Aminocaproic acid

Product NDC
52817-815
11-digit product format
528170815
Labeler code
52817
Product ID
52817-815_edabc3ff-6801-0067-e053-2a95a90ac024
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminocaproic Acid
Dosage form
SOLUTION
Route
ORAL
Labeler
TruPharma LLC
Application
ANDA212494
Marketing category
ANDA
Marketing start
2020-09-25
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
52817-815-08Aminocaproic acid236.5 mL in 1 BOTTLE, PLASTICSOLUTION236.54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-815AMINOCAPROIC ACID SOLUTION [TRUPHARMA LLC]4Current NDC, Legacy NDC, 1 package rows20221118_afffd309-3819-07c6-e053-2995a90a948b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582299aminocaproic acid 0.25 GM/mL Oral SolutionPSNafffd309-3819-07c6-e053-2995a90a948b4
5822996-aminocaproic acid 250 MG/ML Oral SolutionSCDafffd309-3819-07c6-e053-2995a90a948b4
5822996-aminocaproic acid 0.25 GM per ML Oral SyrupSYafffd309-3819-07c6-e053-2995a90a948b4
5822996-aminocaproic acid 1.25 GM per 5 ML Oral SyrupSYafffd309-3819-07c6-e053-2995a90a948b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-815-0852817081508236.5 mL in 1 BOTTLE, PLASTIC (52817-815-08) 236.5 ml2020-09-250000-00-00NoNoCurrent