Ramipril

Product NDC: 50090-4597
11-digit product format: 500904597
Labeler code: 50090
Product ID: 50090-4597_ea288295-c479-450f-95df-856c5ed5e69b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ramipril
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA077626
Marketing category: ANDA
Marketing start: 2008-06-10
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: 2022-12-31
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
50090-4597-0	2023-01-30	C162847	48780-1	f386c64a-3665-0266-e053-dadaa90a7c1a	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
50090-4597-1	2023-01-30	C162847	48780-1	f386c64a-3665-0266-e053-dadaa90a7c1a	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
50090-4597-0	Ramipril	30 in 1 BOTTLE	CAPSULE	30		4
50090-4597-1	Ramipril	90 in 1 BOTTLE	CAPSULE	90		4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4597	RAMIPRIL CAPSULE [A-S MEDICATION SOLUTIONS]	4	Legacy NDC, 2 package rows	20210417_4d263598-2e57-467f-98e5-411b82e6fc2b.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	4d263598-2e57-467f-98e5-411b82e6fc2b	4
198189	ramipril 5 MG Oral Capsule	SCD	4d263598-2e57-467f-98e5-411b82e6fc2b	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4597-0	50090459700	30 CAPSULE in 1 BOTTLE (50090-4597-0)	30 capsule	2019-10-10	0000-00-00	No	No	Current
50090-4597-1	50090459701	90 CAPSULE in 1 BOTTLE (50090-4597-1)	90 capsule	2019-10-10	0000-00-00	No	No	Current