Aminocaproic acid

Product NDC
72205-286
11-digit product format
722050286
Labeler code
72205
Product ID
72205-286_9d58cbb6-d3e8-4b56-a3f5-d2619db3b618
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminocaproic acid
Dosage form
TABLET
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA212938
Marketing category
ANDA
Marketing start
2023-09-13
Substance
AMINOCAPROIC ACID
Active strength
1000 mg/1
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 ACID1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU6F3787206
Rxcui197351, 476271

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
72205-286-30Aminocaproic acid30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-286AMINOCAPROIC ACID TABLET [NOVADOZ PHARMACEUTICALS LLC]2Current NDC, 1 package rows20230922_c5dc0c33-a0f9-43c4-9f10-3668f4361b87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476271aminocaproic acid 1000 MG Oral TabletPSNc5dc0c33-a0f9-43c4-9f10-3668f4361b872
197351aminocaproic acid 500 MG Oral TabletPSNc5dc0c33-a0f9-43c4-9f10-3668f4361b872
4762716-aminocaproic acid 1000 MG Oral TabletSCDc5dc0c33-a0f9-43c4-9f10-3668f4361b872
1973516-aminocaproic acid 500 MG Oral TabletSCDc5dc0c33-a0f9-43c4-9f10-3668f4361b872

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-286-307220502863030 TABLET in 1 BOTTLE (72205-286-30) 30 tablet2023-09-21NoNoCurrent