temozolomide

Generic: temozolomide

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name temozolomide
Generic Name temozolomide
Labeler accord healthcare inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

temozolomide 5 mg/1

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-048
Product ID 16729-048_35ce99f0-8af9-4660-e063-6294a90a54bf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201528
Listing Expiration 2026-12-31
Marketing Start 2017-03-07

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 16729048
Hyphenated Format 16729-048

Supplemental Identifiers

RxCUI
313209 313210 313211 317160 700883 700885
UPC
0316729051316 0319729048317 0316729050319 0316729049535 0316729129534 0316729130318 0316729129312 0316729051538 0316729049313 0316729050531
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 ANDA201528 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (16729-048-53) / 5 CAPSULE in 1 BOTTLE, GLASS
  • 1 BOTTLE, GLASS in 1 CARTON (16729-048-54) / 14 CAPSULE in 1 BOTTLE, GLASS
source: ndc

Packages (2)

16729-048-53 1 BOTTLE, GLASS in 1 CARTON (16729-048-53) / 5 CAPSULE in 1 BOTTLE, GLASS 16729-048-54 1 BOTTLE, GLASS in 1 CARTON (16729-048-54) / 14 CAPSULE in 1 BOTTLE, GLASS

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": "35ce99f0-8af9-4660-e063-6294a90a54bf", "openfda": {"nui": ["N0000000236", "N0000175558"], "upc": ["0316729051316", "0319729048317", "0316729050319", "0316729049535", "0316729129534", "0316729130318", "0316729129312", "0316729051538", "0316729049313", "0316729050531"], "unii": ["YF1K15M17Y"], "rxcui": ["313209", "313210", "313211", "317160", "700883", "700885"], "spl_set_id": ["2d599ccf-8e63-4ff1-aa52-4809744ea97a"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (16729-048-53)  / 5 CAPSULE in 1 BOTTLE, GLASS", "package_ndc": "16729-048-53", "marketing_start_date": "20170307"}, {"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (16729-048-54)  / 14 CAPSULE in 1 BOTTLE, GLASS", "package_ndc": "16729-048-54", "marketing_start_date": "20170307"}], "brand_name": "Temozolomide", "product_id": "16729-048_35ce99f0-8af9-4660-e063-6294a90a54bf", "dosage_form": "CAPSULE", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "16729-048", "generic_name": "Temozolomide", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Temozolomide", "active_ingredients": [{"name": "TEMOZOLOMIDE", "strength": "5 mg/1"}], "application_number": "ANDA201528", "marketing_category": "ANDA", "marketing_start_date": "20170307", "listing_expiration_date": "20261231"}