temozolomide

Generic: temozolomide

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name temozolomide
Generic Name temozolomide
Labeler sun pharmaceutical industries, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

temozolomide 20 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-891
Product ID 47335-891_7c774570-443b-40da-8038-7cb550f92048
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201742
Listing Expiration 2026-12-31
Marketing Start 2014-02-13

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 47335891
Hyphenated Format 47335-891

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 ANDA201742 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (47335-891-21) / 14 CAPSULE in 1 BOTTLE
  • 15 BLISTER PACK in 1 CARTON (47335-891-72) / 1 CAPSULE in 1 BLISTER PACK
  • 5 BLISTER PACK in 1 CARTON (47335-891-74) / 1 CAPSULE in 1 BLISTER PACK
  • 20 BLISTER PACK in 1 CARTON (47335-891-75) / 1 CAPSULE in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (47335-891-80) / 5 CAPSULE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (47335-891-87) / 20 CAPSULE in 1 BOTTLE
source: ndc

Packages (6)

47335-891-21 1 BOTTLE in 1 CARTON (47335-891-21) / 14 CAPSULE in 1 BOTTLE 47335-891-72 15 BLISTER PACK in 1 CARTON (47335-891-72) / 1 CAPSULE in 1 BLISTER PACK 47335-891-74 5 BLISTER PACK in 1 CARTON (47335-891-74) / 1 CAPSULE in 1 BLISTER PACK 47335-891-75 20 BLISTER PACK in 1 CARTON (47335-891-75) / 1 CAPSULE in 1 BLISTER PACK 47335-891-80 1 BOTTLE in 1 CARTON (47335-891-80) / 5 CAPSULE in 1 BOTTLE 47335-891-87 1 BOTTLE in 1 CARTON (47335-891-87) / 20 CAPSULE in 1 BOTTLE

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": "7c774570-443b-40da-8038-7cb550f92048", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["YF1K15M17Y"], "rxcui": ["313209", "313210", "313211", "317160", "700883", "700885"], "spl_set_id": ["c1e05c21-a411-4493-80de-ede373632475"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (47335-891-21)  / 14 CAPSULE in 1 BOTTLE", "package_ndc": "47335-891-21", "marketing_start_date": "20140213"}, {"sample": false, "description": "15 BLISTER PACK in 1 CARTON (47335-891-72)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "47335-891-72", "marketing_start_date": "20140213"}, {"sample": false, "description": "5 BLISTER PACK in 1 CARTON (47335-891-74)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "47335-891-74", "marketing_start_date": "20140213"}, {"sample": false, "description": "20 BLISTER PACK in 1 CARTON (47335-891-75)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "47335-891-75", "marketing_start_date": "20140213"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (47335-891-80)  / 5 CAPSULE in 1 BOTTLE", "package_ndc": "47335-891-80", "marketing_start_date": "20140213"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (47335-891-87)  / 20 CAPSULE in 1 BOTTLE", "package_ndc": "47335-891-87", "marketing_start_date": "20140213"}], "brand_name": "Temozolomide", "product_id": "47335-891_7c774570-443b-40da-8038-7cb550f92048", "dosage_form": "CAPSULE", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "47335-891", "generic_name": "Temozolomide", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Temozolomide", "active_ingredients": [{"name": "TEMOZOLOMIDE", "strength": "20 mg/1"}], "application_number": "ANDA201742", "marketing_category": "ANDA", "marketing_start_date": "20140213", "listing_expiration_date": "20261231"}