Home NDC 80005-116 LOMUSTINE
Product NDC 80005-116
11-digit product format 800050116
Labeler code 80005
Product ID 80005-116_42672c94-b4e6-4bb8-b6b4-7c429acd7ea2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LOMUSTINE
Dosage form CAPSULE
Route ORAL
Labeler Carnegie Pharmaceuticals LLC
Application ANDA219265
Marketing category ANDA
Marketing start 2025-11-10
Substance LOMUSTINE
Active strength 100 mg/1
Pharmacologic classes Alkylating Activity [MoA], Alkylating Drug [EPC]
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219265-001 LOMUSTINE LOMUSTINE 10MG CAPSULE / ORAL AB 2025-10-27 A219265-002 LOMUSTINE LOMUSTINE 40MG CAPSULE / ORAL AB 2025-10-27 A219265-003 LOMUSTINE LOMUSTINE 100MG CAPSULE / ORAL AB 2025-10-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A219265-001 CGT 2026-05-19 A219265-002 CGT 2026-05-19 A219265-003 CGT 2026-05-19
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 2026-02-19 14:30 UTC 2026-02 A219265-001 LOMUSTINE 10MG CAPSULE / ORAL AB 2025-10-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219265-002 LOMUSTINE 40MG CAPSULE / ORAL AB 2025-10-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219265-003 LOMUSTINE 100MG CAPSULE / ORAL AB 2025-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219265-001 LOMUSTINE 10MG CAPSULE / ORAL AB 2025-10-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219265-002 LOMUSTINE 40MG CAPSULE / ORAL AB 2025-10-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219265-003 LOMUSTINE 100MG CAPSULE / ORAL AB 2025-10-27 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219265-001 LOMUSTINE 10MG CAPSULE / ORAL AB 2025-10-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219265-002 LOMUSTINE 40MG CAPSULE / ORAL AB 2025-10-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219265-003 LOMUSTINE 100MG CAPSULE / ORAL AB 2025-10-27 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219265-001 CGT 2026-05-19 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219265-002 CGT 2026-05-19 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219265-003 CGT 2026-05-19 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base LOMUSTINE
Listing expiration 2026-12-31 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 80005-116-02 LOMUSTINE 5 in 1 BOTTLE CAPSULE 5 1
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 Sample Exclude flag Status 80005-116-02 80005011602 5 CAPSULE in 1 BOTTLE (80005-116-02) 5 capsule 2025-11-10 No No Current