Home NDC 52536-342 Lomustine
Product NDC 52536-342
11-digit product format 525360342
Labeler code 52536
Product ID 52536-342_934ec2f1-8c3f-4978-b712-33e98c4295a5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lomustine
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Wilshire Pharmaceuticals, Inc.
Application NDA017588
Marketing category NDA
Marketing start 2026-04-15
Substance LOMUSTINE
Active strength 100 mg/1
Pharmacologic classes Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N017588-001 GLEOSTINE LOMUSTINE 10MG CAPSULE / ORAL AB RLD, Approved before 1982 N017588-002 GLEOSTINE LOMUSTINE 40MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 N017588-003 GLEOSTINE LOMUSTINE 100MG CAPSULE / ORAL AB RLD, Approved before 1982 N017588-004 GLEOSTINE LOMUSTINE 5MG CAPSULE / ORAL RLD 2014-12-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 N017588-001 GLEOSTINE 10MG CAPSULE / ORAL AB RLD, Approved before 1982 a50c72e98297…2026-08-01 22:54:32 2026-06 N017588-002 GLEOSTINE 40MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 a50c72e98297…2026-08-01 22:54:32 2026-06 N017588-003 GLEOSTINE 100MG CAPSULE / ORAL AB RLD, Approved before 1982 a50c72e98297…2026-08-01 22:54:32 2026-06 N017588-004 GLEOSTINE 5MG CAPSULE / ORAL RLD 2014-12-19 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lomustine LOMUSTINE Wilshire Pharmaceuticals, Inc. 3c3637fc-4499-4331-a3c4-6969fc86704e 2026-02-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 017588 application number: NDA017588 ndc (product): 52536-342 Gleostine LOMUSTINE Azurity Pharmaceuticals, Inc. 3529fe2f-3c23-4862-bb20-b48026957082 2025-09-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 017588 application number: NDA017588 Gleostine LOMUSTINE NextSource Biotechnology, LLC 7f77526b-4c40-409c-82ea-d0f934d89cc2 2024-01-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 017588 application number: NDA017588
Additional Listing Data#
Finished product Yes
Brand name base Lomustine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOMUSTINE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7BRF0Z81KG Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197894 Internal RxNorm lookup 197895 Internal RxNorm lookup 197896 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 52536-342-05 Lomustine 5 in 1 BOTTLE CAPSULE, GELATIN COATED 5 2 52536-342-05 Lomustine 1 in 1 CARTON CAPSULE, GELATIN COATED 1 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 52536-342-05 52536034205 1 BOTTLE in 1 CARTON (52536-342-05) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE 1 bottle 2026-04-15 No No Current