trandolapril

Generic: trandolapril

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

Drug Facts

Product Profile

Brand Name trandolapril
Generic Name trandolapril
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

trandolapril 1 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-164
Product ID 65862-164_004262f3-c8d0-43c9-a760-641c22748858
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078438
Listing Expiration 2026-12-31
Marketing Start 2007-06-12

Pharmacologic Class

Established (EPC)
angiotensin converting enzyme inhibitor [epc]
Mechanism of Action
angiotensin-converting enzyme inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862164
Hyphenated Format 65862-164

Supplemental Identifiers

RxCUI
199351 199352 199353
UNII
1T0N3G9CRC
NUI
N0000175562 N0000000181

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 trandolapril (source: ndc)
Generic Name trandolapril (source: ndc)
Application Number ANDA078438 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (65862-164-01)
  • 1000 TABLET in 1 BOTTLE (65862-164-99)
source: ndc

Packages (2)

65862-164-01 100 TABLET in 1 BOTTLE (65862-164-01) 65862-164-99 1000 TABLET in 1 BOTTLE (65862-164-99)

Ingredients (1)

trandolapril (1 mg/1)

Linked Drug Pages (1)

Trandolapril ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "004262f3-c8d0-43c9-a760-641c22748858", "openfda": {"nui": ["N0000175562", "N0000000181"], "unii": ["1T0N3G9CRC"], "rxcui": ["199351", "199352", "199353"], "spl_set_id": ["6f25ed16-e5e9-4170-b4b4-3b460887779e"], "pharm_class_epc": ["Angiotensin Converting Enzyme Inhibitor [EPC]"], "pharm_class_moa": ["Angiotensin-converting Enzyme Inhibitors [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (65862-164-01)", "package_ndc": "65862-164-01", "marketing_start_date": "20070612"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65862-164-99)", "package_ndc": "65862-164-99", "marketing_start_date": "20070612"}], "brand_name": "Trandolapril", "product_id": "65862-164_004262f3-c8d0-43c9-a760-641c22748858", "dosage_form": "TABLET", "pharm_class": ["Angiotensin Converting Enzyme Inhibitor [EPC]", "Angiotensin-converting Enzyme Inhibitors [MoA]"], "product_ndc": "65862-164", "generic_name": "Trandolapril", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Trandolapril", "active_ingredients": [{"name": "TRANDOLAPRIL", "strength": "1 mg/1"}], "application_number": "ANDA078438", "marketing_category": "ANDA", "marketing_start_date": "20070612", "listing_expiration_date": "20261231"}