Aminocaproic Acid

Product NDC
69680-116
11-digit product format
696800116
Labeler code
69680
Product ID
69680-116_236ce9f5-3f2f-438f-a82d-04fc57314bf7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminocaproic Acid
Dosage form
TABLET
Route
ORAL
Labeler
Vitruvias Therapeutics
Application
ANDA209060
Marketing category
ANDA
Marketing start
2018-12-03
Substance
AMINOCAPROIC ACID
Active strength
1000 mg/1
Pharmacologic classes
Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aminocaproic Acid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMINOCAPROIC ACID1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU6F3787206
Rxcui197351, 476271

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83904ae6-37b6-4aa3-b6c9-663bc8d6ab8dProduct name920250103
e89c33e6-9224-49b0-4d80-05239f586f24Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69680-116-00Aminocaproic Acid100 in 1 BOTTLETABLET1003
69680-116-30Aminocaproic Acid30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69680-116-30EA - Each69680-1161548e6c9-bc4a-430c-a0db-5ffae9957a4f12019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69680-116AMINOCAPROIC ACID TABLET [VITRUVIAS THERAPEUTICS]3Current NDC, Legacy NDC, 2 package rows20210317_555a0910-dbeb-4643-8b3a-c9fe9b803b3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476271aminocaproic acid 1000 MG Oral TabletPSN555a0910-dbeb-4643-8b3a-c9fe9b803b3c3
197351aminocaproic acid 500 MG Oral TabletPSN555a0910-dbeb-4643-8b3a-c9fe9b803b3c3
4762716-aminocaproic acid 1000 MG Oral TabletSCD555a0910-dbeb-4643-8b3a-c9fe9b803b3c3
1973516-aminocaproic acid 500 MG Oral TabletSCD555a0910-dbeb-4643-8b3a-c9fe9b803b3c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69680-116-0069680011600100 TABLET in 1 BOTTLE (69680-116-00) 100 tablet2018-12-030000-00-00NoNoCurrent
69680-116-306968001163030 TABLET in 1 BOTTLE (69680-116-30) 30 tablet2018-12-030000-00-00NoNoCurrent