temozolomide

Generic: temozolomide

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

Drug Facts

Product Profile

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

temozolomide 100 mg/1

Manufacturer
Nivagen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 75834-143
Product ID 75834-143_9db23336-458a-46a6-a676-1702497a1891
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213328
Listing Expiration 2026-12-31
Marketing Start 2021-12-07

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 75834143
Hyphenated Format 75834-143

Supplemental Identifiers

RxCUI
313209 313210 313211 317160 700883 700885
UPC
0375834145051 0375834144146 0375834144054 0375834143057 0375834143149 0375834145143 0375834142142 0375834142050 0375834146058 0375834132143 0375834132051
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 ANDA213328 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (75834-143-05) / 5 CAPSULE in 1 BOTTLE
  • 1 CARTON in 1 CARTON (75834-143-14) / 14 CAPSULE in 1 CARTON
source: ndc

Packages (2)

75834-143-05 1 BOTTLE in 1 CARTON (75834-143-05) / 5 CAPSULE in 1 BOTTLE 75834-143-14 1 CARTON in 1 CARTON (75834-143-14) / 14 CAPSULE in 1 CARTON

Ingredients (1)

temozolomide (100 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": "9db23336-458a-46a6-a676-1702497a1891", "openfda": {"nui": ["N0000000236", "N0000175558"], "upc": ["0375834145051", "0375834144146", "0375834144054", "0375834143057", "0375834143149", "0375834145143", "0375834142142", "0375834142050", "0375834146058", "0375834132143", "0375834132051"], "unii": ["YF1K15M17Y"], "rxcui": ["313209", "313210", "313211", "317160", "700883", "700885"], "spl_set_id": ["27e5a781-e4f2-4489-9def-7971d0b86d9c"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Nivagen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (75834-143-05)  / 5 CAPSULE in 1 BOTTLE", "package_ndc": "75834-143-05", "marketing_start_date": "20211207"}, {"sample": false, "description": "1 CARTON in 1 CARTON (75834-143-14)  / 14 CAPSULE in 1 CARTON", "package_ndc": "75834-143-14", "marketing_start_date": "20211207"}], "brand_name": "temozolomide", "product_id": "75834-143_9db23336-458a-46a6-a676-1702497a1891", "dosage_form": "CAPSULE", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "75834-143", "generic_name": "temozolomide", "labeler_name": "Nivagen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "temozolomide", "active_ingredients": [{"name": "TEMOZOLOMIDE", "strength": "100 mg/1"}], "application_number": "ANDA213328", "marketing_category": "ANDA", "marketing_start_date": "20211207", "listing_expiration_date": "20261231"}