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 CAPSULE
Routes
ORAL
Active Ingredients

temozolomide 5 mg/1

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0085-3004
Product ID 0085-3004_40ceddc0-83a2-4b3b-8953-fd0078a41133
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021029
Listing Expiration 2027-12-31
Marketing Start 1999-08-11

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 00853004
Hyphenated Format 0085-3004

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 NDA021029 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 5 PACKET in 1 CARTON (0085-3004-03) / 1 CAPSULE in 1 PACKET (0085-3004-05)
  • 14 PACKET in 1 CARTON (0085-3004-04) / 1 CAPSULE in 1 PACKET (0085-3004-05)
source: ndc

Packages (2)

0085-3004-03 5 PACKET in 1 CARTON (0085-3004-03) / 1 CAPSULE in 1 PACKET (0085-3004-05) 0085-3004-04 14 PACKET in 1 CARTON (0085-3004-04) / 1 CAPSULE in 1 PACKET (0085-3004-05)

Ingredients (1)

temozolomide (5 mg/1)

Linked Drug Pages (1)

TEMODAR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "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": "5 PACKET in 1 CARTON (0085-3004-03)  / 1 CAPSULE in 1 PACKET (0085-3004-05)", "package_ndc": "0085-3004-03", "marketing_start_date": "19990811"}, {"sample": false, "description": "14 PACKET in 1 CARTON (0085-3004-04)  / 1 CAPSULE in 1 PACKET (0085-3004-05)", "package_ndc": "0085-3004-04", "marketing_start_date": "19990811"}], "brand_name": "TEMODAR", "product_id": "0085-3004_40ceddc0-83a2-4b3b-8953-fd0078a41133", "dosage_form": "CAPSULE", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "0085-3004", "generic_name": "Temozolomide", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TEMODAR", "active_ingredients": [{"name": "TEMOZOLOMIDE", "strength": "5 mg/1"}], "application_number": "NDA021029", "marketing_category": "NDA", "marketing_start_date": "19990811", "listing_expiration_date": "20271231"}