FDA.reportPublic FDA data

Ramipril

Product NDC
50090-5673
11-digit product format
500905673
Labeler code
50090
Product ID
50090-5673_cd5368d6-2b07-42a9-b45d-2f9868a82f59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091604
Marketing category
ANDA
Marketing start
2011-06-08
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
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
RAMIPRIL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL35JN3I7SJ
Rxcui198189

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
50090-5673-02023-02-07C16284748780-1f386c649-bd62-0266-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
50090-5673-12023-02-07C16284748780-1f386c649-bd62-0266-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
50090-5673-02023-01-30C16284748780-1f386c649-bd62-0266-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
50090-5673-12023-01-30C16284748780-1f386c649-bd62-0266-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
50090-5673-0Ramipril30 in 1 BOTTLECAPSULE307
50090-5673-1Ramipril90 in 1 BOTTLECAPSULE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5673-0EA - Each50090-5673db4f3d7c-583b-4404-8da4-1f03a24e4f4d12022-10-06
50090-5673-1EA - Each50090-567321b76c27-e274-4573-8011-11cdc34e41ed12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5673RAMIPRIL CAPSULE [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20231210_a3786664-a1b5-4914-99d6-79fb0e330e98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198189ramipril 5 MG Oral CapsulePSNa3786664-a1b5-4914-99d6-79fb0e330e987
198189ramipril 5 MG Oral CapsuleSCDa3786664-a1b5-4914-99d6-79fb0e330e987

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5673-05009056730030 CAPSULE in 1 BOTTLE (50090-5673-0) 30 capsule2021-09-160000-00-00NoNoCurrent
50090-5673-15009056730190 CAPSULE in 1 BOTTLE (50090-5673-1) 90 capsule2021-09-160000-00-00NoNoCurrent