Ramipril

Product NDC: 45865-441
11-digit product format: 458650441
Labeler code: 45865
Product ID: 45865-441_9ab23521-8eee-5740-e053-2a95a90a1411
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ramipril
Dosage form: CAPSULE
Route: ORAL
Labeler: Medsource Pharmaceuticals
Application: ANDA077900
Marketing category: ANDA
Marketing start: 2008-06-18
Marketing end: 0000-00-00
Substance: RAMIPRIL
Active strength: 10 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
45865-441-30	2025-01-30	C162847	48780-1	2cef2736-6d3b-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use Ramipril Capsules USP safely and effectively. See full prescribing information for Ramipril Capsules USP. Ramipril Capsules USP, Oral Initial U.S. Approval: 1991
45865-441-49	2025-01-30	C162847	48780-1	2cef2736-6d3b-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use Ramipril Capsules USP safely and effectively. See full prescribing information for Ramipril Capsules USP. Ramipril Capsules USP, Oral Initial U.S. Approval: 1991

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-441-30	Ramipril	30 in 1 BOTTLE	CAPSULE	30		2
45865-441-49	Ramipril	100 in 1 BOTTLE	CAPSULE	100		2

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RAMIPRIL	ACTIVE INGREDIENT	L35JN3I7SJ	RAMIPRIL CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
RAMIPRILAT	ACTIVE MOIETY	6N5U4QFC3G	RAMIPRIL CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	RAMIPRIL CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	RAMIPRIL CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	RAMIPRIL CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RAMIPRIL CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RAMIPRIL CAPSULE [MEDSOURCE PHARMACEUTICALS]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-441	RAMIPRIL CAPSULE [MEDSOURCE PHARMACEUTICALS]	2	Legacy NDC, 2 package rows	20191228_1dc2b41e-97c5-415b-e054-00144ff8d46c.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
261962	ramipril 10 MG Oral Capsule	PSN	1dc2b41e-97c5-415b-e054-00144ff8d46c	2
261962	ramipril 10 MG Oral Capsule	SCD	1dc2b41e-97c5-415b-e054-00144ff8d46c	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-441-30	45865044130	30 CAPSULE in 1 BOTTLE (45865-441-30)	30 capsule	2015-08-26	0000-00-00	No	No	Current
45865-441-49	45865044149	100 CAPSULE in 1 BOTTLE (45865-441-49)	100 capsule	2015-08-26	0000-00-00	No	No	Current