FDA.reportPublic FDA data

Pitocin

Product NDC
42023-116
11-digit product format
420230116
Labeler code
42023
Product ID
42023-116_c269323e-4670-4bb5-b67b-f3e0e7a225c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxytocin
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Par Health USA, LLC
Application
NDA018261
Marketing category
NDA
Marketing start
2024-05-06
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, 1791721, 1791723

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
42023-116-01Pitocin10 mL in 1 VIALINJECTION1016
42023-116-01Pitocin1 in 1 CARTONINJECTION116
42023-116-02Pitocin25 in 1 CARTONINJECTION2516
42023-116-02Pitocin10 mL in 1 VIALINJECTION1016
42023-116-25Pitocin1 mL in 1 VIALINJECTION116
42023-116-25Pitocin25 in 1 TRAYINJECTION2516
42023-116-93Pitocin10 mL in 1 VIALINJECTION1015
42023-116-93Pitocin25 in 1 CARTONINJECTION2515
42023-116-73Pitocin25 in 1 CARTONINJECTION2510
42023-116-73Pitocin10 mL in 1 VIALINJECTION1010
42023-116-83Pitocin25 in 1 CARTONINJECTION2510
42023-116-83Pitocin1 mL in 1 VIALINJECTION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-116-01ML - Milliliter42023-116410c7534-e462-44d9-8905-79ea5731cbcb12012-07-24
42023-116-02ML - Milliliter42023-1163cef2e57-13fa-4492-b875-255bdfc8b43c12012-07-24
42023-116-25ML - Milliliter42023-116d9a9284b-977e-4d59-9d55-56800570cf6812012-07-24
42023-116-73ML - Milliliter42023-116260aafe1-5f7a-4444-8686-0064b0e83d5012024-02-14
42023-116-83ML - Milliliter42023-1167ca7d97f-dbb6-4b5d-94cc-f0d69536065312024-01-04
42023-116-93ML - Milliliter42023-1161b6411dd-863d-4be4-a039-a682dad1574512024-07-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
oxytocinACTIVE INGREDIENT1JQS135EYNPITOCIN (OXYTOCIN) INJECTION [PAR PHARMACEUTICAL, INC.]6
oxytocinACTIVE MOIETY1JQS135EYNPITOCIN (OXYTOCIN) INJECTION [PAR PHARMACEUTICAL, INC.]6
acetic acidINACTIVE INGREDIENTQ40Q9N063PPITOCIN (OXYTOCIN) INJECTION [PAR PHARMACEUTICAL, INC.]6
chlorobutanolINACTIVE INGREDIENTHM4YQM8WRCPITOCIN (OXYTOCIN) INJECTION [PAR PHARMACEUTICAL, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42023-116PITOCIN (OXYTOCIN) INJECTION [ENDO USA, INC.]14Current NDC, Legacy NDC, 6 package rows20240913_969d5b35-0add-4c23-9605-6a5b6ab65c95.zip
42023-116PITOCIN (OXYTOCIN) INJECTION [ENDO USA, INC.]13Current NDC, Legacy NDC, 2 package rows20240913_6e5a66fc-e507-497c-b5ce-44a8c95898ad.zip
42023-116PITOCIN (OXYTOCIN) INJECTION [ENDO USA, INC.]9Current NDC, Legacy NDC, 4 package rows20240913_dddcdcc3-cd4d-4573-98ac-9468bea23a8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791721oxytocin 10 UNT in 1 ML InjectionPSN969d5b35-0add-4c23-9605-6a5b6ab65c9516
238013oxytocin 10 UNT/ML Injectable SolutionPSN969d5b35-0add-4c23-9605-6a5b6ab65c9516
1791723Pitocin 10 UNT in 1 ML InjectionPSN969d5b35-0add-4c23-9605-6a5b6ab65c9516
207315Pitocin 10 UNT/ML Injectable SolutionPSN969d5b35-0add-4c23-9605-6a5b6ab65c9516
17917231 ML oxytocin 10 UNT/ML Injection [Pitocin]SBD969d5b35-0add-4c23-9605-6a5b6ab65c9516
207315oxytocin 10 UNT/ML Injectable Solution [Pitocin]SBD969d5b35-0add-4c23-9605-6a5b6ab65c9516
