FDA.reportPublic FDA data

Aminocaproic Acid

Product NDC
0409-4346
11-digit product format
004094346
Labeler code
0409
Product ID
0409-4346_eddf1507-1869-4ac6-9751-4cb12bdce2c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMINOCAPROIC ACID
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA070010
Marketing category
ANDA
Marketing start
2010-05-12
Substance
AMINOCAPROIC ACID
Active strength
250 mg/mL
Pharmacologic classes
Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aminocaproic Acid
Listing expiration
2027-12-31

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
0409-4346-16Aminocaproic Acid20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2020
0409-4346-73Aminocaproic Acid25 in 1 TRAYINJECTION, SOLUTION2520

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4346-09ML - Milliliter0409-4346ae91d070-e7bc-486e-9ac8-05a8cf09bf2d12015-06-09
0409-4346-10ML - Milliliter0409-434657d92356-25bb-40de-96fb-40f23529f35c12015-05-05
0409-4346-16ML - Milliliter0409-4346a8adcb6f-ba9e-4a09-835c-5bc01879ca2712018-07-03
0409-4346-73ML - Milliliter0409-434654a48348-f511-4a27-80d1-23d3955ec53712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMINOCAPROIC ACIDACTIVE INGREDIENTU6F3787206AMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.]11
AMINOCAPROIC ACIDACTIVE MOIETYU6F3787206AMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.]11
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBAMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.]11
WATERINACTIVE INGREDIENT059QF0KO0RAMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4346AMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.]18Current NDC, Legacy NDC, 2 package rows20241210_1c5bc1dd-e9ec-44c1-9281-67ad482315d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718760aminocaproic acid 5 GM in 20 ML InjectionPSN1c5bc1dd-e9ec-44c1-9281-67ad482315d920
171876020 ML 6-aminocaproic acid 250 MG/ML InjectionSCD1c5bc1dd-e9ec-44c1-9281-67ad482315d920
1718760aminocaproic acid 5 GM per 20 ML InjectionSY1c5bc1dd-e9ec-44c1-9281-67ad482315d920
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
1718760aminocaproic acid 5 GM in 20 ML InjectionPSN4629d585-134b-a479-e063-6294a90a34321
171876020 ML 6-aminocaproic acid 250 MG/ML InjectionSCD4629d585-134b-a479-e063-6294a90a34321
1718760aminocaproic acid 5 GM per 20 ML InjectionSY4629d585-134b-a479-e063-6294a90a34321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-4346-160040943461620 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
0409-4346-730040943467325 VIAL, SINGLE-DOSE in 1 TRAY (0409-4346-73) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-4346-16) 2010-05-120000-00-00NoNoCurrent