thiotepa

Generic: thiotepa

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

Drug Facts

Product Profile

Brand Name thiotepa
Generic Name thiotepa
Labeler novadoz pharmaceuticals llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRACAVITARY INTRAVENOUS INTRAVESICAL
Active Ingredients

thiotepa 15 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-045
Product ID 72205-045_fa8d1c84-357b-433d-8f78-89175c9a8cbc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213049
Listing Expiration 2026-12-31
Marketing Start 2020-02-01

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 72205045
Hyphenated Format 72205-045

Supplemental Identifiers

RxCUI
1660004 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 ANDA213049 (source: ndc)
Routes
INTRACAVITARY INTRAVENOUS INTRAVESICAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 BOX (72205-045-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
source: ndc

Packages (1)

72205-045-01 1 VIAL, GLASS in 1 BOX (72205-045-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS

Ingredients (1)

thiotepa (15 mg/1)

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": "fa8d1c84-357b-433d-8f78-89175c9a8cbc", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["905Z5W3GKH"], "rxcui": ["1660004", "1660009"], "spl_set_id": ["b702dcc9-dd0e-4386-b1e2-f20562fd2ad9"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 BOX (72205-045-01)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS", "package_ndc": "72205-045-01", "marketing_start_date": "20200201"}], "brand_name": "Thiotepa", "product_id": "72205-045_fa8d1c84-357b-433d-8f78-89175c9a8cbc", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "72205-045", "generic_name": "Thiotepa", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Thiotepa", "active_ingredients": [{"name": "THIOTEPA", "strength": "15 mg/1"}], "application_number": "ANDA213049", "marketing_category": "ANDA", "marketing_start_date": "20200201", "listing_expiration_date": "20261231"}