Aminocaproic Acid

Product NDC
71921-175
11-digit product format
719210175
Labeler code
71921
Product ID
71921-175_828568a7-1808-4330-b466-01889b2311a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminocaproic Acid
Dosage form
SOLUTION
Route
ORAL
Labeler
Florida Pharmaceutical Products, LLC
Application
ANDA215510
Marketing category
ANDA
Marketing start
2025-12-20
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
71921-175-08Aminocaproic Acid236.5 mL in 1 BOTTLESOLUTION236.51

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582299aminocaproic acid 0.25 GM/mL Oral SolutionPSN828568a7-1808-4330-b466-01889b2311a21
5822996-aminocaproic acid 250 MG/ML Oral SolutionSCD828568a7-1808-4330-b466-01889b2311a21
5822996-aminocaproic acid 0.25 GM per ML Oral SyrupSY828568a7-1808-4330-b466-01889b2311a21
5822996-aminocaproic acid 1.25 GM per 5 ML Oral SyrupSY828568a7-1808-4330-b466-01889b2311a21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71921-175-0871921017508236.5 mL in 1 BOTTLE (71921-175-08) 236.5 ml2025-12-20NoNoCurrent