FDA.reportPublic FDA data

Ramipril

Product NDC
51655-346
11-digit product format
516550346
Labeler code
51655
Product ID
51655-346_48eb4c0d-97d5-db3e-e063-6294a90acd7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA077626
Marketing category
ANDA
Marketing start
2020-05-27
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
51655-346-262023-03-27C16284748780-1f386c64a-01b8-0266-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
51655-346-262023-01-30C16284748780-1f386c64a-01b8-0266-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
51655-346-26Ramipril90 in 1 BOTTLE, PLASTICCAPSULE905
51655-346-52Ramipril30 in 1 BOTTLE, PLASTICCAPSULE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-346RAMIPRIL CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20241219_ab3124b7-deed-8e04-e053-2a95a90a3b85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
261962ramipril 10 MG Oral CapsulePSNab3124b7-deed-8e04-e053-2a95a90a3b855
261962ramipril 10 MG Oral CapsuleSCDab3124b7-deed-8e04-e053-2a95a90a3b855

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-346-265165503462690 CAPSULE in 1 BOTTLE, PLASTIC (51655-346-26) 90 capsule2020-05-270000-00-00NoNoCurrent
51655-346-525165503465230 CAPSULE in 1 BOTTLE, PLASTIC (51655-346-52) 30 capsule2020-10-27NoNoCurrent