FDA.reportPublic FDA data

Ramipril

Product NDC
71335-1057
11-digit product format
713351057
Labeler code
71335
Product ID
71335-1057_04104422-e402-4b74-a8c8-83908775dd26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091604
Marketing category
ANDA
Marketing start
2011-06-08
Substance
RAMIPRIL
Active strength
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RAMIPRIL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL35JN3I7SJ
Rxcui198189

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
71335-1057-1Ramipril30 in 1 BOTTLECAPSULE30102
71335-1057-2Ramipril20 in 1 BOTTLECAPSULE20102
71335-1057-3Ramipril90 in 1 BOTTLECAPSULE90102
71335-1057-4Ramipril60 in 1 BOTTLECAPSULE60102
71335-1057-5Ramipril10 in 1 BOTTLECAPSULE10102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1057RAMIPRIL CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20240602_8be00433-3113-437e-8ab6-721af4d79185.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198189ramipril 5 MG Oral CapsulePSN8be00433-3113-437e-8ab6-721af4d79185102
198189ramipril 5 MG Oral CapsuleSCD8be00433-3113-437e-8ab6-721af4d79185102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1057-17133510570130 CAPSULE in 1 BOTTLE (71335-1057-1) 30 capsule2019-01-080000-00-00NoNoCurrent
71335-1057-27133510570220 CAPSULE in 1 BOTTLE (71335-1057-2) 20 capsule2024-05-300000-00-00NoNoCurrent
71335-1057-37133510570390 CAPSULE in 1 BOTTLE (71335-1057-3) 90 capsule2020-10-160000-00-00NoNoCurrent
71335-1057-47133510570460 CAPSULE in 1 BOTTLE (71335-1057-4) 60 capsule2024-05-300000-00-00NoNoCurrent
71335-1057-57133510570510 CAPSULE in 1 BOTTLE (71335-1057-5) 10 capsule2024-05-300000-00-00NoNoCurrent