FDA.reportPublic FDA data

NDC 0409-4346-16 - Aminocaproic Acid

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0409-4346
Requested NDC
0409-4346-16
Package NDCs from labels
0409-4346-16, 0409-4346-73, 0409-4346-09, 0409-4346-10
Manufacturer
Hospira, Inc. | Pfizer Healthcare India Private Limited
Effective date
2026-04-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Aminocaproic Acid - Hospira, Inc. | Pfizer Healthcare India Private LimitedHospira, Inc. | Pfizer Healthcare India Private Limited2026-04-30HUMAN PRESCRIPTION DRUG LABEL
Aminocaproic Acid - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2025-12-17HUMAN PRESCRIPTION DRUG LABEL
AMINOCAPROIC ACID - Henry Schein, Inc.Henry Schein, Inc.2025-07-11HUMAN PRESCRIPTION DRUG LABEL
AMINOCAPROIC ACID - General Injectables and Vaccines, Inc.General Injectables and Vaccines, Inc.2022-12-06HUMAN PRESCRIPTION DRUG LABEL
AMINOCAPROIC ACID Injection, USPHospira, Inc.2020-01-14HUMAN PRESCRIPTION DRUG LABEL

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 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 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
AMINOCAPROIC ACIDACTIVE INGREDIENTU6F3787206AMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.]1
AMINOCAPROIC ACIDACTIVE MOIETYU6F3787206AMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBAMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RAMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 12 · 222 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Aminocaproic acidAMINOCAPROIC ACIDMajor Pharmaceuticals2612ee97-1723-40f2-99e6-3a736f63200f2026-08-04Warnings, Adverse reactionsExact identifier
unii: U6F3787206
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Aminocaproic acidAMINOCAPROIC ACIDAmneal Pharmaceuticals LLC4a22e559-2dac-42d7-af8d-eb0ebbc2f76d2026-07-28Warnings, Adverse reactionsExact identifier
unii: U6F3787206
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
Humalog KwikPenINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.