Home NDC 31722-033 FESOTERODINE FUMARATE
Product NDC 31722-033
11-digit product format 317220033
Labeler code 31722
Product ID 31722-033_2f836bf8-7034-db2e-e063-6394a90a3a3e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FESOTERODINE FUMARATE
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA204792
Marketing category ANDA
Marketing start 2024-01-09
Substance FESOTERODINE FUMARATE
Active strength 4 mg/1
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 A204792-001 FESOTERODINE FUMARATE FESOTERODINE FUMARATE 4MG TABLET, EXTENDED RELEASE / ORAL AB 2024-01-09 A204792-002 FESOTERODINE FUMARATE FESOTERODINE FUMARATE 8MG TABLET, EXTENDED RELEASE / ORAL AB 2024-01-09
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 A204792-001 FESOTERODINE FUMARATE 4MG TABLET, EXTENDED RELEASE / ORAL AB 2024-01-09 a50c72e98297…2026-08-01 22:54:32 2026-06 A204792-002 FESOTERODINE FUMARATE 8MG TABLET, EXTENDED RELEASE / ORAL AB 2024-01-09 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 A204792-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A204792-002 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 FESOTERODINE FUMARATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FESOTERODINE FUMARATE 4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EOS72165S7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 810071 Internal RxNorm lookup 810077 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 31722-033-30 FESOTERODINE FUMARATE 30 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 30 2 31722-033-90 FESOTERODINE FUMARATE 90 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-033 FESOTERODINE FUMARATE (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.] 2 Current NDC, 2 package rows 20250306_dc532c6c-ff0d-488a-8a92-b1b0f37c944e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 31722-033-30 31722003330 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-033-30) 2024-01-09 No No Current 31722-033-90 31722003390 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-033-90) 2024-01-09 No No Current