tranylcypromine

Generic: tranylcypromine

Labeler: novitium pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tranylcypromine
Generic Name tranylcypromine
Labeler novitium pharma llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tranylcypromine sulfate 10 mg/1

Manufacturer
Novitium Pharma LLC

Identifiers & Regulatory

Product NDC 70954-538
Product ID 70954-538_8ab1c887-76fb-44ca-9999-4eefd3778cfc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206856
Listing Expiration 2026-12-31
Marketing Start 2021-06-06

Pharmacologic Class

Classes
monoamine oxidase inhibitor [epc] monoamine oxidase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954538
Hyphenated Format 70954-538

Supplemental Identifiers

RxCUI
313447
UPC
0370954538103
UNII
7ZAT6ES870

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 tranylcypromine (source: ndc)
Generic Name tranylcypromine (source: ndc)
Application Number ANDA206856 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70954-538-10)
source: ndc

Packages (1)

70954-538-10 100 TABLET in 1 BOTTLE (70954-538-10)

Ingredients (1)

tranylcypromine sulfate (10 mg/1)

Linked Drug Pages (1)

Tranylcypromine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8ab1c887-76fb-44ca-9999-4eefd3778cfc", "openfda": {"upc": ["0370954538103"], "unii": ["7ZAT6ES870"], "rxcui": ["313447"], "spl_set_id": ["8ab1c887-76fb-44ca-9999-4eefd3778cfc"], "manufacturer_name": ["Novitium Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70954-538-10)", "package_ndc": "70954-538-10", "marketing_start_date": "20210606"}], "brand_name": "Tranylcypromine", "product_id": "70954-538_8ab1c887-76fb-44ca-9999-4eefd3778cfc", "dosage_form": "TABLET", "pharm_class": ["Monoamine Oxidase Inhibitor [EPC]", "Monoamine Oxidase Inhibitors [MoA]"], "product_ndc": "70954-538", "generic_name": "Tranylcypromine", "labeler_name": "Novitium Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tranylcypromine", "active_ingredients": [{"name": "TRANYLCYPROMINE SULFATE", "strength": "10 mg/1"}], "application_number": "ANDA206856", "marketing_category": "ANDA", "marketing_start_date": "20210606", "listing_expiration_date": "20261231"}