FDA.reportPublic FDA data

Ramipril

Product NDC
63187-816
11-digit product format
631870816
Labeler code
63187
Product ID
63187-816_cd41f0ae-d2bb-4ffc-9a5e-7ca6345cbe89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ramipril
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-816-30Ramipril30 in 1 BOTTLECAPSULE303
63187-816-60Ramipril60 in 1 BOTTLECAPSULE603
63187-816-90Ramipril90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-816-30EA - Each63187-816895df5e9-65d3-4be4-8b06-50fec9e3b9e112017-03-06
63187-816-90EA - Each63187-816e54f88d4-a594-4cea-96a1-a4fb2ada3db012017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-816RAMIPRIL CAPSULE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20191113_afd766bc-2a42-40b5-b33f-1a8b5ce2622e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
261962ramipril 10 MG Oral CapsulePSNafd766bc-2a42-40b5-b33f-1a8b5ce2622e3
261962ramipril 10 MG Oral CapsuleSCDafd766bc-2a42-40b5-b33f-1a8b5ce2622e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-816-306318708163030 CAPSULE in 1 BOTTLE (63187-816-30) 30 capsule2017-02-010000-00-00NoNoCurrent
63187-816-606318708166060 CAPSULE in 1 BOTTLE (63187-816-60) 60 capsule2017-02-010000-00-00NoNoCurrent
63187-816-906318708169090 CAPSULE in 1 BOTTLE (63187-816-90) 90 capsule2017-02-010000-00-00NoNoCurrent