FDA.reportPublic FDA data

NDC 63323-012-17 - 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
63323-012
Requested NDC
63323-012-17
Package NDCs from labels
63323-012-06, 63323-012-10, 63323-012-02, 63323-012-30, 63323-012-03, 63323-012-11, 63323-012-17, 63323-012-07
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Oxytocin Injection, USPREMEDYREPACK INC.2026-09-01HUMAN PRESCRIPTION DRUG LABEL
Oxytocin - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2026-01-12HUMAN PRESCRIPTION DRUG LABEL
Oxytocin - Cardinal Health 107, LLCCardinal Health 107, LLC2025-06-20HUMAN PRESCRIPTION DRUG LABEL
Oxytocin - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2024-10-15HUMAN PRESCRIPTION DRUG LABEL
Model AA-8565CV-ACT Model AA-8565CV - Aerospace Accessory Service, IncAerospace Accessory Service, Inc2021-05-18MEDICAL DEVICE
Oxytocin - Cardinal HealthCardinal Health2020-06-04HUMAN PRESCRIPTION DRUG LABEL
Oxytocin - Cardinal HealthCardinal Health2019-09-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-012-07Oxytocin25 in 1 TRAYINJECTION, SOLUTION259
63323-012-17Oxytocin1 mL in 1 VIALINJECTION, SOLUTION19
63323-012-02Oxytocin30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION307
63323-012-03Oxytocin1 mL in 1 VIALINJECTION, SOLUTION17
63323-012-06Oxytocin10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION107
63323-012-10Oxytocin25 in 1 TRAYINJECTION, SOLUTION257
63323-012-11Oxytocin25 in 1 TRAYINJECTION, SOLUTION257
63323-012-30Oxytocin10 in 1 TRAYINJECTION, SOLUTION107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-012OXYTOCIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9Current NDC, Legacy NDC, 2 package rows20241127_6d7d1280-f286-4f39-89f3-2b96571810e6.zip
63323-012OXYTOCIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 6 package rows20231026_c7fd585a-99b7-4309-b003-a6cbef05372c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-012-01ML - Milliliter63323-012052a8ba6-aa27-434e-8251-41c918d1650712013-02-13
63323-012-02ML - Milliliter63323-0126b888f76-9da2-48e1-a975-b225062226fa12021-05-05
63323-012-03ML - Milliliter63323-0123a2c557d-20bf-4a78-881b-1588d61b628812020-01-03
63323-012-06ML - Milliliter63323-0127862b5a3-ef73-44b3-a89e-493ccc6e5c2312019-09-05
63323-012-07ML - Milliliter63323-012f5a5734c-514a-4f23-9a52-9383dc446e7912020-02-13
63323-012-10ML - Milliliter63323-01283be660b-7e9f-4b18-84a9-b898e408f75212013-02-13
63323-012-11ML - Milliliter63323-012eafdb176-6892-4ff5-9ed0-0362316426ab12020-01-03
63323-012-12ML - Milliliter63323-01262b78a3c-8843-45ab-992d-09cf4756c58812013-02-13
63323-012-17ML - Milliliter63323-0122a7d0a2c-f726-4202-999b-2e123de8432a12020-02-13
63323-012-30ML - Milliliter63323-012f3bdbfc9-4587-43c5-a86e-e12fc1102b7612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYTOCINACTIVE INGREDIENT1JQS135EYNOXYTOCIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
OXYTOCINACTIVE MOIETY1JQS135EYNOXYTOCIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063POXYTOCIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
CHLOROBUTANOLINACTIVE INGREDIENTHM4YQM8WRCOXYTOCIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
OXYTOCINACTIVE INGREDIENT1JQS135EYNOXYTOCIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
OXYTOCINACTIVE INGREDIENT1JQS135EYNOXYTOCIN INJECTION, SOLUTION [CARDINAL HEALTH]1
OXYTOCINACTIVE MOIETY1JQS135EYNOXYTOCIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
