Aminocaproic Acid

Product NDC
59651-573
11-digit product format
596510573
Labeler code
59651
Product ID
59651-573_48c6a773-7cde-4271-876a-4570a301f43a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminocaproic Acid
Dosage form
SOLUTION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA216804
Marketing category
ANDA
Marketing start
2022-09-26
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
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
e89c33e6-9224-49b0-4d80-05239f586f24Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-573-08Aminocaproic Acid236.5 mL in 1 BOTTLESOLUTION236.51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-573-08ML - Milliliter59651-5733ae76662-7717-4f1f-86a0-69a2e2cfc54a12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-573AMINOCAPROIC ACID SOLUTION [AUROBINDO PHARMA LIMITED]1Current NDC, Legacy NDC, 1 package rows20220930_48c6a773-7cde-4271-876a-4570a301f43a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582299aminocaproic acid 0.25 GM/mL Oral SolutionPSN48c6a773-7cde-4271-876a-4570a301f43a1
5822996-aminocaproic acid 250 MG/ML Oral SolutionSCD48c6a773-7cde-4271-876a-4570a301f43a1
5822996-aminocaproic acid 0.25 GM per ML Oral SyrupSY48c6a773-7cde-4271-876a-4570a301f43a1
5822996-aminocaproic acid 1.25 GM per 5 ML Oral SyrupSY48c6a773-7cde-4271-876a-4570a301f43a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-573-0859651057308236.5 mL in 1 BOTTLE (59651-573-08) 236.5 ml2022-09-260000-00-00NoNoCurrent