FDA.reportPublic FDA data

Ramipril

Product NDC
57237-225
11-digit product format
572370225
Labeler code
57237
Product ID
57237-225_62ad78f6-6c57-4157-aae9-130ff95d57dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
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
Rxcui198188, 198189, 261962, 845488

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
57237-225-01Ramipril100 in 1 BOTTLECAPSULE1008
57237-225-05Ramipril500 in 1 BOTTLECAPSULE5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-225-01EA - Each57237-22539b1b2bf-8dbd-4fae-bd78-fe78149dadb612017-05-04
57237-225-05EA - Each57237-225be8e49a5-4a5b-4e41-8268-fc6c71f743e812017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-225RAMIPRIL CAPSULE [RISING PHARMA HOLDINGS, INC.]7Current NDC, Legacy NDC, 2 package rows20240501_d5c58fb5-b415-4567-9790-55631705c5cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
845488ramipril 1.25 MG Oral CapsulePSNd5c58fb5-b415-4567-9790-55631705c5cd8
261962ramipril 10 MG Oral CapsulePSNd5c58fb5-b415-4567-9790-55631705c5cd8
261962ramipril 10 MG Oral CapsulePSNd856fb57-f1a0-49e6-bb2d-b4924af485158
198188ramipril 2.5 MG Oral CapsulePSNd5c58fb5-b415-4567-9790-55631705c5cd8
198189ramipril 5 MG Oral CapsulePSNd5c58fb5-b415-4567-9790-55631705c5cd8
845488ramipril 1.25 MG Oral CapsuleSCDd5c58fb5-b415-4567-9790-55631705c5cd8
261962ramipril 10 MG Oral CapsuleSCDd5c58fb5-b415-4567-9790-55631705c5cd8
261962ramipril 10 MG Oral CapsuleSCDd856fb57-f1a0-49e6-bb2d-b4924af485158
198188ramipril 2.5 MG Oral CapsuleSCDd5c58fb5-b415-4567-9790-55631705c5cd8
198189ramipril 5 MG Oral CapsuleSCDd5c58fb5-b415-4567-9790-55631705c5cd8
261962ramipril 10 MG Oral CapsulePSNe8d9a115-71a7-4580-abbd-865e98b5d3f67
261962ramipril 10 MG Oral CapsuleSCDe8d9a115-71a7-4580-abbd-865e98b5d3f67
261962ramipril 10 MG Oral CapsulePSNfb0892da-3db7-3202-e053-6394a90ab6054
261962ramipril 10 MG Oral CapsuleSCDfb0892da-3db7-3202-e053-6394a90ab6054
261962ramipril 10 MG Oral CapsulePSN543914e5-c164-4fc7-8007-9fab2b13dda73
261962ramipril 10 MG Oral CapsuleSCD543914e5-c164-4fc7-8007-9fab2b13dda73
261962ramipril 10 MG Oral CapsulePSN4bd2d586-6851-4a40-e063-6394a90a0cab1
261962ramipril 10 MG Oral CapsuleSCD4bd2d586-6851-4a40-e063-6394a90a0cab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-225-0157237022501100 CAPSULE in 1 BOTTLE (57237-225-01) 100 capsule2011-06-080000-00-00NoNoCurrent
57237-225-0557237022505500 CAPSULE in 1 BOTTLE (57237-225-05) 500 capsule2011-06-080000-00-00NoNoCurrent