OXYTOCINACTIVE MOIETY1JQS135EYNOXYTOCIN INJECTION, SOLUTION [CARDINAL HEALTH]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063POXYTOCIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063POXYTOCIN INJECTION, SOLUTION [CARDINAL HEALTH]1
CHLOROBUTANOLINACTIVE INGREDIENTHM4YQM8WRCOXYTOCIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
CHLOROBUTANOLINACTIVE INGREDIENTHM4YQM8WRCOXYTOCIN INJECTION, SOLUTION [CARDINAL HEALTH]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 759 · 15,176 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEFORTUNE PHARMACAL COMPANY LIMITED33e1bec0-323b-40b7-809a-cb65a71ad0ce2026-09-17WarningsExact identifier
unii: 362O9ITL9D
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 451W47IQ8X
METOPROLOL TARTRATEMETOPROLOL TARTRATEREMEDYREPACK INC.0ca72c89-82c5-4b31-b515-1a8b8e82ec592026-09-10Warnings, Adverse reactionsExact identifier
rxcui: 866511
unii: W5S57Y3A5L
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEKroger Companyfd41e4a4-330f-4409-8ba3-0b3bb6f45bca2026-09-10WarningsExact identifier
unii: 362O9ITL9D
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDERaritan Pharmaceuticals Inc303d7651-9c8f-4a14-9f2c-7181fa0f003e2026-09-09WarningsExact identifier
unii: TC2D6JAD40
childrens fever reducer and pain relieverACETAMINOPHENRite Aid Corporation7f445de3-30cf-4bd8-892d-05979cd399e72026-09-09WarningsExact identifier
unii: 362O9ITL9D
dual actionACETAMINOPHEN, IBUPROFENRite Aid Corporation54b08d24-d5e9-4111-9d97-329896e8309d2026-09-09WarningsExact identifier
unii: 362O9ITL9D
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc2cb3e17f-3858-4773-a53f-0860ae6ff1b92026-09-09WarningsExact identifier
unii: 362O9ITL9D
calcium chlorideCALCIUM CHLORIDEEskayef Pharmaceuticals Limited5b0bd762-4c87-597e-e063-6394a90a83032026-09-09Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Advanced Alcohol Gel SanitizerALCOHOLBetco Corporation, Ltda23b997c-b010-5985-e053-2995a90aadf32026-09-09WarningsExact identifier
unii: 3K9958V90M
North Woods Derma Foam Hand SanitizerBENZALKONIUM CHLORIDESuperior Chemical Corporationad51a175-2b91-fd14-e053-2995a90ad54d2026-09-09WarningsExact identifier
unii: F5UM2KM3W7
Touchland Power Mist Hydrating Hand Sanitizer Cotton CandyALCOHOLChurch & Dwight Co., Inc.5b107dd2-a76c-9c80-e063-6394a90aaedb2026-09-09WarningsExact identifier
unii: 3K9958V90M
Pink Touchland Power Mist Hydrating Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc.5b108f13-6474-fdbd-e063-6294a90a1a2b2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mango PassionALCOHOLChurch & Dwight Co., Inc.5b1099ae-f1e8-b79d-e063-6394a90add6f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Gentle Mist Hand Sanitizer Lily of The ValleyALCOHOLChurch & Dwight Co., Inc.5b10a3a7-1cca-2a34-e063-6294a90a3f6c2026-09-09WarningsExact identifier
unii: 3K9958V90M
Alcohol Free Foaming Hand SanitizerBENZALKONIUM CHLORIDEBetco Corporation, Ltd.7e038b0a-4813-4f4b-ad66-0584d75a064f2026-09-09WarningsExact identifier
unii: F5UM2KM3W7
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9a9fc7c-31da-ea3f-e053-2a95a90a0eab2026-09-09WarningsExact identifier
application number: M003
unii: F5UM2KM3W7
Ultra Blue Antibacterial Foaming Skin CleanserBENZALKONIUM CHLORIDEBetco Corporation, Ltdaa8f5b05-882d-d05a-e053-2995a90abaea2026-09-09WarningsExact identifier
unii: F5UM2KM3W7
Touchland Glow Mist Hand Sanitizer RosewaterALCOHOLChurch & Dwight Co., Inc.5a850866-bc5d-e595-e063-6394a90a335f2026-09-09WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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