FDA.reportPublic FDA data

Ramipril

Product NDC
70518-3038
11-digit product format
705183038
Labeler code
70518
Product ID
70518-3038_4b0776a8-f747-5724-e063-6294a90a3623
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA091604
Marketing category
ANDA
Marketing start
2021-03-03
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
2027-12-31
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
RAMIPRIL10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL35JN3I7SJ
Rxcui261962

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9a7d2f1c-330a-4830-b88b-315f5c1bab6bProduct name120151208
c76eceed-99b6-9572-9f36-9ac63b4b3ce4Product name220141218

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3038-02023-03-15C16284748780-1f386c649-ee39-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RAMIPRIL CAPSULES safely and effectively. See full prescribing information for RAMIPRIL CAPSULES. RAMIPRIL capsules, for oral use Initial U.S. Approval: 1991
70518-3038-02023-01-30C16284748780-1f386c649-ee39-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RAMIPRIL CAPSULES safely and effectively. See full prescribing information for RAMIPRIL CAPSULES. RAMIPRIL capsules, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3038-0Ramipril90 in 1 BOTTLE, PLASTICCAPSULE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3038RAMIPRIL CAPSULE [REMEDYREPACK INC.]4Current NDC, Legacy NDC, 1 package rows20250409_394a49a8-81bb-43ba-8d6a-fa6fa5030587.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
261962ramipril 10 MG Oral CapsulePSN394a49a8-81bb-43ba-8d6a-fa6fa50305876
261962ramipril 10 MG Oral CapsuleSCD394a49a8-81bb-43ba-8d6a-fa6fa50305876

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3038-07051830380090 CAPSULE in 1 BOTTLE, PLASTIC (70518-3038-0) 90 capsule2021-03-030000-00-00NoNoCurrent