Aminocaproic acid

Product NDC
72205-032
11-digit product format
722050032
Labeler code
72205
Product ID
72205-032_8a0d4fa5-8608-4e83-b5c7-d7e088d80281
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminocaproic acid
Dosage form
SOLUTION
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA215100
Marketing category
ANDA
Marketing start
2024-09-26
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
72205-032-71Aminocaproic acid236.5 mL in 1 BOTTLE, PLASTICSOLUTION236.51
72205-032-72Aminocaproic acid473 mL in 1 BOTTLE, PLASTICSOLUTION4731

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582299aminocaproic acid 0.25 GM/mL Oral SolutionPSN8a0d4fa5-8608-4e83-b5c7-d7e088d802811
5822996-aminocaproic acid 250 MG/ML Oral SolutionSCD8a0d4fa5-8608-4e83-b5c7-d7e088d802811
5822996-aminocaproic acid 0.25 GM per ML Oral SyrupSY8a0d4fa5-8608-4e83-b5c7-d7e088d802811
5822996-aminocaproic acid 1.25 GM per 5 ML Oral SyrupSY8a0d4fa5-8608-4e83-b5c7-d7e088d802811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-032-7172205003271236.5 mL in 1 BOTTLE, PLASTIC (72205-032-71) 236.5 ml2026-01-01NoNoHistorical
72205-032-7272205003272473 mL in 1 BOTTLE, PLASTIC (72205-032-72) 473 ml2026-01-01NoNoHistorical