FDA.reportPublic FDA data

Ramipril

Product NDC
71335-9645
11-digit product format
713359645
Labeler code
71335
Product ID
71335-9645_0114712a-1579-4fef-8290-3519d069c519
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077626
Marketing category
ANDA
Marketing start
2008-06-10
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
2027-12-31
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
71335-9645-1Ramipril30 in 1 BOTTLECAPSULE30103
71335-9645-2Ramipril20 in 1 BOTTLECAPSULE20103
71335-9645-3Ramipril90 in 1 BOTTLECAPSULE90103
71335-9645-4Ramipril60 in 1 BOTTLECAPSULE60103
71335-9645-5Ramipril10 in 1 BOTTLECAPSULE10103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9645RAMIPRIL CAPSULE [BRYANT RANCH PREPACK]102Current NDC, 5 package rows20240407_3806abdc-6aec-4252-bd79-e2c115b849aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198189ramipril 5 MG Oral CapsulePSN3806abdc-6aec-4252-bd79-e2c115b849aa103
198189ramipril 5 MG Oral CapsuleSCD3806abdc-6aec-4252-bd79-e2c115b849aa103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9645-17133596450130 CAPSULE in 1 BOTTLE (71335-9645-1) 30 capsule2023-04-18NoNoHistorical
71335-9645-27133596450220 CAPSULE in 1 BOTTLE (71335-9645-2) 20 capsule2026-04-15NoNoHistorical
71335-9645-37133596450390 CAPSULE in 1 BOTTLE (71335-9645-3) 90 capsule2026-04-15NoNoHistorical
71335-9645-47133596450460 CAPSULE in 1 BOTTLE (71335-9645-4) 60 capsule2026-04-15NoNoHistorical
71335-9645-57133596450510 CAPSULE in 1 BOTTLE (71335-9645-5) 10 capsule2026-04-15NoNoHistorical