FDA.reportPublic FDA data

Ramipril

Product NDC
63187-915
11-digit product format
631870915
Labeler code
63187
Product ID
63187-915_c8c3c559-7a98-49c0-a386-a3b74b0ac4b2
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
2.5 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
RAMIPRIL2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL35JN3I7SJ
Rxcui198188

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
63187-915-30Ramipril30 in 1 BOTTLECAPSULE303
63187-915-60Ramipril60 in 1 BOTTLECAPSULE603
63187-915-90Ramipril90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-915-30EA - Each63187-915cdf805bc-8637-400c-8afe-6cd914ce5efc12018-02-20
63187-915-90EA - Each63187-9150442221b-fb88-40c3-acbd-4118cbae093012017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-915RAMIPRIL CAPSULE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20191108_33bdfe96-1b7a-4859-b1c9-ef94b8bb7a2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198188ramipril 2.5 MG Oral CapsulePSN33bdfe96-1b7a-4859-b1c9-ef94b8bb7a2a3
198188ramipril 2.5 MG Oral CapsuleSCD33bdfe96-1b7a-4859-b1c9-ef94b8bb7a2a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-915-306318709153030 CAPSULE in 1 BOTTLE (63187-915-30) 30 capsule2017-09-010000-00-00NoNoCurrent
63187-915-606318709156060 CAPSULE in 1 BOTTLE (63187-915-60) 60 capsule2017-09-010000-00-00NoNoCurrent
63187-915-906318709159090 CAPSULE in 1 BOTTLE (63187-915-90) 90 capsule2017-09-010000-00-00NoNoCurrent