AMINOCAPROIC ACID

Product NDC
0404-9812
11-digit product format
004049812
Labeler code
0404
Product ID
0404-9812_62e82905-3810-472f-b7fd-ba45f1b2b443
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMINOCAPROIC ACID
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA070010
Marketing category
ANDA
Marketing start
2021-10-26
Substance
AMINOCAPROIC ACID
Active strength
250 mg/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 ACID250 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU6F3787206
Rxcui1718760

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
0404-9812-20AMINOCAPROIC ACID20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION205
0404-9812-20AMINOCAPROIC ACID1 in 1 BAGINJECTION, SOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9812AMINOCAPROIC ACID INJECTION, SOLUTION [HENRY SCHEIN, INC.]4Current NDC, Legacy NDC, 2 package rows20241022_5ff09f58-c225-4792-9f1e-9d2b7a413521.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718760aminocaproic acid 5 GM in 20 ML InjectionPSN5ff09f58-c225-4792-9f1e-9d2b7a4135215
171876020 ML 6-aminocaproic acid 250 MG/ML InjectionSCD5ff09f58-c225-4792-9f1e-9d2b7a4135215
1718760aminocaproic acid 5 GM per 20 ML InjectionSY5ff09f58-c225-4792-9f1e-9d2b7a4135215

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9812-20004049812201 VIAL, SINGLE-DOSE in 1 BAG (0404-9812-20) / 20 mL in 1 VIAL, SINGLE-DOSE2021-10-260000-00-00NoNoCurrent