FDA.reportPublic FDA data

Aminocaproic Acid

Product NDC
60687-739
11-digit product format
606870739
Labeler code
60687
Product ID
60687-739_522e200a-159f-381b-e063-6394a90ada80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminocaproic Acid
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA209060
Marketing category
ANDA
Marketing start
2023-03-10
Substance
AMINOCAPROIC ACID
Active strength
500 mg/1
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 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
60687-739-25Aminocaproic Acid30 in 1 CARTONTABLET304
60687-739-95Aminocaproic Acid1 in 1 BLISTER PACKTABLET14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-739-25EA - Each60687-739794e967b-e65e-4083-8923-d9623061338712023-04-07
60687-739-95EA - Each60687-7395c950df1-b9ff-46a3-bfb9-f6e6ca8674cb12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-739AMINOCAPROIC ACID TABLET [AMERICAN HEALTH PACKAGING]2Current NDC, 2 package rows20241024_4c2612ab-86a4-4c54-a5c0-e837f755965f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197351aminocaproic acid 500 MG Oral TabletPSN4c2612ab-86a4-4c54-a5c0-e837f755965f4
1973516-aminocaproic acid 500 MG Oral TabletSCD4c2612ab-86a4-4c54-a5c0-e837f755965f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-739-256068707392530 BLISTER PACK in 1 CARTON (60687-739-25) / 1 TABLET in 1 BLISTER PACK (60687-739-95) 30 blister pack2023-03-10NoNoHistorical
60687-739-95606870739951 in 1 BLISTER PACKHistorical