Oxytocin

Product NDC
70518-4233
11-digit product format
705184233
Labeler code
70518
Product ID
70518-4233_40064d1d-04fe-9259-e063-6394a90ab031
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYTOCIN
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
NDA018248
Marketing category
NDA
Marketing start
2024-11-18
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
70518-4233-0Oxytocin25 in 1 TRAYINJECTION, SOLUTION252
70518-4233-1Oxytocin1 mL in 1 VIALINJECTION, SOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4233OXYTOCIN INJECTION, SOLUTION [REMEDYREPACK INC.]1Current NDC, 2 package rows20241121_b6f20a2c-3609-4b09-b8f7-8d8eaeb5c242.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
70518-4233-07051842330025 VIAL in 1 TRAY (70518-4233-0) / 1 mL in 1 VIAL (70518-4233-1) 25 vial2024-11-18NoNoCurrent
70518-4233-1705184233011 mL in 1 VIAL1 mlHistorical