FDA.reportPublic FDA data

Ramipril

Product NDC
65862-477
11-digit product format
658620477
Labeler code
65862
Product ID
65862-477_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
10 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
RAMIPRIL10 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
65862-477-01Ramipril100 in 1 BOTTLECAPSULE10017
65862-477-05Ramipril500 in 1 BOTTLECAPSULE50017
65862-477-10Ramipril10 in 1 BLISTER PACKCAPSULE1017
65862-477-10Ramipril10 in 1 CARTONCAPSULE1017
65862-477-30Ramipril30 in 1 BOTTLECAPSULE3017
65862-477-99Ramipril1000 in 1 BOTTLECAPSULE100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-477-01EA - Each65862-4778518214d-9bc6-48d5-b901-7bcc24d8e59712012-07-24
65862-477-05EA - Each65862-4778683387a-7846-498b-ab1e-52e739ab2a4112012-07-24

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
RAMIPRILACTIVE INGREDIENTL35JN3I7SJRAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.]2
RAMIPRILATACTIVE MOIETY6N5U4QFC3GRAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LRAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71ORAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRAMIPRIL CAPSULE [BLENHEIM PHARMACAL, INC.]2
RAMIPRILACTIVE INGREDIENTL35JN3I7SJRAMIPRIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
RAMIPRILATACTIVE MOIETY6N5U4QFC3GRAMIPRIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRAMIPRIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARAMIPRIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357RAMIPRIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LRAMIPRIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SHELLACINACTIVE INGREDIENT46N107B71ORAMIPRIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RAMIPRIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRAMIPRIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRAMIPRIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRAMIPRIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-477RAMIPRIL 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 CapsulePSN1576188e-efd4-4e14-870e-fd9bd2751c4517
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
198189ramipril 5 MG Oral CapsulePSN1576188e-efd4-4e14-870e-fd9bd2751c4517
845488ramipril 1.25 MG Oral CapsuleSCDd6d57158-e8f9-4c91-8317-0374e0c87d3317
261962ramipril 10 MG Oral CapsuleSCD1576188e-efd4-4e14-870e-fd9bd2751c4517
261962ramipril 10 MG Oral CapsuleSCDd6d57158-e8f9-4c91-8317-0374e0c87d3317
198188ramipril 2.5 MG Oral CapsuleSCDd6d57158-e8f9-4c91-8317-0374e0c87d3317
198189ramipril 5 MG Oral CapsuleSCD1576188e-efd4-4e14-870e-fd9bd2751c4517
198189ramipril 5 MG Oral CapsuleSCDd6d57158-e8f9-4c91-8317-0374e0c87d3317
261962ramipril 10 MG Oral CapsulePSN394a49a8-81bb-43ba-8d6a-fa6fa50305876
261962ramipril 10 MG Oral CapsuleSCD394a49a8-81bb-43ba-8d6a-fa6fa50305876
261962ramipril 10 MG Oral CapsulePSNdd3162eb-5f09-47ac-9efd-3ddeee695a253
261962ramipril 10 MG Oral CapsulePSNafd766bc-2a42-40b5-b33f-1a8b5ce2622e3
261962ramipril 10 MG Oral CapsuleSCDdd3162eb-5f09-47ac-9efd-3ddeee695a253
261962ramipril 10 MG Oral CapsuleSCDafd766bc-2a42-40b5-b33f-1a8b5ce2622e3
261962ramipril 10 MG Oral CapsulePSN0fd77fd3-49c5-09ba-e054-00144ff88e882
261962ramipril 10 MG Oral CapsulePSNf2f325b8-f33d-3b93-e053-2995a90aa6602
261962ramipril 10 MG Oral CapsuleSCD0fd77fd3-49c5-09ba-e054-00144ff88e882
261962ramipril 10 MG Oral CapsuleSCDf2f325b8-f33d-3b93-e053-2995a90aa6602
261962ramipril 10 MG Oral CapsulePSN2b5cc18d-4341-40dd-e054-00144ff88e881
261962ramipril 10 MG Oral CapsulePSN178f647f-efdb-4b33-957a-61fd92c50e4b1
198189ramipril 5 MG Oral CapsulePSN178f647f-efdb-4b33-957a-61fd92c50e4b1
261962ramipril 10 MG Oral CapsuleSCD2b5cc18d-4341-40dd-e054-00144ff88e881
261962ramipril 10 MG Oral CapsuleSCD178f647f-efdb-4b33-957a-61fd92c50e4b1
198189ramipril 5 MG Oral CapsuleSCD178f647f-efdb-4b33-957a-61fd92c50e4b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-477-0165862047701100 CAPSULE in 1 BOTTLE (65862-477-01) 100 capsule2011-06-080000-00-00NoNoCurrent
65862-477-0565862047705500 CAPSULE in 1 BOTTLE (65862-477-05) 500 capsule2011-06-080000-00-00NoNoCurrent
65862-477-106586204771010 BLISTER PACK in 1 CARTON (65862-477-10) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2011-06-080000-00-00NoNoCurrent
65862-477-306586204773030 CAPSULE in 1 BOTTLE (65862-477-30) 30 capsule2011-06-080000-00-00NoNoCurrent
65862-477-49658620477494000 CAPSULE in 1 BAG (65862-477-49)4000 capsule08-JUN-11Current
65862-477-99658620477991000 CAPSULE in 1 BOTTLE (65862-477-99) 1000 capsule2011-06-080000-00-00NoNoCurrent