FDA.reportPublic FDA data

Ramipril

Product NDC
50090-1118
11-digit product format
500901118
Labeler code
50090
Product ID
50090-1118_c3654e93-3d23-4001-92e8-80ff0eadd754
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9a7d2f1c-330a-4830-b88b-315f5c1bab6bProduct name120151208
c76eceed-99b6-9572-9f36-9ac63b4b3ce4Product name220141218

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1118-02023-11-26C16284748780-1f386c649-d700-0266-e053-dadaa90a7c1aThese 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
50090-1118-12023-11-26C16284748780-1f386c649-d700-0266-e053-dadaa90a7c1aThese 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
50090-1118-02023-01-30C16284748780-1f386c649-d700-0266-e053-dadaa90a7c1aThese 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
50090-1118-12023-01-30C16284748780-1f386c649-d700-0266-e053-dadaa90a7c1aThese 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1118-0Ramipril30 in 1 BOTTLECAPSULE3017
50090-1118-1Ramipril90 in 1 BOTTLECAPSULE9017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1118-0EA - Each50090-111827ff1261-06e7-42f3-9a0d-d86a4a56377c12018-11-06
50090-1118-1EA - Each50090-11185110e9a1-8dbe-4127-ab0a-9f057d1a11b412018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1118RAMIPRIL CAPSULE [A-S MEDICATION SOLUTIONS]17Legacy NDC, 2 package rows20250417_1576188e-efd4-4e14-870e-fd9bd2751c45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
261962ramipril 10 MG Oral CapsulePSN1576188e-efd4-4e14-870e-fd9bd2751c4517
198189ramipril 5 MG Oral CapsulePSN1576188e-efd4-4e14-870e-fd9bd2751c4517
261962ramipril 10 MG Oral CapsuleSCD1576188e-efd4-4e14-870e-fd9bd2751c4517
198189ramipril 5 MG Oral CapsuleSCD1576188e-efd4-4e14-870e-fd9bd2751c4517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1118-05009011180030 in 1 BOTTLEHistorical
50090-1118-15009011180190 CAPSULE in 1 BOTTLE (50090-1118-1) 90 capsule2014-11-280000-00-00NoNoCurrent