Aminocaproic acid

Product NDC
0904-7165
11-digit product format
009047165
Labeler code
0904
Product ID
0904-7165_78c15c64-2046-4fa2-a82e-a27879403756
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminocaproic acid
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
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
0904-7165-07Aminocaproic acid30 in 1 CARTONTABLET303
0904-7165-07Aminocaproic acid1 in 1 BLISTER PACKTABLET13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7165-07EA - Each0904-7165e3fc1df0-1a61-433f-94d1-c68b5fcff4aa12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7165AMINOCAPROIC ACID TABLET [MAJOR PHARMACEUTICALS]3Current NDC, Legacy NDC, 2 package rows20250402_2612ee97-1723-40f2-99e6-3a736f63200f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
0904-7165-070090471650730 BLISTER PACK in 1 CARTON (0904-7165-07) / 1 TABLET in 1 BLISTER PACK30 blister pack2019-11-300000-00-00NoNoCurrent