Aminocaproic Acid

Product NDC
69680-114
11-digit product format
696800114
Labeler code
69680
Product ID
69680-114_bd7708b6-f22e-490e-a124-47dd674d7c8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminocaproic Acid
Dosage form
SOLUTION
Route
ORAL
Labeler
Vitruvias Therapeutics
Application
ANDA213213
Marketing category
ANDA
Marketing start
2024-07-19
Substance
AMINOCAPROIC ACID
Active strength
.25 g/mL
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 ACID.25 g/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU6F3787206
Rxcui582299

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
69680-114-08Aminocaproic Acid236.5 mL in 1 BOTTLESOLUTION236.57

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69680-114-08ML - Milliliter69680-1142ec6b947-1b5d-4deb-ad72-68bc9994115412024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69680-114AMINOCAPROIC ACID SOLUTION [VITRUVIAS THERAPEUTICS]7Current NDC, 1 package rows20240720_d9f615a0-119c-4553-93a7-b30025b5fe14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582299aminocaproic acid 0.25 GM/mL Oral SolutionPSNd9f615a0-119c-4553-93a7-b30025b5fe147
5822996-aminocaproic acid 250 MG/ML Oral SolutionSCDd9f615a0-119c-4553-93a7-b30025b5fe147
5822996-aminocaproic acid 0.25 GM per ML Oral SyrupSYd9f615a0-119c-4553-93a7-b30025b5fe147
5822996-aminocaproic acid 1.25 GM per 5 ML Oral SyrupSYd9f615a0-119c-4553-93a7-b30025b5fe147

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69680-114-0869680011408236.5 mL in 1 BOTTLE (69680-114-08) 236.5 ml2024-07-19NoNoHistorical