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 43 .
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.
Product history page 1 of 2 · 43 observed 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 2026-09-14 22:38:34 2026-08 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206430-001 VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO 2019-04-19 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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.
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