Home NDC 67979-001 Valstar
Product NDC 67979-001
11-digit product format 679790001
Labeler code 67979
Product ID 67979-001_25cb4a4a-e28a-c674-e063-6294a90a0bdd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valrubicin
Dosage form SOLUTION, CONCENTRATE
Route INTRAVESICAL
Labeler Endo USA, Inc.
Application NDA020892
Marketing category NDA
Marketing start 1998-10-01
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 N020892-001 VALSTAR PRESERVATIVE FREE VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020892-001 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 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 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 Valstar
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 262063 Internal RxNorm lookup 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 67979-001-01 Valstar 4 in 1 CARTON SOLUTION, CONCENTRATE 4 38 67979-001-01 Valstar 5 mL in 1 VIAL SOLUTION, CONCENTRATE 5 38
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67979-001 VALSTAR (VALRUBICIN) SOLUTION, CONCENTRATE [ENDO USA, INC.] 38 Current NDC, Legacy NDC, 2 package rows 20241102_e96f30a0-6662-11de-8f80-0002a5d5c51b.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 67979-001-01 67979000101 4 VIAL in 1 CARTON (67979-001-01) / 5 mL in 1 VIAL 4 vial 1998-10-01 0000-00-00 No No Current