Home NDC 24201-101 Valrubicin Intravesical Solution
Product NDC 24201-101
11-digit product format 242010101
Labeler code 24201
Product ID 24201-101_f2385edd-45ba-4ce8-97a0-ac301d067536
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valrubicin Intravesical Solution
Dosage form SOLUTION, CONCENTRATE
Route INTRAVESICAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA206430
Marketing category ANDA
Marketing start 2019-04-23
Substance VALRUBICIN
Active strength 40 mg/mL
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206430-001 VALRUBICIN VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206430-001 AO
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 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 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 A206430-001 AO 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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Valrubicin Intravesical Solution
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALRUBICIN 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2C6NUM6878 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313567 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 24201-101-04 Valrubicin Intravesical Solution 4 in 1 CARTON SOLUTION, CONCENTRATE 4 2 24201-101-04 Valrubicin Intravesical Solution 5 mL in 1 VIAL SOLUTION, CONCENTRATE 5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24201-101 VALRUBICIN INTRAVESICAL SOLUTION SOLUTION, CONCENTRATE [HIKMA PHARMACEUTICALS USA INC.] 2 Current NDC, Legacy NDC, 2 package rows 20221110_8739ae02-e4c5-0fa2-e053-2a91aa0a1b74.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 24201-101-04 24201010104 4 VIAL in 1 CARTON (24201-101-04) / 5 mL in 1 VIAL 4 vial 2019-04-23 0000-00-00 No No Current