Aminocaproic acid

Product NDC
69238-1596
11-digit product format
692381596
Labeler code
69238
Product ID
69238-1596_2b9785d5-ea90-465b-a9f5-2c70e578799a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminocaproic acid
Dosage form
SOLUTION
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA212780
Marketing category
ANDA
Marketing start
2019-08-23
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
e89c33e6-9224-49b0-4d80-05239f586f24Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1596-3Aminocaproic acid5 mL in 1 CUP, UNIT-DOSESOLUTION513
69238-1596-4Aminocaproic acid10 in 1 TRAYSOLUTION1013
69238-1596-8Aminocaproic acid236.5 mL in 1 BOTTLE, PLASTICSOLUTION236.513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1596AMINOCAPROIC ACID SOLUTION [AMNEAL PHARMACEUTICALS NY LLC]13Current NDC, Legacy NDC, 3 package rows20230505_65efb08a-c1ae-4bb7-a8a2-b7ae26485567.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582299aminocaproic acid 0.25 GM/mL Oral SolutionPSN65efb08a-c1ae-4bb7-a8a2-b7ae2648556713
5822996-aminocaproic acid 250 MG/ML Oral SolutionSCD65efb08a-c1ae-4bb7-a8a2-b7ae2648556713
5822996-aminocaproic acid 0.25 GM per ML Oral SyrupSY65efb08a-c1ae-4bb7-a8a2-b7ae2648556713
5822996-aminocaproic acid 1.25 GM per 5 ML Oral SyrupSY65efb08a-c1ae-4bb7-a8a2-b7ae2648556713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1596-3692381596035 mL in 1 CUP, UNIT-DOSE5 mlHistorical
69238-1596-46923815960410 CUP, UNIT-DOSE in 1 TRAY (69238-1596-4) / 5 mL in 1 CUP, UNIT-DOSE (69238-1596-3) 2019-08-230000-00-00NoNoCurrent
69238-1596-869238159608236.5 mL in 1 BOTTLE, PLASTIC (69238-1596-8) 236.5 ml2019-08-230000-00-00NoNoCurrent