FDA.reportPublic FDA data

NDC 63323-012-06 - 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
63323-012-06
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 2 of 741 · 14,817 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDIRECT RXbae9c9c1-107f-0fcb-e053-2a95a90a75b22026-09-09Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
nitroglycerinNITROGLYCERINMedical Purchasing Solutions, LLC.5b150cd2-fac8-86ce-e063-6294a90a67b92026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 198039
unii: G59M7S0WS3
Low Dose AspirinASPIRINStrategic Sourcing Services LLC7ce4807e-7bd5-41f1-a9c7-1f3af6acdc092026-09-09WarningsExact identifier
unii: R16CO5Y76E
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
unii: 451W47IQ8X
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
unii: 362O9ITL9D
DextroseDEXTROSE MONOHYDRATEHenry Schein, Inc.8cf6943f-16e8-4521-863c-09bb0b55e2a92026-09-09Warnings, Adverse reactionsExact identifier
application number: NDA019445
rxcui: 727517
unii: LX22YL083G
DRx Choice maximum strength Severe Cough plus sore throatACETAMINOPHEN, DEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALSa096cb76-0d1c-4ca8-854a-5199da0bc8f72026-09-09WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Extra StrengthACETAMINOPHENWal-Mart Stores Inc78874258-16cc-40b5-9e15-5943eddfce942026-09-08WarningsExact identifier
unii: 362O9ITL9D
SORE THROATPHENOLRaritan Pharmaceuticals Inc43ce374a-824c-4034-bf04-c351b4d8015b2026-09-08WarningsExact identifier
unii: 339NCG44TV
Alcohol Prep Pad MediumALCOHOL PREP PADYangzhou Huanrui Medical Technology Co., Ltd5af3eedc-d01e-c9e9-e063-6394a90a49e12026-09-08WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
RectivNITROGLYCERINAllergan, Inc.603aa9ed-54c4-4a35-ade4-690fa44850e42026-09-08Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5af9f31b-0c92-e3a9-e063-6394a90a38c92026-09-08WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
unii: 362O9ITL9D
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyefb5f0b9-9825-ab23-e053-2995a90a26ab2026-09-08WarningsExact identifier
unii: 362O9ITL9D
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5afc0201-490e-ccf3-e063-6394a90aadad2026-09-08WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl FREE OFDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company01906eed-78ee-f2a1-e063-6294a90a809b2026-09-08WarningsExact identifier
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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