thiotepa

Generic: thiotepa

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name thiotepa
Generic Name thiotepa
Labeler gland pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRACAVITARY INTRAVENOUS INTRAVESICAL
Active Ingredients

thiotepa 100 mg/1

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-503
Product ID 68083-503_164faf7b-519a-41f7-a760-eb2a81b9f040
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214222
Listing Expiration 2027-12-31
Marketing Start 2022-01-03

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 68083503
Hyphenated Format 68083-503

Supplemental Identifiers

RxCUI
1660004 1660009
UPC
0368083503017
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 (68083-503-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
source: ndc

Packages (1)

68083-503-01 1 VIAL in 1 CARTON (68083-503-01) / 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": "164faf7b-519a-41f7-a760-eb2a81b9f040", "openfda": {"nui": ["N0000000236", "N0000175558"], "upc": ["0368083503017"], "unii": ["905Z5W3GKH"], "rxcui": ["1660004", "1660009"], "spl_set_id": ["6cd6ae89-c553-4328-9262-4363610a1f19"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-503-01)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "68083-503-01", "marketing_start_date": "20220103"}], "brand_name": "Thiotepa", "product_id": "68083-503_164faf7b-519a-41f7-a760-eb2a81b9f040", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "68083-503", "generic_name": "Thiotepa", "labeler_name": "Gland Pharma Limited", "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": "20220103", "listing_expiration_date": "20271231"}