AMINOCAPROIC ACID

Product NDC
70377-104
11-digit product format
703770104
Labeler code
70377
Product ID
70377-104_4c94e9c7-476c-8256-83cf-723ff8e5107b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMINOCAPROIC ACID
Dosage form
SOLUTION
Route
ORAL
Labeler
Biocon Pharma Inc.
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
e89c33e6-9224-49b0-4d80-05239f586f24Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70377-104-11AMINOCAPROIC ACID236.5 mL in 1 BOTTLESOLUTION236.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70377-104AMINOCAPROIC ACID SOLUTION [BIOCON PHARMA INC.]1Current NDC, Legacy NDC, 1 package rows20220831_c3cadb3a-4f63-06ee-0dd2-6828dbc1fffa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582299aminocaproic acid 0.25 GM/mL Oral SolutionPSNc3cadb3a-4f63-06ee-0dd2-6828dbc1fffa1
5822996-aminocaproic acid 250 MG/ML Oral SolutionSCDc3cadb3a-4f63-06ee-0dd2-6828dbc1fffa1
5822996-aminocaproic acid 0.25 GM per ML Oral SyrupSYc3cadb3a-4f63-06ee-0dd2-6828dbc1fffa1
5822996-aminocaproic acid 1.25 GM per 5 ML Oral SyrupSYc3cadb3a-4f63-06ee-0dd2-6828dbc1fffa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70377-104-1170377010411236.5 mL in 1 BOTTLE (70377-104-11) 236.5 ml2021-03-180000-00-00NoNoCurrent