FDA.reportPublic FDA data

Ramipril

Product NDC
71335-1056
11-digit product format
713351056
Labeler code
71335
Product ID
71335-1056_7fd47201-f951-4026-8ebd-b7bd8eabc6cc
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
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
2027-12-31

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
71335-1056-1Ramipril30 in 1 BOTTLECAPSULE30102
71335-1056-2Ramipril60 in 1 BOTTLECAPSULE60102
71335-1056-3Ramipril28 in 1 BOTTLECAPSULE28102
71335-1056-4Ramipril90 in 1 BOTTLECAPSULE90102
71335-1056-5Ramipril10 in 1 BOTTLECAPSULE10102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1056RAMIPRIL CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20240602_ef05b44e-4bf7-4afa-a5f6-06efa0d0abc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198188ramipril 2.5 MG Oral CapsulePSNef05b44e-4bf7-4afa-a5f6-06efa0d0abc3102
198188ramipril 2.5 MG Oral CapsuleSCDef05b44e-4bf7-4afa-a5f6-06efa0d0abc3102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1056-17133510560130 CAPSULE in 1 BOTTLE (71335-1056-1) 30 capsule2019-01-080000-00-00NoNoCurrent
71335-1056-27133510560260 CAPSULE in 1 BOTTLE (71335-1056-2) 60 capsule2024-05-300000-00-00NoNoCurrent
71335-1056-37133510560328 CAPSULE in 1 BOTTLE (71335-1056-3) 28 capsule2024-05-300000-00-00NoNoCurrent
71335-1056-47133510560490 CAPSULE in 1 BOTTLE (71335-1056-4) 90 capsule2022-07-190000-00-00NoNoCurrent
71335-1056-57133510560510 CAPSULE in 1 BOTTLE (71335-1056-5) 10 capsule2024-05-300000-00-00NoNoCurrent