Aminocaproic Acid

Product NDC
72572-015
11-digit product format
725720015
Labeler code
72572
Product ID
72572-015_eca54466-0ed1-4cb0-9ca4-e484706235e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminocaproic Acid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA071192
Marketing category
ANDA
Marketing start
2020-10-29
Substance
AMINOCAPROIC ACID
Active strength
250 mg/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 ACID250 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU6F3787206
Rxcui238719

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83904ae6-37b6-4aa3-b6c9-663bc8d6ab8dProduct name920250103
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
e89c33e6-9224-49b0-4d80-05239f586f24Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72572-015-01Aminocaproic Acid20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION203
72572-015-25Aminocaproic Acid25 in 1 TRAYINJECTION, SOLUTION253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-015AMINOCAPROIC ACID INJECTION, SOLUTION [CIVICA, INC.]3Current NDC, Legacy NDC, 2 package rows20201029_36283eb3-f98e-446f-ade7-ce7864cd5779.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238719aminocaproic acid 250 MG/ML Injectable SolutionPSN36283eb3-f98e-446f-ade7-ce7864cd57793
2387196-aminocaproic acid 250 MG/ML Injectable SolutionSCD36283eb3-f98e-446f-ade7-ce7864cd57793

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-015-017257200150120 mL in 1 VIAL, MULTI-DOSE20 mlHistorical
72572-015-257257200152525 VIAL, MULTI-DOSE in 1 TRAY (72572-015-25) / 20 mL in 1 VIAL, MULTI-DOSE (72572-015-01) 2020-10-290000-00-00NoNoCurrent