thiotepa

Generic: thiotepa

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name thiotepa
Generic Name thiotepa
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRACAVITARY INTRAVENOUS INTRAVESICAL
Active Ingredients

thiotepa 15 mg/1.5mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9309
Product ID 0143-9309_43ac39a1-a0e0-48e9-93e2-e7e754bc6038
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075547
Listing Expiration 2026-12-31
Marketing Start 2001-06-01

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 01439309
Hyphenated Format 0143-9309

Supplemental Identifiers

RxCUI
1660009
UNII
905Z5W3GKH
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 thiotepa (source: ndc)
Generic Name thiotepa (source: ndc)
Application Number ANDA075547 (source: ndc)
Routes
INTRACAVITARY INTRAVENOUS INTRAVESICAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1.5mL
source: ndc
Packaging
  • 1 VIAL in 1 BOX, UNIT-DOSE (0143-9309-01) / 1.5 mL in 1 VIAL
source: ndc

Packages (1)

0143-9309-01 1 VIAL in 1 BOX, UNIT-DOSE (0143-9309-01) / 1.5 mL in 1 VIAL

Ingredients (1)

thiotepa (15 mg/1.5mL)

Linked Drug Pages (1)

Thiotepa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRACAVITARY", "INTRAVENOUS", "INTRAVESICAL"], "spl_id": "43ac39a1-a0e0-48e9-93e2-e7e754bc6038", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["905Z5W3GKH"], "rxcui": ["1660009"], "spl_set_id": ["6dc898dc-5949-4aa4-83f8-4bd20c29eb93"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX, UNIT-DOSE (0143-9309-01)  / 1.5 mL in 1 VIAL", "package_ndc": "0143-9309-01", "marketing_start_date": "20010601"}], "brand_name": "Thiotepa", "product_id": "0143-9309_43ac39a1-a0e0-48e9-93e2-e7e754bc6038", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "0143-9309", "generic_name": "Thiotepa", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Thiotepa", "active_ingredients": [{"name": "THIOTEPA", "strength": "15 mg/1.5mL"}], "application_number": "ANDA075547", "marketing_category": "ANDA", "marketing_start_date": "20010601", "listing_expiration_date": "20261231"}