17917211 ML oxytocin 10 UNT/ML InjectionSCD969d5b35-0add-4c23-9605-6a5b6ab65c9516
238013oxytocin 10 UNT/ML Injectable SolutionSCD969d5b35-0add-4c23-9605-6a5b6ab65c9516
1791721oxytocin 10 UNT per 1 ML InjectionSY969d5b35-0add-4c23-9605-6a5b6ab65c9516
1791723Pitocin 10 UNT per 1 ML InjectionSY969d5b35-0add-4c23-9605-6a5b6ab65c9516
207315Pitocin 10 UNT/ML Injectable SolutionSY969d5b35-0add-4c23-9605-6a5b6ab65c9516
1791721oxytocin 10 UNT in 1 ML InjectionPSN6e5a66fc-e507-497c-b5ce-44a8c95898ad15
238013oxytocin 10 UNT/ML Injectable SolutionPSN6e5a66fc-e507-497c-b5ce-44a8c95898ad15
1791723Pitocin 10 UNT in 1 ML InjectionPSN6e5a66fc-e507-497c-b5ce-44a8c95898ad15
207315Pitocin 10 UNT/ML Injectable SolutionPSN6e5a66fc-e507-497c-b5ce-44a8c95898ad15
17917231 ML oxytocin 10 UNT/ML Injection [Pitocin]SBD6e5a66fc-e507-497c-b5ce-44a8c95898ad15
207315oxytocin 10 UNT/ML Injectable Solution [Pitocin]SBD6e5a66fc-e507-497c-b5ce-44a8c95898ad15
17917211 ML oxytocin 10 UNT/ML InjectionSCD6e5a66fc-e507-497c-b5ce-44a8c95898ad15
238013oxytocin 10 UNT/ML Injectable SolutionSCD6e5a66fc-e507-497c-b5ce-44a8c95898ad15
1791721oxytocin 10 UNT per 1 ML InjectionSY6e5a66fc-e507-497c-b5ce-44a8c95898ad15
1791723Pitocin 10 UNT per 1 ML InjectionSY6e5a66fc-e507-497c-b5ce-44a8c95898ad15
207315Pitocin 10 UNT/ML Injectable SolutionSY6e5a66fc-e507-497c-b5ce-44a8c95898ad15
1791721oxytocin 10 UNT in 1 ML InjectionPSNdddcdcc3-cd4d-4573-98ac-9468bea23a8b10
238013oxytocin 10 UNT/ML Injectable SolutionPSNdddcdcc3-cd4d-4573-98ac-9468bea23a8b10
1791723Pitocin 10 UNT in 1 ML InjectionPSNdddcdcc3-cd4d-4573-98ac-9468bea23a8b10
207315Pitocin 10 UNT/ML Injectable SolutionPSNdddcdcc3-cd4d-4573-98ac-9468bea23a8b10
17917231 ML oxytocin 10 UNT/ML Injection [Pitocin]SBDdddcdcc3-cd4d-4573-98ac-9468bea23a8b10
207315oxytocin 10 UNT/ML Injectable Solution [Pitocin]SBDdddcdcc3-cd4d-4573-98ac-9468bea23a8b10
17917211 ML oxytocin 10 UNT/ML InjectionSCDdddcdcc3-cd4d-4573-98ac-9468bea23a8b10
238013oxytocin 10 UNT/ML Injectable SolutionSCDdddcdcc3-cd4d-4573-98ac-9468bea23a8b10
1791721oxytocin 10 UNT per 1 ML InjectionSYdddcdcc3-cd4d-4573-98ac-9468bea23a8b10
1791723Pitocin 10 UNT per 1 ML InjectionSYdddcdcc3-cd4d-4573-98ac-9468bea23a8b10
207315Pitocin 10 UNT/ML Injectable SolutionSYdddcdcc3-cd4d-4573-98ac-9468bea23a8b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42023-116-01420230116011 VIAL in 1 CARTON (42023-116-01) > 10 mL in 1 VIAL1 vial2008-02-012021-08-31NoNoCurrent
42023-116-024202301160225 VIAL in 1 CARTON (42023-116-02) / 10 mL in 1 VIAL25 vial2008-02-010000-00-00NoNoCurrent
42023-116-254202301162525 VIAL in 1 TRAY (42023-116-25) / 1 mL in 1 VIAL25 vial2008-02-010000-00-00NoNoCurrent
42023-116-734202301167325 VIAL in 1 CARTON (42023-116-73) / 10 mL in 1 VIAL25 vial2023-12-22NoNoHistorical
42023-116-834202301168325 VIAL in 1 CARTON (42023-116-83) / 1 mL in 1 VIAL25 vial2023-12-22NoNoHistorical
42023-116-934202301169325 VIAL in 1 CARTON (42023-116-93) / 10 mL in 1 VIAL25 vial2024-05-06NoNoHistorical