AMICAR

Product NDC
49411-051
11-digit product format
494110051
Labeler code
49411
Product ID
49411-051_bcb6223c-cffb-4b9f-9688-9e670d1bb21b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminocaproic Acid
Dosage form
TABLET
Route
ORAL
Labeler
Akorn Operating Company LLC
Application
NDA015197
Marketing category
NDA
Marketing start
2015-06-01
Marketing end
0000-00-00
Substance
AMINOCAPROIC ACID
Active strength
1000 mg/1
Pharmacologic classes
Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83904ae6-37b6-4aa3-b6c9-663bc8d6ab8dProduct name920250103
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
e89c33e6-9224-49b0-4d80-05239f586f24Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49411-051-30EA - Each49411-051f337820d-2ef4-4722-9a8a-dfc2a2a8b3f812015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMINOCAPROIC ACIDACTIVE INGREDIENTU6F3787206AMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]4
AMINOCAPROIC ACIDACTIVE MOIETYU6F3787206AMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EAMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]4
RASPBERRYINACTIVE INGREDIENT4N14V5R27WAMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYAMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]4
SORBITOLINACTIVE INGREDIENT506T60A25RAMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APAMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [CLOVER PHARMACEUTICALS CORP.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49411-051AMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET [AKORN OPERATING COMPANY LLC]8Legacy NDC20220701_2238c70f-b0b5-4755-896b-45b28777b217.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49411-051-304941100513030 TABLET in 1 BOTTLE, PLASTIC (49411-051-30) 30 tablet2015-06-010000-00-00NoNoCurrent