FDA.reportPublic FDA data

NDC 0069-0195-01 - Fragmin

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
0069-0195
Requested NDC
0069-0195-01
Package NDCs from labels
0069-0195-01, 0069-0195-02
Manufacturer
Pfizer Laboratories Div Pfizer Inc | Pfizer Manufacturing Belgium NV | Pfizer Health AB
Effective date
2025-09-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fragmin - Pfizer Laboratories Div Pfizer Inc | Pfizer Manufacturing Belgium NV | Pfizer Health ABPfizer Laboratories Div Pfizer Inc | Pfizer Manufacturing Belgium NV | Pfizer Health AB2025-09-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-0195-01Fragmin0.2 mL in 1 SYRINGEINJECTION0.227
0069-0195-02Fragmin10 in 1 CARTONINJECTION1027

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0195FRAGMIN (DALTEPARIN SODIUM) INJECTION [PFIZER LABORATORIES DIV PFIZER INC]26Current NDC, Legacy NDC, 2 package rows20241114_23527b8b-9b28-4e6d-9751-33b143975ac7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0195-01ML - Milliliter0069-0195539a359e-5782-46bf-82c7-39a59d28b15a12015-07-20
0069-0195-02ML - Milliliter0069-01954eb3acc3-2f77-4641-8b27-dfecbca0cfa612015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DALTEPARIN SODIUMACTIVE INGREDIENT12M44VTJ7BFRAGMIN (DALTEPARIN SODIUM) INJECTION [PFIZER LABORATORIES DIV PFIZER INC]4
DALTEPARINACTIVE MOIETYS79O08V79FFRAGMIN (DALTEPARIN SODIUM) INJECTION [PFIZER LABORATORIES DIV PFIZER INC]4
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHFRAGMIN (DALTEPARIN SODIUM) INJECTION [PFIZER LABORATORIES DIV PFIZER INC]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFRAGMIN (DALTEPARIN SODIUM) INJECTION [PFIZER LABORATORIES DIV PFIZER INC]4
WATERINACTIVE INGREDIENT059QF0KO0RFRAGMIN (DALTEPARIN SODIUM) INJECTION [PFIZER LABORATORIES DIV PFIZER INC]4

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 20 of 53 · 1,043 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tri-Relief AntifungalSODIUM CHLORIDE, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGForces of Nature6fe97b54-8aa3-4d86-9055-0629589a416b2025-10-06WarningsExact identifier
unii: 451W47IQ8X
VirexADENOVIREN NOSODE, ASCLEPIAS TUBEROSA, CALCAREA ARSENICICA, CAMPHORA, COXSACKIE A2 NOSODE, COXSACKIE A3 NOSODE, COXSACKIE A4 NOSODE, COXSACKIE A5 NOSODE, COXSACKIE A7 NOSODE, COXSACKIE B1 NOSODE, COXSACKIE B3 NOSODE, COXSACKIE B4 NOSODE, COXSACKIE B5 NOSODE, CYTOMEGALOVIRUS NOSODE, ECHINACEA PURPUREA, EPSTEIN-BARR VIRUS NOSODE, EUPHRASIA OFFICINALIS, INFLUENZINUM, LAC VACCINUM, MORBILLINUM, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, THUJA OCCIDENTALIS, TRIFOLIUM PRATENSE, VARIOLINUMNutritional Specialties, Inc.4baa5c95-79a6-4ae8-a8c4-1edbf308f92c2025-10-03WarningsExact identifier
unii: 451W47IQ8X
FragminDALTEPARIN SODIUMPfizer Laboratories Div Pfizer Inc23527b8b-9b28-4e6d-9751-33b143975ac72025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA020287
ndc (package): 0069-0195-01
ndc (package): 0069-0220-02
ndc (package): 0069-0223-02
ndc (package): 0069-0196-02
ndc (package): 0069-0206-02
ndc (package): 0069-0228-01
ndc (package): 0069-0217-02
ndc (package): 0069-0253-10
ndc (package): 0069-0223-01
ndc (package): 0069-0220-01
ndc (package): 0069-0217-01
ndc (package): 0069-0253-01
ndc (package): 0069-0196-01
ndc (package): 0069-0232-01
ndc (package): 0069-0228-02
ndc (package): 0069-0195-02
ndc (package): 0069-0206-01
ndc (product): 0069-0196
ndc (product): 0069-0195
ndc (product): 0069-0206
ndc (product): 0069-0220
ndc (product): 0069-0223
ndc (product): 0069-0232
ndc (product): 0069-0217
ndc (product): 0069-0228
ndc (product): 0069-0253
ndc11 (package): 00069019501
rxcui: 978744
rxcui: 978747
rxcui: 978741
rxcui: 978727
rxcui: 978746
rxcui: 978777
rxcui: 978778
rxcui: 978740
rxcui: 2618839
rxcui: 978737
rxcui: 978735
rxcui: 978745
rxcui: 978755
rxcui: 2618842
rxcui: 978736
rxcui: 978725
rxcui: 978757
rxcui: 978733
spl id: af340f13-7954-4974-845d-ae55e0b56512
spl set id: 23527b8b-9b28-4e6d-9751-33b143975ac7
unii: 12M44VTJ7B
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Jet LagECHINACEA, ALUMINA, ARALIA QUINQUEFOLIA, ARGENTUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IODIUM, KALI CARBONICUM, KALI IODATUM, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, THYROIDINUM.Newton Laboratories, Inc.9c21c935-4ebc-1efd-e053-2995a90aa1562025-09-18WarningsExact identifier
unii: 451W47IQ8X
GAVILYTE-NPOLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATELupin Pharmaceuticals,Inc.27195187-75a3-431f-90d9-84da1b94e8492025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GaviLyte - C TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACKLupin Pharmaceuticals,Inc.a8b15625-ca7c-4d57-9f36-3ac2a6d136652025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GAVILYTE G TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESLupin Pharmaceuticals,Inc.3978822b-6473-4072-9f80-20ceb9bea3552025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltd9083a01b-2fbe-4e04-9eec-bf4f65950ec72025-09-09WarningsExact identifier
unii: 451W47IQ8X
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM ,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltdc14c79ab-85bb-45f2-83d1-1d9c298ffdfd2025-09-08WarningsExact identifier
unii: 451W47IQ8X
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Polyethylene Glycol 3350 and electrolytes - UnflavoredPOLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVOREDStrides Pharma Science Limited48c741a9-9039-4fdb-a875-86d4ea9682822025-09-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - UnflavoredPOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE - UNFLAVOREDStrides Pharma Science Limited37c111ec-5b62-42b9-bbb2-3b0c530e34c92025-09-01Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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