AMINOCAPROIC ACID

Product NDC
31722-035
11-digit product format
317220035
Labeler code
31722
Product ID
31722-035_ed1784ab-0920-349b-e053-2995a90a3172
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aminocaproic acid
Dosage form
SOLUTION
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA216464
Marketing category
ANDA
Marketing start
2022-11-04
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
31722-035-23AMINOCAPROIC ACID236.5 mL in 1 BOTTLE, PLASTICSOLUTION236.51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-035-23ML - Milliliter31722-035c7d0db22-864f-4f2a-ad62-bc40e61c18c312023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-035AMINOCAPROIC ACID SOLUTION [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 1 package rows20221111_89aa9680-d06c-4b5b-8908-c38a08e6466a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582299aminocaproic acid 0.25 GM/mL Oral SolutionPSN89aa9680-d06c-4b5b-8908-c38a08e6466a1
5822996-aminocaproic acid 250 MG/ML Oral SolutionSCD89aa9680-d06c-4b5b-8908-c38a08e6466a1
5822996-aminocaproic acid 0.25 GM per ML Oral SyrupSY89aa9680-d06c-4b5b-8908-c38a08e6466a1
5822996-aminocaproic acid 1.25 GM per 5 ML Oral SyrupSY89aa9680-d06c-4b5b-8908-c38a08e6466a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-035-2331722003523236.5 mL in 1 BOTTLE, PLASTIC (31722-035-23) 236.5 ml2022-11-040000-00-00NoNoCurrent