TRANDOLAPRIL TABLETS Rx only

Manufacturer: Carilion Materials Management
Effective date: 2017-07-06
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 20:24:04

Key Label Information#

Uses

INDICATIONS AND USAGE

CONTRAINDICATIONS

Warnings

WARNING: FETAL TOXICITY

CONTRAINDICATIONS

WARNINGS

Directions And Dosage

OVERDOSAGE

DOSAGE AND ADMINISTRATION

Other Label Information

Trandolapril 1 mg tabs

Label Images#

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
199353	trandolapril 1 MG Oral Tablet	PSN	4
199353	trandolapril 1 MG Oral Tablet	SCD	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
TRANDOLAPRILAT Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
980ce3cc-8943-91ef-56b2-a0bae7a2b9f9	Product name	1	20140508
d3b67bc2-0e96-e3ec-06a9-90afcc07bf13	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68151-0757-0	2020-01-31	C162847	48780-1	9d75b9d0-077e-f424-e053-dadaa90a57ce	TRANDOLAPRIL TABLETS Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68151-0757-0	Trandolapril	1 in 1 PACKAGE	TABLET	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68151-0757	TRANDOLAPRIL TABLET [CARILION MATERIALS MANAGEMENT]	4	Legacy NDC, 1 package rows	20170706_94de983f-549b-42ed-9f40-b022aa3bef0f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-566-01	EA - Each	68180-566	3ae7ad7e-59e5-422e-a49f-ec6fda71ffe1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
TRANDOLAPRIL	ACTIVE INGREDIENT	1T0N3G9CRC	2
TRANDOLAPRILAT	ACTIVE MOIETY	RR6866VL0O	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	2
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	2

Products#

TRANDOLAPRILAT

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68151-0757	68151-0757-0
68180-566

Ingredients#

Name, UNII, Kind table
Name	UNII	Kind
TRANDOLAPRIL	1T0N3G9CRC	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
SODIUM STEARYL FUMARATE	7CV7WJK4UI	IACT
STARCH, CORN	O8232NY3SJ	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
FERRIC OXIDE RED	1K09F3G675	IACT

Complete SPL Sections#

WARNING: FETAL TOXICITY

BOXED WARNING SECTION

DESCRIPTION

DESCRIPTION SECTION

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

WARNINGS

WARNINGS SECTION

PRECAUTIONS

PRECAUTIONS SECTION

Information for Patients

INFORMATION FOR PATIENTS SECTION

Drug Interactions

DRUG INTERACTIONS SECTION

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

OVERDOSAGE

OVERDOSAGE SECTION

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 68151-0757 NDC: 68151-0757-0 1 TABLET in a PACKAGE

SPL UNCLASSIFIED SECTION

Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA. Revised: May 2016 ID#: 245432

Trandolapril 1 mg tabs

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML