4-427d-86fb1b5ba7eaProduct name420211027

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
90096-141-60Trospium Chloride60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
90096-141-60EA - Each90096-141688ab8a1-62c2-4d78-88c9-5aa58d55460412024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
90096-141TROSPIUM CHLORIDE TABLET, FILM COATED [ZAMEER PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 1 package rows20241224_048b4bc7-c77e-40fc-9bfb-bb35c6a3f871.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trospium ChlorideTROSPIUM CHLORIDEZameer Pharmaceuticals LLC048b4bc7-c77e-40fc-9bfb-bb35c6a3f8712024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215781
application number: ANDA215781
ndc (product): 90096-141

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857560trospium chloride 20 MG Oral TabletPSN048b4bc7-c77e-40fc-9bfb-bb35c6a3f8713
857560trospium chloride 20 MG Oral TabletSCD048b4bc7-c77e-40fc-9bfb-bb35c6a3f8713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
90096-141-609009601416060 TABLET, FILM COATED in 1 BOTTLE (90096-141-60) 2022-12-030000-00-00NoNoCurrent