Ramipril

Product NDC
68382-146
11-digit product format
683820146
Labeler code
68382
Product ID
68382-146_f36e6ac7-0cfb-4450-a2f2-84064a9c7d3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA078832
Marketing category
ANDA
Marketing start
2010-11-20
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
2026-12-31
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
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
68382-146-01Ramipril100 in 1 BOTTLECAPSULE10016
68382-146-05Ramipril500 in 1 BOTTLECAPSULE50016
68382-146-06Ramipril30 in 1 BOTTLECAPSULE3016
68382-146-16Ramipril90 in 1 BOTTLECAPSULE9016
68382-146-30Ramipril1 in 1 BLISTER PACKCAPSULE116
68382-146-77Ramipril100 in 1 CARTONCAPSULE10016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-146-01EA - Each68382-14645ef4e54-9fc4-455b-b6d4-71f4ea7d6f2312012-07-24
68382-146-05EA - Each68382-146096dc721-b00c-4c8c-8489-5a82e485169012012-07-24
68382-146-06EA - Each68382-14637e39f9f-ccda-4ff1-bff2-c9490dc5f55612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RAMIPRILACTIVE INGREDIENTL35JN3I7SJRAMIPRIL CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]9
RAMIPRILATACTIVE MOIETY6N5U4QFC3GRAMIPRIL CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]9
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHRAMIPRIL CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]9
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRAMIPRIL CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRAMIPRIL CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARAMIPRIL CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]9
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MRAMIPRIL CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RAMIPRIL CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]9
GELATININACTIVE INGREDIENT2G86QN327LRAMIPRIL CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]9
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJRAMIPRIL CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRAMIPRIL CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-146RAMIPRIL CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]16Current NDC, Legacy NDC, 6 package rows20231110_055bb582-67cd-425a-8823-d543c14305ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
845488ramipril 1.25 MG Oral CapsulePSN055bb582-67cd-425a-8823-d543c14305ce16
261962ramipril 10 MG Oral CapsulePSN055bb582-67cd-425a-8823-d543c14305ce16
198188ramipril 2.5 MG Oral CapsulePSN055bb582-67cd-425a-8823-d543c14305ce16
198189ramipril 5 MG Oral CapsulePSN055bb582-67cd-425a-8823-d543c14305ce16
845488ramipril 1.25 MG Oral CapsuleSCD055bb582-67cd-425a-8823-d543c14305ce16
261962ramipril 10 MG Oral CapsuleSCD055bb582-67cd-425a-8823-d543c14305ce16
198188ramipril 2.5 MG Oral CapsuleSCD055bb582-67cd-425a-8823-d543c14305ce16
198189ramipril 5 MG Oral CapsuleSCD055bb582-67cd-425a-8823-d543c14305ce16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-146-0168382014601100 CAPSULE in 1 BOTTLE (68382-146-01) 100 capsule2010-11-200000-00-00NoNoCurrent
68382-146-0568382014605500 CAPSULE in 1 BOTTLE (68382-146-05) 500 capsule2010-11-200000-00-00NoNoCurrent
68382-146-066838201460630 CAPSULE in 1 BOTTLE (68382-146-06) 30 capsule2010-11-200000-00-00NoNoCurrent
68382-146-166838201461690 CAPSULE in 1 BOTTLE (68382-146-16) 90 capsule2010-11-200000-00-00NoNoCurrent
68382-146-30683820146301 in 1 BLISTER PACKHistorical
68382-146-7768382014677100 BLISTER PACK in 1 CARTON (68382-146-77) / 1 CAPSULE in 1 BLISTER PACK (68382-146-30) 100 blister pack2010-11-200000-00-00NoNoCurrent