Pitocin

Product NDC
42023-130
11-digit product format
420230130
Labeler code
42023
Product ID
42023-130_b493de99-bebb-46c3-946c-09c0e9c43832
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxytocin
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Par Health USA, LLC
Application
NDA018261
Marketing category
NDA
Marketing start
2018-05-01
Substance
OXYTOCIN
Active strength
10 [iU]/mL
Pharmacologic classes
Increased Uterine Smooth Muscle Contraction or Tone [PE], Oxytocic [EPC], Oxytocin [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pitocin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYTOCIN10 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1JQS135EYN
Rxcui207315, 238013

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
42023-130-06Pitocin50 mL in 1 VIALINJECTION5015
42023-130-06Pitocin6 in 1 CARTONINJECTION615

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-130-06ML - Milliliter42023-13056c61cbd-ef1f-452b-8211-8a6884e8195b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
oxytocinACTIVE INGREDIENT1JQS135EYNPITOCIN (OXYTOCIN) INJECTION [JHP PHARMACEUTICALS LLC]4
oxytocinACTIVE MOIETY1JQS135EYNPITOCIN (OXYTOCIN) INJECTION [JHP PHARMACEUTICALS LLC]4
acetic acidINACTIVE INGREDIENTQ40Q9N063PPITOCIN (OXYTOCIN) INJECTION [JHP PHARMACEUTICALS LLC]4
chlorobutanolINACTIVE INGREDIENTHM4YQM8WRCPITOCIN (OXYTOCIN) INJECTION [JHP PHARMACEUTICALS LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42023-130PITOCIN (OXYTOCIN) INJECTION [ENDO USA, INC.]12Current NDC, Legacy NDC, 2 package rows20240913_6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238013oxytocin 10 UNT/ML Injectable SolutionPSN6d4b2c25-2e5d-49b5-93bc-2ae8a20916d115
207315Pitocin 10 UNT/ML Injectable SolutionPSN6d4b2c25-2e5d-49b5-93bc-2ae8a20916d115
207315oxytocin 10 UNT/ML Injectable Solution [Pitocin]SBD6d4b2c25-2e5d-49b5-93bc-2ae8a20916d115
238013oxytocin 10 UNT/ML Injectable SolutionSCD6d4b2c25-2e5d-49b5-93bc-2ae8a20916d115
207315Pitocin 10 UNT/ML Injectable SolutionSY6d4b2c25-2e5d-49b5-93bc-2ae8a20916d115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42023-130-06420230130066 VIAL in 1 CARTON (42023-130-06) / 50 mL in 1 VIAL6 vial2018-05-010000-00-00NoNoCurrent