FDA.reportPublic FDA data

NDC 0641-6115-01 - Oxytocin

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
0641-6115
Requested NDC
0641-6115-01
Package NDCs from labels
0641-6115-01, 0641-6115-25
Manufacturer
Hikma Pharmaceuticals USA Inc. | Gland Pharma Limited
Effective date
2019-12-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Oxytocin - Hikma Pharmaceuticals USA Inc. | Gland Pharma LimitedHikma Pharmaceuticals USA Inc. | Gland Pharma Limited2019-12-30HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0641-6115-252025-01-30C16284748780-12cef2736-7f27-d83d-e063-dadaa90ab31fOxytocin Injection, USP (synthetic)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6115-01Oxytocin10 mL in 1 VIALINJECTION103
0641-6115-25Oxytocin25 in 1 CARTONINJECTION253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6115OXYTOCIN INJECTION [HIKMA PHARMACEUTICALS USA INC.]3Legacy NDC, 2 package rows20191231_a9b62187-4141-487c-a9da-f42ad7f9b408.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6115-01ML - Milliliter0641-61155f654325-5d51-43d3-b685-4d6acf0d0ba612012-07-24
0641-6115-25ML - Milliliter0641-61151b040dc4-4b03-4b77-8542-19857f1c0ec112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYTOCINACTIVE INGREDIENT1JQS135EYNOXYTOCIN INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
OXYTOCINACTIVE MOIETY1JQS135EYNOXYTOCIN INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063POXYTOCIN INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
CHLOROBUTANOLINACTIVE INGREDIENTHM4YQM8WRCOXYTOCIN INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
WATERINACTIVE INGREDIENT059QF0KO0ROXYTOCIN INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2

