Aminocaproic Acid

Product NDC
83745-294
11-digit product format
837450294
Labeler code
83745
Product ID
83745-294_98a1b6f4-8251-489a-94da-f98fc1d57d7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminocaproic Acid
Dosage form
SOLUTION
Route
ORAL
Labeler
Apozeal Pharmaceuticals Inc.
Application
ANDA213216
Marketing category
ANDA
Marketing start
2025-11-10
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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
e89c33e6-9224-49b0-4d80-05239f586f24Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83745-294-08Aminocaproic Acid236.5 mL in 1 BOTTLESOLUTION236.51

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582299aminocaproic acid 0.25 GM/mL Oral SolutionPSN15aa2f36-ccc6-431a-99a2-45d812ef4bbf1
5822996-aminocaproic acid 250 MG/ML Oral SolutionSCD15aa2f36-ccc6-431a-99a2-45d812ef4bbf1
5822996-aminocaproic acid 0.25 GM per ML Oral SyrupSY15aa2f36-ccc6-431a-99a2-45d812ef4bbf1
5822996-aminocaproic acid 1.25 GM per 5 ML Oral SyrupSY15aa2f36-ccc6-431a-99a2-45d812ef4bbf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83745-294-0883745029408236.5 mL in 1 BOTTLE (83745-294-08) 236.5 ml2025-11-10NoNoCurrent