lomustine

Generic: lomustine

Labeler: carnegie pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lomustine
Generic Name lomustine
Labeler carnegie pharmaceuticals llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

lomustine 40 mg/1

Manufacturer
Carnegie Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 80005-115
Product ID 80005-115_42672c94-b4e6-4bb8-b6b4-7c429acd7ea2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219265
Listing Expiration 2026-12-31
Marketing Start 2025-11-10

Pharmacologic Class

Established (EPC)
alkylating drug [epc]
Mechanism of Action
alkylating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80005115
Hyphenated Format 80005-115

Supplemental Identifiers

RxCUI
197894 197895 197896
UPC
0380005116020
UNII
7BRF0Z81KG
NUI
N0000000236 N0000175558

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lomustine (source: ndc)
Generic Name lomustine (source: ndc)
Application Number ANDA219265 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 5 CAPSULE in 1 BOTTLE (80005-115-02)
source: ndc

Packages (1)

80005-115-02 5 CAPSULE in 1 BOTTLE (80005-115-02)

Ingredients (1)

lomustine (40 mg/1)

Linked Drug Pages (1)

LOMUSTINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "42672c94-b4e6-4bb8-b6b4-7c429acd7ea2", "openfda": {"nui": ["N0000000236", "N0000175558"], "upc": ["0380005116020"], "unii": ["7BRF0Z81KG"], "rxcui": ["197894", "197895", "197896"], "spl_set_id": ["916dfac8-da11-40e4-9e44-a909e29a6b5f"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Carnegie Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 CAPSULE in 1 BOTTLE (80005-115-02)", "package_ndc": "80005-115-02", "marketing_start_date": "20251110"}], "brand_name": "LOMUSTINE", "product_id": "80005-115_42672c94-b4e6-4bb8-b6b4-7c429acd7ea2", "dosage_form": "CAPSULE", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "80005-115", "generic_name": "LOMUSTINE", "labeler_name": "Carnegie Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LOMUSTINE", "active_ingredients": [{"name": "LOMUSTINE", "strength": "40 mg/1"}], "application_number": "ANDA219265", "marketing_category": "ANDA", "marketing_start_date": "20251110", "listing_expiration_date": "20261231"}