FDA.reportPublic FDA data

Ramipril

Product NDC
51655-904
11-digit product format
516550904
Labeler code
51655
Product ID
51655-904_4bbd26bc-4089-e73e-e063-6294a90a3ad9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA091604
Marketing category
ANDA
Marketing start
2023-04-27
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
51655-904-262026-01-29C16284748780-149896155-d653-586f-e063-e6dba90add90These 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
51655-904-522026-01-29C16284748780-149896155-d653-586f-e063-e6dba90add90These 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
51655-904-26Ramipril90 in 1 BOTTLE, PLASTICCAPSULE904
51655-904-52Ramipril30 in 1 BOTTLE, PLASTICCAPSULE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-904RAMIPRIL CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20230630_fb0892da-3db7-3202-e053-6394a90ab605.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
261962ramipril 10 MG Oral CapsulePSNfb0892da-3db7-3202-e053-6394a90ab6054
261962ramipril 10 MG Oral CapsuleSCDfb0892da-3db7-3202-e053-6394a90ab6054

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-904-265165509042690 CAPSULE in 1 BOTTLE, PLASTIC (51655-904-26) 90 capsule2023-04-27NoNoCurrent
51655-904-525165509045230 CAPSULE in 1 BOTTLE, PLASTIC (51655-904-52) 30 capsule2023-04-27NoNoCurrent