Oxytocin

Product NDC
55154-9584
11-digit product format
551549584
Labeler code
55154
Product ID
55154-9584_e511e878-05c0-416a-968f-d61fdbd59e68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYTOCIN
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Cardinal Health 107, 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
Rxcui1791721

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
55154-9584-5Oxytocin1 mL in 1 VIALINJECTION, SOLUTION14
55154-9584-5Oxytocin5 in 1 BAGINJECTION, SOLUTION54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-9584OXYTOCIN INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC]3Current NDC, Legacy NDC, 2 package rows20241013_18fe8365-86e3-414e-84dc-c98e097a2f36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-9584-5551549584055 VIAL in 1 BAG (55154-9584-5) / 1 mL in 1 VIAL5 vial2019-11-080000-00-00NoNoCurrent