FDA.reportPublic FDA data

Ramipril

Product NDC
50090-5730
11-digit product format
500905730
Labeler code
50090
Product ID
50090-5730_7aba88d3-08f6-47b7-8496-0aee3448f686
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
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ramipril
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RAMIPRIL10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL35JN3I7SJ
Rxcui261962

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
50090-5730-02023-02-07C16284748780-1f386c649-e374-0266-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
50090-5730-12023-02-07C16284748780-1f386c649-e374-0266-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
50090-5730-02023-01-30C16284748780-1f386c649-e374-0266-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
50090-5730-12023-01-30C16284748780-1f386c649-e374-0266-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
50090-5730-0Ramipril30 in 1 BOTTLECAPSULE307
50090-5730-1Ramipril90 in 1 BOTTLECAPSULE907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5730RAMIPRIL CAPSULE [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20231204_e8d9a115-71a7-4580-abbd-865e98b5d3f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
261962ramipril 10 MG Oral CapsulePSNe8d9a115-71a7-4580-abbd-865e98b5d3f67
261962ramipril 10 MG Oral CapsuleSCDe8d9a115-71a7-4580-abbd-865e98b5d3f67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5730-05009057300030 CAPSULE in 1 BOTTLE (50090-5730-0) 30 capsule2021-09-280000-00-00NoNoCurrent
50090-5730-15009057300190 CAPSULE in 1 BOTTLE (50090-5730-1) 90 capsule2021-09-280000-00-00NoNoCurrent