Ramipril

Product NDC: 10544-588
11-digit product format: 105440588
Labeler code: 10544
Product ID: 10544-588_0fd762c0-ff4d-1f25-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ramipril
Dosage form: CAPSULE
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA091604
Marketing category: ANDA
Marketing start: 2014-01-13
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: E
Listing certified through: 2017-12-31
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
10544-588-30	2020-01-31	C162847	48780-1	9d75b9d0-5a9a-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use ramipril safely and effectively. See full prescribing information for ramipril capsules, USP. RAMIPRIL Capsules USP, for oral use Initial U.S. Approval: 1991

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-588-30	Ramipril	30 in 1 BOTTLE	CAPSULE	30		2

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-588-30	EA - Each	10544-588	69064223-9010-41fa-a791-2e7641e02857	1	2015-05-05

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RAMIPRIL	ACTIVE INGREDIENT	L35JN3I7SJ	RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
RAMIPRILAT	ACTIVE MOIETY	6N5U4QFC3G	RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-588	RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2	Legacy NDC, 1 package rows	20150224_0fd77fd3-49c5-09ba-e054-00144ff88e88.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	0fd77fd3-49c5-09ba-e054-00144ff88e88	2
261962	ramipril 10 MG Oral Capsule	SCD	0fd77fd3-49c5-09ba-e054-00144ff88e88	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-588-30	10544058830	30 in 1 BOTTLE	Historical