temozolomide

Generic: temozolomide

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

Drug Facts

Product Profile

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

temozolomide 250 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-416
Product ID 31722-416_24d38de8-4acf-bdac-e063-6394a90ad431
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210030
Listing Expiration 2026-12-31
Marketing Start 2024-08-23

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 31722416
Hyphenated Format 31722-416

Supplemental Identifiers

RxCUI
313209 313210 313211 317160 700883 700885
UPC
0331722415316 0331722414319 0331722413312 0331722411318 0331722412315 0331722416313
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 ANDA210030 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 14 CAPSULE in 1 BOTTLE (31722-416-14)
  • 5 CAPSULE in 1 BOTTLE (31722-416-31)
source: ndc

Packages (2)

31722-416-14 14 CAPSULE in 1 BOTTLE (31722-416-14) 31722-416-31 5 CAPSULE in 1 BOTTLE (31722-416-31)

Ingredients (1)

temozolomide (250 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": "24d38de8-4acf-bdac-e063-6394a90ad431", "openfda": {"nui": ["N0000000236", "N0000175558"], "upc": ["0331722415316", "0331722414319", "0331722413312", "0331722411318", "0331722412315", "0331722416313"], "unii": ["YF1K15M17Y"], "rxcui": ["313209", "313210", "313211", "317160", "700883", "700885"], "spl_set_id": ["78c12889-c837-40c1-8f85-4d048008ad29"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 CAPSULE in 1 BOTTLE (31722-416-14)", "package_ndc": "31722-416-14", "marketing_start_date": "20240823"}, {"sample": false, "description": "5 CAPSULE in 1 BOTTLE (31722-416-31)", "package_ndc": "31722-416-31", "marketing_start_date": "20240823"}], "brand_name": "TEMOZOLOMIDE", "product_id": "31722-416_24d38de8-4acf-bdac-e063-6394a90ad431", "dosage_form": "CAPSULE", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "31722-416", "generic_name": "TEMOZOLOMIDE", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TEMOZOLOMIDE", "active_ingredients": [{"name": "TEMOZOLOMIDE", "strength": "250 mg/1"}], "application_number": "ANDA210030", "marketing_category": "ANDA", "marketing_start_date": "20240823", "listing_expiration_date": "20261231"}