FDA.reportPublic FDA data

NDC 70710-1516-2 - fondaparinux sodium

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
70710-1516
Requested NDC
70710-1516-2
Package NDCs from labels
70710-1516-2, 70710-1516-9, 70710-1516-6
Manufacturer
Zydus Pharmaceuticals (USA) Inc. | ScinoPharm Taiwan, Ltd.
Effective date
2025-10-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
fondaparinux sodium - Zydus Pharmaceuticals (USA) Inc. | ScinoPharm Taiwan, Ltd.Zydus Pharmaceuticals (USA) Inc. | ScinoPharm Taiwan, Ltd.2025-10-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1516-2fondaparinux sodium0.6 mL in 1 SYRINGEINJECTION, SOLUTION0.620
70710-1516-6fondaparinux sodium10 in 1 CARTONINJECTION, SOLUTION1020
70710-1516-9fondaparinux sodium2 in 1 CARTONINJECTION, SOLUTION220

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1516FONDAPARINUX SODIUM INJECTION, SOLUTION [ZYDUS PHARMACEUTICALS (USA) INC.]10Current NDC, Legacy NDC, 3 package rows20241106_dffbf7c9-495e-4a33-ac76-57b52f014fc2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1516-2ML - Milliliter70710-15162885df0f-9311-4b24-b27b-3234412f96eb12020-02-13
70710-1516-6ML - Milliliter70710-15165eb95a77-6bc5-498f-b573-b401ac307ec512020-02-13
70710-1516-9ML - Milliliter70710-15168b6539bc-7d17-4b20-8569-91b3f1b2675412020-02-13

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 18 of 53 · 1,052 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE AND POTASSIUM CHLORIDEICU Medical Inc.9dd1c001-73b3-41d4-9a96-61f6ad3a5dc32025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.3cfdeee0-ff14-4341-8396-b11c2a037c602025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.5f372b75-d7a4-471e-8ac6-290040fc84b02025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE AND POTASSIUM CHLORIDEICU Medical Inc.243fe8fc-996a-4855-8daf-069628e547c42025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEICU Medical Inc.d310d170-5eeb-471b-af1a-0e845001d21d2025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Family Care SalineSODIUM CHLORIDEUnited Exchange Corp.06737393-d4ae-3e7b-e063-6394a90ac19f2025-10-31WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.009bef3c-e8ac-46be-b564-a2556adf00812025-10-31Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Lactated Ringers and DextrosePOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATEICU Medical Inc.237b39fa-916e-4a54-99c8-4ae9ad54f0562025-10-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Normosol-R and DextroseDEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.ead1fca3-eff4-478f-8a8f-67510f80151a2025-10-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Normosol-RSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.0e089a44-0cee-4804-8f6f-8508508ddb5c2025-10-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Normosol-RSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.189b8ac6-e346-454f-b501-7645590ca4f82025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Cold and Cough 4 KidsONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEALHyland's Inc.e06599ca-fc94-4b2c-829e-f3d4ec866ed62025-10-29WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDECardinal Health 107, LLC97007188-43fe-416c-a87b-6ccc4d9ae2ec2025-10-29Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Potassium Chloride in Lactated Ringers and DextroseDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporation05f326e6-10e4-4ceb-8a23-f53c592f00b82025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE AND DEXTROSE MONOHYDRATEBaxter Healthcare Corporation6acc9f96-7088-45a7-b48f-1a861e3467ab2025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM LACTATE AND CALCIUM CHLORIDEBaxter Healthcare Companydad7735c-709b-40ea-ab7a-15577e24a9662025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
fondaparinux sodiumFONDAPARINUX SODIUMZydus Pharmaceuticals (USA) Inc.dffbf7c9-495e-4a33-ac76-57b52f014fc22025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208615
ndc (package): 70710-1517-6
ndc (package): 70710-1515-9
ndc (package): 70710-1517-2
ndc (package): 70710-1514-9
ndc (package): 70710-1516-6
ndc (package): 70710-1515-2
ndc (package): 70710-1515-6
ndc (package): 70710-1516-9
ndc (package): 70710-1514-6
ndc (package): 70710-1517-9
ndc (package): 70710-1516-2
ndc (package): 70710-1514-2
ndc (product): 70710-1515
ndc (product): 70710-1514
ndc (product): 70710-1517
ndc (product): 70710-1516
ndc11 (package): 70710151602
rxcui: 861356
rxcui: 861360
rxcui: 861365
rxcui: 861363
spl id: 4234bd9e-7f61-2cb0-e063-6294a90a4e14
spl set id: dffbf7c9-495e-4a33-ac76-57b52f014fc2
unii: X0Q6N9USOZ

Reported adverse events (FAERS/openFDA)#

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