temozolomide

Generic: temozolomide

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name temozolomide
Generic Name temozolomide
Labeler rising pharma holdings, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

temozolomide 20 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-817
Product ID 16571-817_b75f958e-33bc-434d-a4ae-e5fa9d6f4ab5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206309
Listing Expiration 2026-12-31
Marketing Start 2022-10-04

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 16571817
Hyphenated Format 16571-817

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 ANDA206309 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 20 CAPSULE in 1 BOTTLE (16571-817-02)
  • 14 CAPSULE in 1 BOTTLE (16571-817-41)
  • 5 CAPSULE in 1 BOTTLE (16571-817-51)
source: ndc

Packages (3)

16571-817-02 20 CAPSULE in 1 BOTTLE (16571-817-02) 16571-817-41 14 CAPSULE in 1 BOTTLE (16571-817-41) 16571-817-51 5 CAPSULE in 1 BOTTLE (16571-817-51)

Ingredients (1)

temozolomide (20 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": "b75f958e-33bc-434d-a4ae-e5fa9d6f4ab5", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["YF1K15M17Y"], "rxcui": ["313209", "313210", "313211", "317160", "700883", "700885"], "spl_set_id": ["70996a9d-4a4f-4ed1-ab07-130486aa14ab"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 CAPSULE in 1 BOTTLE (16571-817-02)", "package_ndc": "16571-817-02", "marketing_start_date": "20221004"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (16571-817-41)", "package_ndc": "16571-817-41", "marketing_start_date": "20221004"}, {"sample": false, "description": "5 CAPSULE in 1 BOTTLE (16571-817-51)", "package_ndc": "16571-817-51", "marketing_start_date": "20221004"}], "brand_name": "TEMOZOLOMIDE", "product_id": "16571-817_b75f958e-33bc-434d-a4ae-e5fa9d6f4ab5", "dosage_form": "CAPSULE", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "16571-817", "generic_name": "temozolomide", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TEMOZOLOMIDE", "active_ingredients": [{"name": "TEMOZOLOMIDE", "strength": "20 mg/1"}], "application_number": "ANDA206309", "marketing_category": "ANDA", "marketing_start_date": "20221004", "listing_expiration_date": "20261231"}