FDA.reportPublic FDA data

Ramipril

Product NDC
62135-274
11-digit product format
621350274
Labeler code
62135
Product ID
62135-274_47ce17ad-f085-8ce7-e063-6294a90a7520
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
Chartwell RX, LLC.
Application
ANDA078745
Marketing category
ANDA
Marketing start
2020-08-26
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
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
62135-274-01Ramipril100 in 1 BOTTLECAPSULE1004
62135-274-05Ramipril500 in 1 BOTTLECAPSULE5004
62135-274-90Ramipril90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-274-01EA - Each62135-274cdb976dc-85ee-4905-be81-f5ea3db52a5812020-09-14
62135-274-05EA - Each62135-2742040012c-43de-49d8-aef5-81b977152a8312020-09-14
62135-274-90EA - Each62135-274804999f4-76ce-4475-8a86-82a3cc4b3a0712026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-274RAMIPRIL CAPSULE [CHARTWELL RX, LLC.]3Current NDC, Legacy NDC, 3 package rows20231104_b7e49f05-6d4f-465a-b0d7-f704466a2e52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
845488ramipril 1.25 MG Oral CapsulePSNb7e49f05-6d4f-465a-b0d7-f704466a2e524
261962ramipril 10 MG Oral CapsulePSNb7e49f05-6d4f-465a-b0d7-f704466a2e524
198188ramipril 2.5 MG Oral CapsulePSNb7e49f05-6d4f-465a-b0d7-f704466a2e524
198189ramipril 5 MG Oral CapsulePSNb7e49f05-6d4f-465a-b0d7-f704466a2e524
845488ramipril 1.25 MG Oral CapsuleSCDb7e49f05-6d4f-465a-b0d7-f704466a2e524
261962ramipril 10 MG Oral CapsuleSCDb7e49f05-6d4f-465a-b0d7-f704466a2e524
198188ramipril 2.5 MG Oral CapsuleSCDb7e49f05-6d4f-465a-b0d7-f704466a2e524
198189ramipril 5 MG Oral CapsuleSCDb7e49f05-6d4f-465a-b0d7-f704466a2e524

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-274-0162135027401100 CAPSULE in 1 BOTTLE (62135-274-01) 100 capsule2020-08-260000-00-00NoNoCurrent
62135-274-0562135027405500 CAPSULE in 1 BOTTLE (62135-274-05) 500 capsule2020-08-260000-00-00NoNoCurrent
62135-274-906213502749090 CAPSULE in 1 BOTTLE (62135-274-90) 90 capsule2026-01-02NoNoHistorical