thiotepa

Generic: thiotepa

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

thiotepa 100 mg/1

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-029
Product ID 65219-029_a1ce70f8-1f22-4771-b51a-2e9b12876558
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214222
Listing Expiration 2026-12-31
Marketing Start 2022-04-11

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 65219029
Hyphenated Format 65219-029

Supplemental Identifiers

RxCUI
1660004
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 ANDA214222 (source: ndc)
Routes
INTRACAVITARY INTRAVENOUS INTRAVESICAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (65219-029-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
source: ndc

Packages (1)

65219-029-20 1 VIAL in 1 CARTON (65219-029-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Ingredients (1)

thiotepa (100 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": "a1ce70f8-1f22-4771-b51a-2e9b12876558", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["905Z5W3GKH"], "rxcui": ["1660004"], "spl_set_id": ["493410f3-0733-4f76-8050-6529d96f2a5b"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (65219-029-20)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "65219-029-20", "marketing_start_date": "20220411"}], "brand_name": "Thiotepa", "product_id": "65219-029_a1ce70f8-1f22-4771-b51a-2e9b12876558", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "65219-029", "generic_name": "Thiotepa", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Thiotepa", "active_ingredients": [{"name": "THIOTEPA", "strength": "100 mg/1"}], "application_number": "ANDA214222", "marketing_category": "ANDA", "marketing_start_date": "20220411", "listing_expiration_date": "20261231"}