Home NDC 58151-098 Detrol
Product NDC 58151-098
11-digit product format 581510098
Labeler code 58151
Product ID 58151-098_f27726af-7a9b-45f4-96e0-1e90a5fdcc18
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tolterodine tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Viatris Specialty LLC
Application NDA020771
Marketing category NDA
Marketing start 2024-05-21
Marketing end 2026-08-31
Substance TOLTERODINE TARTRATE
Active strength 1 mg/1
Pharmacologic classes Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag No
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 N020771-001 DETROL TOLTERODINE TARTRATE 1MG TABLET / ORAL AB RLD 1998-03-25 N020771-002 DETROL TOLTERODINE TARTRATE 2MG TABLET / ORAL AB RLD, RS 1998-03-25
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 2026-08-01 22:54:32 2026-06 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N020771-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 N020771-002 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Detrol Active Ingredients# Ingredient, Strength table Ingredient Strength TOLTERODINE TARTRATE 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5T619TQR3R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855178 Internal RxNorm lookup 855180 Internal RxNorm lookup 855194 Internal RxNorm lookup 855195 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 58151-098-91 Detrol 60 in 1 BOTTLE TABLET, FILM COATED 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58151-098 DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [VIATRIS SPECIALTY LLC] 5 Current NDC, 1 package rows 20250201_41eb00d2-64e3-4ec9-8732-4bfc81b04180.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 58151-098-91 58151009891 60 TABLET, FILM COATED in 1 BOTTLE (58151-098-91) 2024-05-21 2026-08-31 No No Historical