Aminocaproic acid

Product NDC
54288-151
11-digit product format
542880151
Labeler code
54288
Product ID
54288-151_f8d071d1-03b0-4b2b-b766-9304fd9834fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminocaproic acid
Dosage form
SOLUTION
Route
ORAL
Labeler
BPI LABS LLC
Application
ANDA213825
Marketing category
ANDA
Marketing start
2022-05-16
Substance
AMINOCAPROIC ACID
Active strength
.25 g/mL
Pharmacologic classes
Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aminocaproic acid
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54288-151-01Aminocaproic acid236.5 mL in 1 BOTTLE, PLASTICSOLUTION236.57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54288-151AMINOCAPROIC ACID SOLUTION [BPI LABS LLC]5Current NDC, Legacy NDC, 1 package rows20250213_cfa601c4-b649-417e-a301-b246f080f1eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582299aminocaproic acid 0.25 GM/mL Oral SolutionPSNcfa601c4-b649-417e-a301-b246f080f1eb7
5822996-aminocaproic acid 250 MG/ML Oral SolutionSCDcfa601c4-b649-417e-a301-b246f080f1eb7
5822996-aminocaproic acid 0.25 GM per ML Oral SyrupSYcfa601c4-b649-417e-a301-b246f080f1eb7
5822996-aminocaproic acid 1.25 GM per 5 ML Oral SyrupSYcfa601c4-b649-417e-a301-b246f080f1eb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54288-151-0154288015101236.5 mL in 1 BOTTLE, PLASTIC (54288-151-01) 236.5 ml2022-05-160000-00-00NoNoCurrent