Ramipril

Product NDC
65841-658
11-digit product format
658410658
Labeler code
65841
Product ID
65841-658_1d7227b2-6052-40b4-bf22-29f18672ce08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA078832
Marketing category
ANDA
Marketing start
2010-11-20
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
65841-658-01Ramipril100 in 1 BOTTLECAPSULE1008
65841-658-05Ramipril500 in 1 BOTTLECAPSULE5008
65841-658-06Ramipril30 in 1 BOTTLECAPSULE308
65841-658-16Ramipril90 in 1 BOTTLECAPSULE908
65841-658-30Ramipril10 in 1 CARTONCAPSULE108
65841-658-30Ramipril10 in 1 BLISTER PACKCAPSULE108

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RAMIPRILACTIVE INGREDIENTL35JN3I7SJRAMIPRIL CAPSULE [CADILA HEALTHCARE LIMITED]1
RAMIPRILACTIVE MOIETYL35JN3I7SJRAMIPRIL CAPSULE [CADILA HEALTHCARE LIMITED]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHRAMIPRIL CAPSULE [CADILA HEALTHCARE LIMITED]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRAMIPRIL CAPSULE [CADILA HEALTHCARE LIMITED]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRAMIPRIL CAPSULE [CADILA HEALTHCARE LIMITED]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARAMIPRIL CAPSULE [CADILA HEALTHCARE LIMITED]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MRAMIPRIL CAPSULE [CADILA HEALTHCARE LIMITED]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RAMIPRIL CAPSULE [CADILA HEALTHCARE LIMITED]1
GELATININACTIVE INGREDIENT2G86QN327LRAMIPRIL CAPSULE [CADILA HEALTHCARE LIMITED]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJRAMIPRIL CAPSULE [CADILA HEALTHCARE LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRAMIPRIL CAPSULE [CADILA HEALTHCARE LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-658RAMIPRIL CAPSULE [ZYDUS LIFESCIENCES LIMITED]8Current NDC, Legacy NDC, 6 package rows20241207_496b346b-ca79-4483-a950-bed9464e6a9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
845488ramipril 1.25 MG Oral CapsulePSN496b346b-ca79-4483-a950-bed9464e6a9d8
261962ramipril 10 MG Oral CapsulePSN496b346b-ca79-4483-a950-bed9464e6a9d8
198188ramipril 2.5 MG Oral CapsulePSN496b346b-ca79-4483-a950-bed9464e6a9d8
198189ramipril 5 MG Oral CapsulePSN496b346b-ca79-4483-a950-bed9464e6a9d8
845488ramipril 1.25 MG Oral CapsuleSCD496b346b-ca79-4483-a950-bed9464e6a9d8
261962ramipril 10 MG Oral CapsuleSCD496b346b-ca79-4483-a950-bed9464e6a9d8
198188ramipril 2.5 MG Oral CapsuleSCD496b346b-ca79-4483-a950-bed9464e6a9d8
198189ramipril 5 MG Oral CapsuleSCD496b346b-ca79-4483-a950-bed9464e6a9d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-658-0165841065801100 CAPSULE in 1 BOTTLE (65841-658-01) 100 capsule2010-11-200000-00-00NoNoCurrent
65841-658-0565841065805500 CAPSULE in 1 BOTTLE (65841-658-05) 500 capsule2010-11-200000-00-00NoNoCurrent
65841-658-066584106580630 CAPSULE in 1 BOTTLE (65841-658-06) 30 capsule2010-11-200000-00-00NoNoCurrent
65841-658-166584106581690 CAPSULE in 1 BOTTLE (65841-658-16) 90 capsule2010-11-200000-00-00NoNoCurrent
65841-658-306584106583010 BLISTER PACK in 1 CARTON (65841-658-30) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2010-11-200000-00-00NoNoCurrent