Aminocaproic Acid

Product NDC
13925-530
11-digit product format
139250530
Labeler code
13925
Product ID
13925-530_af05c8f6-55a5-70a5-e053-2995a90acfd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminocaproic Acid
Dosage form
TABLET
Route
ORAL
Labeler
Seton Pharmaceuticals, LLC
Application
ANDA213944
Marketing category
ANDA
Marketing start
2021-05-11
Marketing end
0000-00-00
Substance
AMINOCAPROIC ACID
Active strength
500 mg/1
Pharmacologic classes
Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83904ae6-37b6-4aa3-b6c9-663bc8d6ab8dProduct name920250103
e89c33e6-9224-49b0-4d80-05239f586f24Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13925-530-302022-01-28C16284748780-1d6a99b39-7b3f-a426-e053-dadaa90af4c2Aminocaproic Acid Tablets, USP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13925-530AMINOCAPROIC ACID TABLET [SETON PHARMACEUTICALS, LLC]4Legacy NDC20220916_d947ab60-353e-48e0-848b-015ac7a7f8d4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13925-530-301392505303030 TABLET in 1 BOTTLE, PLASTIC (13925-530-30) 30 tablet2021-05-110000-00-00NoNoCurrent