Ramipril

Product NDC
65862-474
11-digit product format
658620474
Labeler code
65862
Product ID
65862-474_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
1.25 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
RAMIPRIL1.25 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
65862-474-01Ramipril100 in 1 BOTTLECAPSULE10017
65862-474-10Ramipril10 in 1 BLISTER PACKCAPSULE1017
65862-474-10Ramipril10 in 1 CARTONCAPSULE1017
65862-474-30Ramipril30 in 1 BOTTLECAPSULE3017
65862-474-99Ramipril1000 in 1 BOTTLECAPSULE100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-474-01EA - Each65862-47495a77ea6-d852-42e5-803c-e7c627f42e0012013-02-13
65862-474-30EA - Each65862-4746ba0ebac-0780-4ca4-8e4e-df4ffe3c22bd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RAMIPRILACTIVE INGREDIENTL35JN3I7SJRAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
RAMIPRILATACTIVE MOIETY6N5U4QFC3GRAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357RAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
GELATININACTIVE INGREDIENT2G86QN327LRAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
SHELLACINACTIVE INGREDIENT46N107B71ORAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-474RAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]17Current NDC, Legacy NDC, 5 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-474-0165862047401100 CAPSULE in 1 BOTTLE (65862-474-01) 100 capsule2011-06-080000-00-00NoNoCurrent
65862-474-106586204741010 BLISTER PACK in 1 CARTON (65862-474-10) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2011-06-080000-00-00NoNoCurrent
65862-474-306586204743030 CAPSULE in 1 BOTTLE (65862-474-30) 30 capsule2011-06-080000-00-00NoNoCurrent
65862-474-49658620474494000 CAPSULE in 1 BAG (65862-474-49)4000 capsule08-JUN-11Current
65862-474-99658620474991000 CAPSULE in 1 BOTTLE (65862-474-99) 1000 capsule2011-06-080000-00-00NoNoCurrent