thiotepa

Generic: thiotepa

Labeler: dr.reddy's laboratories inc.,
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name thiotepa
Generic Name thiotepa
Labeler dr.reddy's laboratories inc.,
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRACAVITARY INTRAVENOUS INTRAVESICAL
Active Ingredients

thiotepa 15 mg/1

Manufacturer
Dr.Reddy's Laboratories Inc.,

Identifiers & Regulatory

Product NDC 43598-650
Product ID 43598-650_e880a370-00f9-f7c7-a992-64756718360b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210337
Listing Expiration 2026-12-31
Marketing Start 2018-05-04

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 43598650
Hyphenated Format 43598-650

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 ANDA210337 (source: ndc)
Routes
INTRACAVITARY INTRAVENOUS INTRAVESICAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (43598-650-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
source: ndc

Packages (1)

43598-650-11 1 VIAL in 1 CARTON (43598-650-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

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": "e880a370-00f9-f7c7-a992-64756718360b", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["905Z5W3GKH"], "rxcui": ["1660009"], "spl_set_id": ["0def6a5e-4bf5-b1fd-47b7-0f17ecfd9bc2"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Dr.Reddy's Laboratories Inc.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (43598-650-11)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "43598-650-11", "marketing_start_date": "20180504"}], "brand_name": "Thiotepa", "product_id": "43598-650_e880a370-00f9-f7c7-a992-64756718360b", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "43598-650", "generic_name": "Thiotepa", "labeler_name": "Dr.Reddy's Laboratories Inc.,", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Thiotepa", "active_ingredients": [{"name": "THIOTEPA", "strength": "15 mg/1"}], "application_number": "ANDA210337", "marketing_category": "ANDA", "marketing_start_date": "20180504", "listing_expiration_date": "20261231"}