Oxytocin

Product NDC
0641-6115
11-digit product format
006416115
Labeler code
0641
Product ID
0641-6115_43bde17d-d249-4ad7-9136-a4ecd9dc648d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxytocin
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA018243
Marketing category
NDA
Marketing start
1980-04-29
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0641-6115-252025-01-30C16284748780-12cef2736-7f27-d83d-e063-dadaa90ab31fOxytocin Injection, USP (synthetic)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6115-01Oxytocin10 mL in 1 VIALINJECTION103
0641-6115-25Oxytocin25 in 1 CARTONINJECTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6115-01ML - Milliliter0641-61155f654325-5d51-43d3-b685-4d6acf0d0ba612012-07-24
0641-6115-25ML - Milliliter0641-61151b040dc4-4b03-4b77-8542-19857f1c0ec112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYTOCINACTIVE INGREDIENT1JQS135EYNOXYTOCIN INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
OXYTOCINACTIVE MOIETY1JQS135EYNOXYTOCIN INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063POXYTOCIN INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
CHLOROBUTANOLINACTIVE INGREDIENTHM4YQM8WRCOXYTOCIN INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
WATERINACTIVE INGREDIENT059QF0KO0ROXYTOCIN INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6115OXYTOCIN INJECTION [HIKMA PHARMACEUTICALS USA INC.]3Legacy NDC, 2 package rows20191231_a9b62187-4141-487c-a9da-f42ad7f9b408.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791721oxytocin 10 UNT in 1 ML InjectionPSNa9b62187-4141-487c-a9da-f42ad7f9b4083
238013oxytocin 10 UNT/ML Injectable SolutionPSNa9b62187-4141-487c-a9da-f42ad7f9b4083
17917211 ML oxytocin 10 UNT/ML InjectionSCDa9b62187-4141-487c-a9da-f42ad7f9b4083
238013oxytocin 10 UNT/ML Injectable SolutionSCDa9b62187-4141-487c-a9da-f42ad7f9b4083
1791721oxytocin 10 UNT per 1 ML InjectionSYa9b62187-4141-487c-a9da-f42ad7f9b4083

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6115-010064161150110 mL in 1 VIAL10 mlHistorical
0641-6115-250064161152525 VIAL in 1 CARTON (0641-6115-25) > 10 mL in 1 VIAL (0641-6115-01) 25 vial1980-04-290000-00-00NoNoCurrent