AMINOCAPROIC ACID

Product NDC
80005-130
11-digit product format
800050130
Labeler code
80005
Product ID
80005-130_acb7cc2c-2aea-4c13-96b5-e2d1840ea1d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMINOCAPROIC ACID
Dosage form
SOLUTION
Route
ORAL
Labeler
Carnegie Pharmaceuticals, LLC
Application
ANDA214140
Marketing category
ANDA
Marketing start
2021-03-18
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
e89c33e6-9224-49b0-4d80-05239f586f24Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80005-130-222024-03-04C16284748780-11030e365-1c4f-111a-e063-dadaa90a10e2Aminocaproic Acid Oral Solution, USP Rx only
80005-130-222024-01-30C16284748780-11030e365-1c4f-111a-e063-dadaa90a10e2Aminocaproic Acid Oral Solution, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80005-130-22AMINOCAPROIC ACID236.5 mL in 1 BOTTLESOLUTION236.53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80005-130-22ML - Milliliter80005-1301c444705-aa7a-4ea3-8f12-2e0304cc333012025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80005-130AMINOCAPROIC ACID SOLUTION [CARNEGIE PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 1 package rows20240307_0d6560a3-c67e-428e-b9b8-fab538856b41.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582299aminocaproic acid 0.25 GM/mL Oral SolutionPSNc2144bf8-1a26-4958-ba10-5358bd69cd23100
5822996-aminocaproic acid 250 MG/ML Oral SolutionSCDc2144bf8-1a26-4958-ba10-5358bd69cd23100
5822996-aminocaproic acid 0.25 GM per ML Oral SyrupSYc2144bf8-1a26-4958-ba10-5358bd69cd23100
5822996-aminocaproic acid 1.25 GM per 5 ML Oral SyrupSYc2144bf8-1a26-4958-ba10-5358bd69cd23100
582299aminocaproic acid 0.25 GM/mL Oral SolutionPSN0d6560a3-c67e-428e-b9b8-fab538856b413
5822996-aminocaproic acid 250 MG/ML Oral SolutionSCD0d6560a3-c67e-428e-b9b8-fab538856b413
5822996-aminocaproic acid 0.25 GM per ML Oral SyrupSY0d6560a3-c67e-428e-b9b8-fab538856b413
5822996-aminocaproic acid 1.25 GM per 5 ML Oral SyrupSY0d6560a3-c67e-428e-b9b8-fab538856b413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80005-130-2280005013022236.5 mL in 1 BOTTLE (80005-130-22) 236.5 ml2021-03-180000-00-00NoNoCurrent