Ramipril

Product NDC
63629-1254
11-digit product format
636291254
Labeler code
63629
Product ID
63629-1254_7493b648-14e2-4a84-b33b-ea7de6919a68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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
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
63629-1254-12020-10-12C16284748780-19d75b9d0-7e2e-f424-e053-dadaa90a57ceThese 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
63629-1254-22020-10-12C16284748780-19d75b9d0-7e2e-f424-e053-dadaa90a57ceThese 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
63629-1254-32020-10-12C16284748780-19d75b9d0-7e2e-f424-e053-dadaa90a57ceThese 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
63629-1254-42020-10-12C16284748780-19d75b9d0-7e2e-f424-e053-dadaa90a57ceThese 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
63629-1254-12020-01-31C16284748780-19d75b9d0-7e2e-f424-e053-dadaa90a57ceThese 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
63629-1254-22020-01-31C16284748780-19d75b9d0-7e2e-f424-e053-dadaa90a57ceThese 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
63629-1254-32020-01-31C16284748780-19d75b9d0-7e2e-f424-e053-dadaa90a57ceThese 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
63629-1254-42020-01-31C16284748780-19d75b9d0-7e2e-f424-e053-dadaa90a57ceThese 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
63629-1254-1Ramipril30 in 1 BOTTLECAPSULE301016
63629-1254-2Ramipril20 in 1 BOTTLECAPSULE201016
63629-1254-3Ramipril90 in 1 BOTTLECAPSULE901016
63629-1254-4Ramipril60 in 1 BOTTLECAPSULE601016
63629-1254-5Ramipril10 in 1 BOTTLECAPSULE101016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1254-1EA - Each63629-1254cd23947c-d335-48b2-b714-0310412ae33412013-02-13
63629-1254-2EA - Each63629-1254e0e2ee2a-f334-4ab3-bd99-8368716dab0c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RAMIPRILACTIVE INGREDIENTL35JN3I7SJRAMIPRIL CAPSULE [BRYANT RANCH PREPACK]1001
RAMIPRILATACTIVE MOIETY6N5U4QFC3GRAMIPRIL CAPSULE [BRYANT RANCH PREPACK]1001
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHRAMIPRIL CAPSULE [BRYANT RANCH PREPACK]1001
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRAMIPRIL CAPSULE [BRYANT RANCH PREPACK]1001
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RAMIPRIL CAPSULE [BRYANT RANCH PREPACK]1001
GELATININACTIVE INGREDIENT2G86QN327LRAMIPRIL CAPSULE [BRYANT RANCH PREPACK]1001
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRAMIPRIL CAPSULE [BRYANT RANCH PREPACK]1001
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRAMIPRIL CAPSULE [BRYANT RANCH PREPACK]1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1254RAMIPRIL CAPSULE [BRYANT RANCH PREPACK]1016Current NDC, Legacy NDC, 5 package rows20240601_245d3580-77c6-4c0f-b324-c8514b792c59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198189ramipril 5 MG Oral CapsulePSN245d3580-77c6-4c0f-b324-c8514b792c591016
198189ramipril 5 MG Oral CapsuleSCD245d3580-77c6-4c0f-b324-c8514b792c591016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1254-16362912540130 CAPSULE in 1 BOTTLE (63629-1254-1) 30 capsule2023-03-010000-00-00NoNoCurrent
63629-1254-26362912540220 CAPSULE in 1 BOTTLE (63629-1254-2) 20 capsule2023-03-010000-00-00NoNoCurrent
63629-1254-36362912540390 CAPSULE in 1 BOTTLE (63629-1254-3) 90 capsule2014-06-120000-00-00NoNoCurrent
63629-1254-46362912540460 CAPSULE in 1 BOTTLE (63629-1254-4) 60 capsule2014-06-120000-00-00NoNoCurrent
63629-1254-56362912540510 CAPSULE in 1 BOTTLE (63629-1254-5) 10 capsule2023-03-010000-00-00NoNoCurrent