FDA.reportPublic FDA data

Oxytocin

Product NDC
63323-012
11-digit product format
633230012
Labeler code
63323
Product ID
63323-012_143745a3-4e90-49fc-9014-812276fe329f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYTOCIN
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA018248
Marketing category
NDA
Marketing start
2000-08-10
Substance
OXYTOCIN
Active strength
10 [USP'U]/mL
Pharmacologic classes
Increased Uterine Smooth Muscle Contraction or Tone [PE], Oxytocic [EPC], Oxytocin [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxytocin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYTOCIN10 [USP'U]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1JQS135EYN
Rxcui238013, 1791721

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3124a9ec-4142-06dc-5b1b-5c28cd8ea2fbProduct name220180829
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

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 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 MOIETY1JQS135EYNOXYTOCIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063POXYTOCIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
CHLOROBUTANOLINACTIVE INGREDIENTHM4YQM8WRCOXYTOCIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791721oxytocin 10 UNT in 1 ML InjectionPSN6d7d1280-f286-4f39-89f3-2b96571810e69
238013oxytocin 10 UNT/ML Injectable SolutionPSN6d7d1280-f286-4f39-89f3-2b96571810e69
17917211 ML oxytocin 10 UNT/ML InjectionSCD6d7d1280-f286-4f39-89f3-2b96571810e69
238013oxytocin 10 UNT/ML Injectable SolutionSCD6d7d1280-f286-4f39-89f3-2b96571810e69
1791721oxytocin 10 UNT per 1 ML InjectionSY6d7d1280-f286-4f39-89f3-2b96571810e69
1791721oxytocin 10 UNT in 1 ML InjectionPSNc7fd585a-99b7-4309-b003-a6cbef05372c7
238013oxytocin 10 UNT/ML Injectable SolutionPSNc7fd585a-99b7-4309-b003-a6cbef05372c7
17917211 ML oxytocin 10 UNT/ML InjectionSCDc7fd585a-99b7-4309-b003-a6cbef05372c7
238013oxytocin 10 UNT/ML Injectable SolutionSCDc7fd585a-99b7-4309-b003-a6cbef05372c7
1791721oxytocin 10 UNT per 1 ML InjectionSYc7fd585a-99b7-4309-b003-a6cbef05372c7
1791721oxytocin 10 UNT in 1 ML InjectionPSN18fe8365-86e3-414e-84dc-c98e097a2f364
17917211 ML oxytocin 10 UNT/ML InjectionSCD18fe8365-86e3-414e-84dc-c98e097a2f364
1791721oxytocin 10 UNT per 1 ML InjectionSY18fe8365-86e3-414e-84dc-c98e097a2f364
1791721oxytocin 10 UNT in 1 ML InjectionPSNb6f20a2c-3609-4b09-b8f7-8d8eaeb5c2422
17917211 ML oxytocin 10 UNT/ML InjectionSCDb6f20a2c-3609-4b09-b8f7-8d8eaeb5c2422
1791721oxytocin 10 UNT per 1 ML InjectionSYb6f20a2c-3609-4b09-b8f7-8d8eaeb5c2422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-012-016332300120125 VIAL in 1 TRAY (63323-012-01) > 1 mL in 1 VIAL (63323-012-00) 25 vial2000-08-100000-00-00NoNoCurrent
63323-012-026332300120230 mL in 1 VIAL, MULTI-DOSE30 mlHistorical
63323-012-03633230012031 mL in 1 VIAL1 mlHistorical
63323-012-066332300120610 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
63323-012-076332300120725 VIAL in 1 TRAY (63323-012-07) / 1 mL in 1 VIAL (63323-012-17) 25 vial2000-08-100000-00-00NoNoCurrent
63323-012-106332300121025 VIAL, MULTI-DOSE in 1 TRAY (63323-012-10) / 10 mL in 1 VIAL, MULTI-DOSE (63323-012-06) 2000-08-100000-00-00NoNoCurrent
63323-012-116332300121125 VIAL in 1 TRAY (63323-012-11) / 1 mL in 1 VIAL (63323-012-03) 25 vial2000-08-100000-00-00NoNoCurrent
63323-012-126332300121225 VIAL in 1 TRAY (63323-012-12) > 1 mL in 1 VIAL (63323-012-21) 25 vial2000-08-100000-00-00NoNoCurrent
63323-012-17633230012171 mL in 1 VIAL1 mlHistorical
63323-012-306332300123010 VIAL, MULTI-DOSE in 1 TRAY (63323-012-30) / 30 mL in 1 VIAL, MULTI-DOSE (63323-012-02) 2000-08-100000-00-00NoNoCurrent