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 8 of 13 · 254 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Endopan HPACETICUM ACIDUM, COLCHICUM AUTUMNALE, LACTICUM ACIDUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SYZYGIUM JAMBOLANUM, URANIUM NITRICUMEnergique, Inc.0d475595-7afe-423f-9da8-720f1513f9562024-10-24WarningsExact identifier
unii: Q40Q9N063P
Dental PainACETICUM ACIDUM, CALENDULA OFFICINALIS, ZINGIBER OFFICINALE, BRYONIA (ALBA), COFFEA TOSTA, LEDUM PALUSTRE, PHOSPHORUS, PLANTAGO MAJOR, SPIGELIA ANTHELMIA, ARNICA MONTANA, CHAMOMILLA, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, ACONITUM NAPELLUS, ANTIMONIUM CRUDUM, MEZEREUM, SEPIA, STAPHYSAGRIA, MAGNESIA PHOSPHORICADeseret Biologicals, Inc.3a117358-3c51-4870-9932-701ffe90e3f82024-10-23WarningsExact identifier
unii: Q40Q9N063P
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: Q40Q9N063P
OxytocinOXYTOCINFresenius Kabi USA, LLC6d7d1280-f286-4f39-89f3-2b96571810e62024-10-15Warnings, Adverse reactionsExact identifier
rxcui: 1791721
rxcui: 238013
unii: 1JQS135EYN
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
PitocinOXYTOCINPar Health USA, LLCdddcdcc3-cd4d-4573-98ac-9468bea23a8b2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791721
rxcui: 238013
unii: 1JQS135EYN
Acetic AcidACETIC ACIDNuCare Pharmaceuticals,Inc.7470a1ed-bc00-cb52-e053-2a91aa0a5c7d2024-07-15Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Weight Loss Support Plus Female BalanceFOENICULUM VULGARE, AMMONIUM BROMATUM, FUCUS VESICULOSUS, LECITHIN (DERIVED FROM EGG), CAPSICUM ANNUUM, CAULOPHYLLUM THALICTRINES, CIMICIFUGA RACEMOSA, GALIUM APARINE, HYPOTHALAMUS SUIS, KALI BICHROMICUM, LAC DEFLORATUM, PHYTOLACCA DECANDRA, RUBUS IDAEUS, THYROIDINUM (BOVINE), PITUITARUM POSTERIUM (BOVINE), ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, CALCAREA CARBONICA, ADRENALINUM, PHOSPHORUS, HEPAR SULPHURIS CALCAREUM, PROGESTERONE, OXYTOCINCarolinas Weight Loss Institute66249339-1e80-449f-9c2a-a030cdc71a0c2024-05-23WarningsExact identifier
unii: 1JQS135EYN
IntimateNATRUM CARBONICUM, SACCHARUM OFFICINALE, LITHIUM CARBONICUM, PLACENTA TOTALIS SUIS, LAC CANINUM, ANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, GERMANIUM METALLICUM, HELLEBORUS NIGER, MAGNESIA OXYDATA, RHUS GLABRA, STRAMONIUM, THUJA OCCIDENTALIS, DNA (HUMAN), OXYTOCIN, HYDROGEN, NEON, LAC MATERNA HUMANUMDeseret Biologicals, Inc.ca0447c1-606e-443a-b789-7d65143fec282024-05-13WarningsExact identifier
unii: 1JQS135EYN
Weight Loss Support Plus Female BalanceFOENICULUM VULGARE, AMMONIUM BROMATUM, FUCUS VESICULOSUS, LECITHIN (DERIVED FROM EGG), CAPSICUM ANNUUM, CAULOPHYLLUM THALICTROIDES, CIMICIFUGA RACEMOSA, GALIUM APARINE, HYPOTHALAMUS SUIS, KALI BICHROMICUM, LAC DEFLORATUM (NSPC), PHYTOLACCA DECANDRA, RUBUS IDAEUS, THYROIDINUM (BOVINE), PITUITARUM POSTERIUM ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, CALCAREA CARBONICA, ADRENALINUM, PHOSPHORUS, HEPAR SULPHURIS CALCAREUM, OXYTOCIN, PROGESTERONECarolinas Weight Loss Institute52ce70ad-7ed6-4559-8c4c-590bf7b10e652024-05-13WarningsExact identifier
unii: 1JQS135EYN
GI DistressACETICUM ACIDUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, COLIBACILLINUM CUM NATRUM MURIATICUM, COLOCYNTHIS, CROTON TIGLIUM, ECHINACEA (ANGUSTIFOLIA), FERRUM METALLICUM, GAMBOGIA, IRIS VERSICOLOR, LAC DEFLORATUM, MERCURIUS VIVUS, NATRUM PHOSPHORICUM, NUX VOMICA, PROTEUS (MIRABILIS), RICINUS COMMUNIS, VERATRUM ALBUMDeseret Biologicals, Inc.40df69fa-92ae-4f26-8664-36955cf395c52024-05-13WarningsExact identifier
unii: Q40Q9N063P
GI DistressECHINACEA (ANGUSTIFOLIA), NATRUM PHOSPHORICUM, COLCHICUM AUTUMNALE, ARSENICUM ALBUM, COLOCYNTHIS, CROTON TIGLIUM, GAMBOGIA, ACETICUM ACIDUM, ANTIMONIUM CRUDUM, BISMUTHUM SUBNITRICUM, CINCHONA OFFICINALIS, FERRUM METALLICUM, IRIS VERSICOLOR, LAC DEFLORATUM, MERCURIUS VIVUS, NUX VOMICA, RICINUS COMMUNIS, VERATRUM ALBUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (MIRABILIS)Deseret Biologicals, Inc.056ac695-82d3-4164-9123-79520b5deecc2024-05-08WarningsExact identifier
unii: Q40Q9N063P
Neurotransmitter ProAETHUSA CYNAPIUM, GINKGO BILOBA, KALI PHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALUMINA, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, CORTISONE ACETICUM, LEVOTHYROXINUM, LYCOPODIUM CLAVATUM, NADIDUM, PHOSPHORUS, UBIDECARENONUM, ZINCUM METALLICUM, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, GABA (GAMMA-AMINOBUTYRIC ACID), HISTAMINUM HYDROCHLORICUM, MELATONIN, NOREPINEPHRINE (BITARTRATE), OXYTOCIN, SEROTONIN (HYDROCHLORIDE)Energique, Inc.a80e5e2d-4c53-4b18-b89b-a7790073b7ed2024-05-06WarningsExact identifier
unii: 1JQS135EYN

Reported adverse events (FAERS/openFDA)#

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