Trandolapril

Product NDC: 57237-090
11-digit product format: 572370090
Labeler code: 57237
Product ID: 57237-090_3c365d52-7f5f-477f-8342-4c507b2a7936
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trandolapril
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA078438
Marketing category: ANDA
Marketing start: 2007-06-12
Substance: TRANDOLAPRIL
Active strength: 2 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
TRANDOLAPRIL	2 mg/1

Field, Values table
Field	Values
Unii	1T0N3G9CRC
Rxcui	199351, 199352, 199353

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57237-090-01	Trandolapril	100 in 1 BOTTLE	TABLET	100		7

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-090-01	EA - Each	57237-090	97c90557-ed94-4348-ba50-56fb370dba72	1	2015-10-02

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRANDOLAPRIL	ACTIVE INGREDIENT	1T0N3G9CRC	TRANDOLAPRIL TABLET [CITRON PHARMA LLC]	2
TRANDOLAPRILAT	ACTIVE MOIETY	RR6866VL0O	TRANDOLAPRIL TABLET [CITRON PHARMA LLC]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	TRANDOLAPRIL TABLET [CITRON PHARMA LLC]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TRANDOLAPRIL TABLET [CITRON PHARMA LLC]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TRANDOLAPRIL TABLET [CITRON PHARMA LLC]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	TRANDOLAPRIL TABLET [CITRON PHARMA LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TRANDOLAPRIL TABLET [CITRON PHARMA LLC]	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	TRANDOLAPRIL TABLET [CITRON PHARMA LLC]	2
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	TRANDOLAPRIL TABLET [CITRON PHARMA LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRANDOLAPRIL TABLET [CITRON PHARMA LLC]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-090	TRANDOLAPRIL TABLET [RISING PHARMA HOLDINGS, INC.]	7	Current NDC, Legacy NDC, 1 package rows	20240424_0107d19a-b43a-4a36-8b8c-4dfc247630e9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1T0N3G9CRC	TRANDOLAPRIL	87679-37-6	TRANDOLAPRIL

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199353	trandolapril 1 MG Oral Tablet	PSN	0107d19a-b43a-4a36-8b8c-4dfc247630e9	7
199351	trandolapril 2 MG Oral Tablet	PSN	0107d19a-b43a-4a36-8b8c-4dfc247630e9	7
199352	trandolapril 4 MG Oral Tablet	PSN	0107d19a-b43a-4a36-8b8c-4dfc247630e9	7
199353	trandolapril 1 MG Oral Tablet	SCD	0107d19a-b43a-4a36-8b8c-4dfc247630e9	7
199351	trandolapril 2 MG Oral Tablet	SCD	0107d19a-b43a-4a36-8b8c-4dfc247630e9	7
199352	trandolapril 4 MG Oral Tablet	SCD	0107d19a-b43a-4a36-8b8c-4dfc247630e9	7
199351	trandolapril 2 MG Oral Tablet	PSN	57f8aac6-3bd3-4ae1-aab2-759c8bc23292	5
199351	trandolapril 2 MG Oral Tablet	SCD	57f8aac6-3bd3-4ae1-aab2-759c8bc23292	5
199351	trandolapril 2 MG Oral Tablet	PSN	1d778603-13cb-4110-9d45-8df3438d13ca	4
199351	trandolapril 2 MG Oral Tablet	SCD	1d778603-13cb-4110-9d45-8df3438d13ca	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-090-01	57237009001	100 TABLET in 1 BOTTLE (57237-090-01)	100 tablet	2007-06-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trandolapril Tablets USP Rx only	Bryant Ranch Prepack	2024-05-30	HUMAN PRESCRIPTION DRUG LABEL	5
Trandolapril Tablets USP Rx only	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2024-04-18	Human Prescription Drug Label	7
Trandolapril Tablets USP Rx only	A-S Medication Solutions	2019-04-30	Human Prescription Drug Label	4