tepadina

Generic: thiotepa

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

thiotepa 200 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 70121-2749
Product ID 70121-2749_4f44c872-f02d-48cc-b2a4-4e05d2422b72
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208264
Listing Expiration 2027-12-31
Marketing Start 2025-04-18

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 701212749
Hyphenated Format 70121-2749

Supplemental Identifiers

RxCUI
1660004 1660009 1919209 1919211 2712232 2712234 2734124 2734126
UPC
0370121163015 0370121163114 0370121168713 0370121274919
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 tepadina (source: ndc)
Generic Name thiotepa (source: ndc)
Application Number NDA208264 (source: ndc)
Routes
INTRACAVITARY INTRAVENOUS INTRAVESICAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BOX (70121-2749-1)
source: ndc

Packages (1)

70121-2749-1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BOX (70121-2749-1)

Ingredients (1)

thiotepa (200 mg/1)

Linked Drug Pages (1)

TEPADINA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRACAVITARY", "INTRAVENOUS", "INTRAVESICAL"], "spl_id": "4f44c872-f02d-48cc-b2a4-4e05d2422b72", "openfda": {"nui": ["N0000000236", "N0000175558"], "upc": ["0370121163015", "0370121163114", "0370121168713", "0370121274919"], "unii": ["905Z5W3GKH"], "rxcui": ["1660004", "1660009", "1919209", "1919211", "2712232", "2712234", "2734124", "2734126"], "spl_set_id": ["559e353c-2dc0-16ba-e054-00144ff8d46c"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BOX (70121-2749-1)", "package_ndc": "70121-2749-1", "marketing_start_date": "20250418"}], "brand_name": "TEPADINA", "product_id": "70121-2749_4f44c872-f02d-48cc-b2a4-4e05d2422b72", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "70121-2749", "generic_name": "thiotepa", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TEPADINA", "active_ingredients": [{"name": "THIOTEPA", "strength": "200 mg/1"}], "application_number": "NDA208264", "marketing_category": "NDA", "marketing_start_date": "20250418", "listing_expiration_date": "20271231"}