trimethoprim

Generic: trimethoprim

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

Drug Facts

Product Profile

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

trimethoprim 100 mg/1

Manufacturer
Novitium Pharma LLC

Identifiers & Regulatory

Product NDC 70954-541
Product ID 70954-541_95a1572c-6109-4d1f-bf92-262015a7654e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216393
Listing Expiration 2026-12-31
Marketing Start 2022-11-04

Pharmacologic Class

Established (EPC)
dihydrofolate reductase inhibitor antibacterial [epc]
Mechanism of Action
dihydrofolate reductase inhibitors [moa] cytochrome p450 2c8 inhibitors [moa] organic cation transporter 2 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954541
Hyphenated Format 70954-541

Supplemental Identifiers

RxCUI
198332
UPC
0370954541103
UNII
AN164J8Y0X
NUI
N0000175489 N0000000191 N0000187062 N0000187061

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 trimethoprim (source: ndc)
Generic Name trimethoprim (source: ndc)
Application Number ANDA216393 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (70954-541-10)
source: ndc

Packages (1)

70954-541-10 100 TABLET in 1 BOTTLE, PLASTIC (70954-541-10)

Ingredients (1)

trimethoprim (100 mg/1)

Linked Drug Pages (1)

Trimethoprim ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "95a1572c-6109-4d1f-bf92-262015a7654e", "openfda": {"nui": ["N0000175489", "N0000000191", "N0000187062", "N0000187061"], "upc": ["0370954541103"], "unii": ["AN164J8Y0X"], "rxcui": ["198332"], "spl_set_id": ["95a1572c-6109-4d1f-bf92-262015a7654e"], "pharm_class_epc": ["Dihydrofolate Reductase Inhibitor Antibacterial [EPC]"], "pharm_class_moa": ["Dihydrofolate Reductase Inhibitors [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["Novitium Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (70954-541-10)", "package_ndc": "70954-541-10", "marketing_start_date": "20221104"}], "brand_name": "Trimethoprim", "product_id": "70954-541_95a1572c-6109-4d1f-bf92-262015a7654e", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2C8 Inhibitors [MoA]", "Dihydrofolate Reductase Inhibitor Antibacterial [EPC]", "Dihydrofolate Reductase Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]"], "product_ndc": "70954-541", "generic_name": "Trimethoprim", "labeler_name": "Novitium Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Trimethoprim", "active_ingredients": [{"name": "TRIMETHOPRIM", "strength": "100 mg/1"}], "application_number": "ANDA216393", "marketing_category": "ANDA", "marketing_start_date": "20221104", "listing_expiration_date": "20261231"}