temodar

Generic: temozolomide

Labeler: merck sharp & dohme llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name temodar
Generic Name temozolomide
Labeler merck sharp & dohme llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

temozolomide 2.5 mg/mL

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0085-1381
Product ID 0085-1381_40ceddc0-83a2-4b3b-8953-fd0078a41133
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022277
Listing Expiration 2027-12-31
Marketing Start 2009-02-27

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 00851381
Hyphenated Format 0085-1381

Supplemental Identifiers

RxCUI
261288 261289 261290 261291 313209 313210 313211 317160 700883 700885 705617 705619 835945 835948
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 temodar (source: ndc)
Generic Name temozolomide (source: ndc)
Application Number NDA022277 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (0085-1381-01) / 40 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

0085-1381-01 1 VIAL, SINGLE-USE in 1 CARTON (0085-1381-01) / 40 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

temozolomide (2.5 mg/mL)

Linked Drug Pages (1)

TEMODAR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "40ceddc0-83a2-4b3b-8953-fd0078a41133", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["YF1K15M17Y"], "rxcui": ["261288", "261289", "261290", "261291", "313209", "313210", "313211", "317160", "700883", "700885", "705617", "705619", "835945", "835948"], "spl_set_id": ["046a9011-3911-4d3f-a15f-fbb56d5aad56"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (0085-1381-01)  / 40 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0085-1381-01", "marketing_start_date": "20090227"}], "brand_name": "TEMODAR", "product_id": "0085-1381_40ceddc0-83a2-4b3b-8953-fd0078a41133", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "0085-1381", "generic_name": "Temozolomide", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TEMODAR", "active_ingredients": [{"name": "TEMOZOLOMIDE", "strength": "2.5 mg/mL"}], "application_number": "NDA022277", "marketing_category": "NDA", "marketing_start_date": "20090227", "listing_expiration_date": "20271231"}