Home NDC 67979-001-01 Valstar
Product NDC 67979-001
Requested package NDC 67979-001-01
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 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 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.
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 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 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 N020892-001 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 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
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