Aminocaproic acid

Product NDC
69238-1637
11-digit product format
692381637
Labeler code
69238
Product ID
69238-1637_6091bbf2-e45e-416d-bd4e-fc95dfeb609a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminocaproic acid
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA212492
Marketing category
ANDA
Marketing start
2019-11-30
Substance
AMINOCAPROIC ACID
Active strength
500 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 ACID500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU6F3787206
Rxcui197351

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
69238-1637-3Aminocaproic acid30 in 1 BOTTLE, PLASTICTABLET308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1637AMINOCAPROIC ACID TABLET [AMNEAL PHARMACEUTICALS NY LLC]8Current NDC, Legacy NDC, 1 package rows20231229_4a22e559-2dac-42d7-af8d-eb0ebbc2f76d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197351aminocaproic acid 500 MG Oral TabletPSN4a22e559-2dac-42d7-af8d-eb0ebbc2f76d8
1973516-aminocaproic acid 500 MG Oral TabletSCD4a22e559-2dac-42d7-af8d-eb0ebbc2f76d8
197351aminocaproic acid 500 MG Oral TabletPSN2612ee97-1723-40f2-99e6-3a736f63200f3
1973516-aminocaproic acid 500 MG Oral TabletSCD2612ee97-1723-40f2-99e6-3a736f63200f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1637-36923816370330 TABLET in 1 BOTTLE, PLASTIC (69238-1637-3) 30 tablet2019-11-300000-00-00NoNoCurrent