FDA.reportPublic FDA data

Ramipril

Product NDC
65862-475
11-digit product format
658620475
Labeler code
65862
Product ID
65862-475_b8cfe093-4dcc-4b8b-9c15-7bc70d7903cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
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, 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
65862-475-01Ramipril100 in 1 BOTTLECAPSULE10017
65862-475-05Ramipril500 in 1 BOTTLECAPSULE50017
65862-475-10Ramipril10 in 1 BLISTER PACKCAPSULE1017
65862-475-10Ramipril10 in 1 CARTONCAPSULE1017
65862-475-30Ramipril30 in 1 BOTTLECAPSULE3017
65862-475-99Ramipril1000 in 1 BOTTLECAPSULE100017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-475RAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]17Current NDC, Legacy NDC, 6 package rows20240426_d6d57158-e8f9-4c91-8317-0374e0c87d33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
845488ramipril 1.25 MG Oral CapsulePSNd6d57158-e8f9-4c91-8317-0374e0c87d3317
261962ramipril 10 MG Oral CapsulePSNd6d57158-e8f9-4c91-8317-0374e0c87d3317
198188ramipril 2.5 MG Oral CapsulePSNd6d57158-e8f9-4c91-8317-0374e0c87d3317
198189ramipril 5 MG Oral CapsulePSNd6d57158-e8f9-4c91-8317-0374e0c87d3317
845488ramipril 1.25 MG Oral CapsuleSCDd6d57158-e8f9-4c91-8317-0374e0c87d3317
261962ramipril 10 MG Oral CapsuleSCDd6d57158-e8f9-4c91-8317-0374e0c87d3317
198188ramipril 2.5 MG Oral CapsuleSCDd6d57158-e8f9-4c91-8317-0374e0c87d3317
198189ramipril 5 MG Oral CapsuleSCDd6d57158-e8f9-4c91-8317-0374e0c87d3317
198188ramipril 2.5 MG Oral CapsulePSN4a91b706-c614-4472-92f2-4da5d7bdbf277
198188ramipril 2.5 MG Oral CapsuleSCD4a91b706-c614-4472-92f2-4da5d7bdbf277
198188ramipril 2.5 MG Oral CapsulePSN33bdfe96-1b7a-4859-b1c9-ef94b8bb7a2a3
198188ramipril 2.5 MG Oral CapsuleSCD33bdfe96-1b7a-4859-b1c9-ef94b8bb7a2a3
198188ramipril 2.5 MG Oral CapsulePSNf7e61b5b-fb5b-ba15-e053-6394a90adc3c2
198188ramipril 2.5 MG Oral CapsuleSCDf7e61b5b-fb5b-ba15-e053-6394a90adc3c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-475-0165862047501100 CAPSULE in 1 BOTTLE (65862-475-01) 100 capsule2011-06-080000-00-00NoNoCurrent
65862-475-0565862047505500 CAPSULE in 1 BOTTLE (65862-475-05) 500 capsule2011-06-080000-00-00NoNoCurrent
65862-475-106586204751010 BLISTER PACK in 1 CARTON (65862-475-10) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2011-06-080000-00-00NoNoCurrent
65862-475-306586204753030 CAPSULE in 1 BOTTLE (65862-475-30) 30 capsule2011-06-080000-00-00NoNoCurrent
65862-475-49658620475494000 CAPSULE in 1 BAG (65862-475-49)4000 capsule08-JUN-11Current
65862-475-99658620475991000 CAPSULE in 1 BOTTLE (65862-475-99) 1000 capsule2011-06-080000-00-00NoNoCurrent