temozolomide

Generic: temozolomide

Labeler: devatis, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name temozolomide
Generic Name temozolomide
Labeler devatis, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

temozolomide 5 mg/1

Manufacturer
Devatis, Inc.

Identifiers & Regulatory

Product NDC 73043-011
Product ID 73043-011_d6ae8576-1b18-45d5-b651-cc290d979032
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207658
Listing Expiration 2026-12-31
Marketing Start 2017-04-28

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 73043011
Hyphenated Format 73043-011

Supplemental Identifiers

RxCUI
313209 313210 313211 317160 700883 700885
UNII
YF1K15M17Y
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 temozolomide (source: ndc)
Generic Name temozolomide (source: ndc)
Application Number ANDA207658 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 5 CAPSULE in 1 BOTTLE (73043-011-05)
  • 14 CAPSULE in 1 BOTTLE (73043-011-14)
source: ndc

Packages (2)

73043-011-05 5 CAPSULE in 1 BOTTLE (73043-011-05) 73043-011-14 14 CAPSULE in 1 BOTTLE (73043-011-14)

Ingredients (1)

temozolomide (5 mg/1)

Linked Drug Pages (1)

Temozolomide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d6ae8576-1b18-45d5-b651-cc290d979032", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["YF1K15M17Y"], "rxcui": ["313209", "313210", "313211", "317160", "700883", "700885"], "spl_set_id": ["6b263fe0-5f06-4889-bf14-4aa185470810"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Devatis, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 CAPSULE in 1 BOTTLE (73043-011-05)", "package_ndc": "73043-011-05", "marketing_start_date": "20250401"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (73043-011-14)", "package_ndc": "73043-011-14", "marketing_start_date": "20250401"}], "brand_name": "Temozolomide", "product_id": "73043-011_d6ae8576-1b18-45d5-b651-cc290d979032", "dosage_form": "CAPSULE", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "73043-011", "generic_name": "Temozolomide", "labeler_name": "Devatis, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Temozolomide", "active_ingredients": [{"name": "TEMOZOLOMIDE", "strength": "5 mg/1"}], "application_number": "ANDA207658", "marketing_category": "ANDA", "marketing_start_date": "20170428", "listing_expiration_date": "20261231"}