temozolomide

Generic: temozolomide

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name temozolomide
Generic Name temozolomide
Labeler amneal pharmaceuticals llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

temozolomide 5 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-801
Product ID 65162-801_7cf62d84-45c0-405c-975b-3dbcbcf5ee27
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203691
Listing Expiration 2026-12-31
Marketing Start 2015-04-03

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 65162801
Hyphenated Format 65162-801

Supplemental Identifiers

RxCUI
313209 313210 313211 317160 700883 700885
UPC
0365162803518 0365162802511 0365162805512 0365162804515 0365162806519 0365162801514
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 ANDA203691 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (65162-801-14) / 14 CAPSULE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (65162-801-51) / 5 CAPSULE in 1 BOTTLE
source: ndc

Packages (2)

65162-801-14 1 BOTTLE in 1 CARTON (65162-801-14) / 14 CAPSULE in 1 BOTTLE 65162-801-51 1 BOTTLE in 1 CARTON (65162-801-51) / 5 CAPSULE in 1 BOTTLE

Ingredients (1)

temozolomide (5 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": "7cf62d84-45c0-405c-975b-3dbcbcf5ee27", "openfda": {"nui": ["N0000000236", "N0000175558"], "upc": ["0365162803518", "0365162802511", "0365162805512", "0365162804515", "0365162806519", "0365162801514"], "unii": ["YF1K15M17Y"], "rxcui": ["313209", "313210", "313211", "317160", "700883", "700885"], "spl_set_id": ["6c8529ec-8936-4fec-a1a5-2b285c7e4859"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65162-801-14)  / 14 CAPSULE in 1 BOTTLE", "package_ndc": "65162-801-14", "marketing_start_date": "20150403"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (65162-801-51)  / 5 CAPSULE in 1 BOTTLE", "package_ndc": "65162-801-51", "marketing_start_date": "20150403"}], "brand_name": "Temozolomide", "product_id": "65162-801_7cf62d84-45c0-405c-975b-3dbcbcf5ee27", "dosage_form": "CAPSULE", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "65162-801", "generic_name": "Temozolomide", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Temozolomide", "active_ingredients": [{"name": "TEMOZOLOMIDE", "strength": "5 mg/1"}], "application_number": "ANDA203691", "marketing_category": "ANDA", "marketing_start_date": "20150403", "listing_expiration_date": "20261231"}