Ramipril

Product NDC: 76282-274
11-digit product format: 762820274
Labeler code: 76282
Product ID: 76282-274_af09ebd5-6988-4e8c-b9b1-8e5e9c9520e3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ramipril
Dosage form: CAPSULE
Route: ORAL
Labeler: Exelan Pharmaceuticals, Inc.
Application: ANDA078745
Marketing category: ANDA
Marketing start: 2008-06-27
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: 2018-12-31
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
76282-274-01	2020-01-31	C162847	48780-1	9d75b9d0-6e32-f424-e053-dadaa90a57ce	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
76282-274-05	2020-01-31	C162847	48780-1	9d75b9d0-6e32-f424-e053-dadaa90a57ce	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
76282-274-10	2020-01-31	C162847	48780-1	9d75b9d0-6e32-f424-e053-dadaa90a57ce	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	SPL version
76282-274-01	Ramipril	100 in 1 BOTTLE	CAPSULE	100	3
76282-274-05	Ramipril	500 in 1 BOTTLE	CAPSULE	500	3
76282-274-10	Ramipril	1000 in 1 BOTTLE	CAPSULE	1000	3

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76282-274-01	EA - Each	76282-274	6a4b09da-34f6-4113-936f-06ca940483c4	1	2012-07-24
76282-274-05	EA - Each	76282-274	46ee6b0b-67e2-4112-83f4-2e92cc2fad6d	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RAMIPRIL	ACTIVE INGREDIENT	L35JN3I7SJ	RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.]	1
RAMIPRIL	ACTIVE MOIETY	L35JN3I7SJ	RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76282-274	RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.]	3	Legacy NDC, 3 package rows	20171130_2e6303e8-1c22-451f-8733-a55e237ff961.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
845488	ramipril 1.25 MG Oral Capsule	PSN	2e6303e8-1c22-451f-8733-a55e237ff961	3
261962	ramipril 10 MG Oral Capsule	PSN	2e6303e8-1c22-451f-8733-a55e237ff961	3
198188	ramipril 2.5 MG Oral Capsule	PSN	2e6303e8-1c22-451f-8733-a55e237ff961	3
198189	ramipril 5 MG Oral Capsule	PSN	2e6303e8-1c22-451f-8733-a55e237ff961	3
845488	ramipril 1.25 MG Oral Capsule	SCD	2e6303e8-1c22-451f-8733-a55e237ff961	3
261962	ramipril 10 MG Oral Capsule	SCD	2e6303e8-1c22-451f-8733-a55e237ff961	3
198188	ramipril 2.5 MG Oral Capsule	SCD	2e6303e8-1c22-451f-8733-a55e237ff961	3
198189	ramipril 5 MG Oral Capsule	SCD	2e6303e8-1c22-451f-8733-a55e237ff961	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
76282-274-01	76282027401	100 in 1 BOTTLE	Historical
76282-274-05	76282027405	500 in 1 BOTTLE	Historical
76282-274-10	76282027410	1000 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ramipril	Exelan Pharmaceuticals, Inc. \| InvaGen Pharmaceuticals, Inc. \| InvaGen Pharmaceuticals, Inc	2017-11-30	Human Prescription Drug Label	3