Ramipril

Product NDC: 45865-443
11-digit product format: 458650443
Labeler code: 45865
Product ID: 45865-443_71c7a685-c653-d801-e053-2a95a90aec5f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ramipril
Dosage form: CAPSULE
Route: ORAL
Labeler: Medsource Pharmaceuticals
Application: ANDA091604
Marketing category: ANDA
Marketing start: 2011-06-08
Marketing end: 0000-00-00
Substance: RAMIPRIL
Active strength: 5 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9a7d2f1c-330a-4830-b88b-315f5c1bab6b	Product name	1	20151208
c76eceed-99b6-9572-9f36-9ac63b4b3ce4	Product name	2	20141218

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-443-49	2025-01-30	C162847	48780-1	2cef2736-af63-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use RAMIPRIL CAPSULES safely and effectively. See full prescribing information for RAMIPRIL CAPSULES. RAMIPRIL capsules, for oral use Initial U.S. Approval: 1991
45865-443-60	2025-01-30	C162847	48780-1	2cef2736-af63-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use RAMIPRIL CAPSULES safely and effectively. See full prescribing information for RAMIPRIL CAPSULES. RAMIPRIL capsules, for oral use Initial U.S. Approval: 1991

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-443-49	Ramipril	100 in 1 BOTTLE	CAPSULE	100		1
45865-443-60	Ramipril	60 in 1 BOTTLE	CAPSULE	60		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-443	RAMIPRIL CAPSULE [MEDSOURCE PHARMACEUTICALS]	1	Legacy NDC, 2 package rows	20180725_71c7a685-c652-d801-e053-2a95a90aec5f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L35JN3I7SJ	RAMIPRIL	87333-19-5	RAMIPRIL

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198189	ramipril 5 MG Oral Capsule	PSN	71c7a685-c652-d801-e053-2a95a90aec5f	1
198189	ramipril 5 MG Oral Capsule	SCD	71c7a685-c652-d801-e053-2a95a90aec5f	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-443-49	45865044349	100 CAPSULE in 1 BOTTLE (45865-443-49)	100 capsule	2018-01-01	0000-00-00	No	No	Current
45865-443-60	45865044360	60 CAPSULE in 1 BOTTLE (45865-443-60)	60 capsule	2018-01-01	0000-00-00	No	No	Current