pitocin

Generic: oxytocin

Labeler: par health usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name pitocin
Generic Name oxytocin
Labeler par health usa, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

oxytocin 10 [iU]/mL

Manufacturer
Par Health USA, LLC

Identifiers & Regulatory

Product NDC 42023-116
Product ID 42023-116_8a72fd6b-28ec-44fa-be97-e6f5de8119cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018261
Listing Expiration 2026-12-31
Marketing Start 2024-05-06

Pharmacologic Class

Established (EPC)
oxytocic [epc]
Chemical Structure
oxytocin [cs]
Physiologic Effect
increased uterine smooth muscle contraction or tone [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42023116
Hyphenated Format 42023-116

Supplemental Identifiers

RxCUI
207315 238013 1791721 1791723
UNII
1JQS135EYN
NUI
N0000009705 N0000175828 M0015703

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pitocin (source: ndc)
Generic Name oxytocin (source: ndc)
Application Number NDA018261 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 [iU]/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (42023-116-93) / 10 mL in 1 VIAL
source: ndc

Packages (1)

42023-116-93 25 VIAL in 1 CARTON (42023-116-93) / 10 mL in 1 VIAL

Ingredients (1)

oxytocin (10 [iU]/mL)

Linked Drug Pages (3)

Pitocin ndc-match (0.9) Pitocin ndc-match (0.9) Pitocin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "8a72fd6b-28ec-44fa-be97-e6f5de8119cf", "openfda": {"nui": ["N0000009705", "N0000175828", "M0015703"], "unii": ["1JQS135EYN"], "rxcui": ["207315", "238013", "1791721", "1791723"], "spl_set_id": ["6e5a66fc-e507-497c-b5ce-44a8c95898ad"], "pharm_class_cs": ["Oxytocin [CS]"], "pharm_class_pe": ["Increased Uterine Smooth Muscle Contraction or Tone [PE]"], "pharm_class_epc": ["Oxytocic [EPC]"], "manufacturer_name": ["Par Health USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (42023-116-93)  / 10 mL in 1 VIAL", "package_ndc": "42023-116-93", "marketing_start_date": "20240506"}], "brand_name": "Pitocin", "product_id": "42023-116_8a72fd6b-28ec-44fa-be97-e6f5de8119cf", "dosage_form": "INJECTION", "pharm_class": ["Increased Uterine Smooth Muscle Contraction or Tone [PE]", "Oxytocic [EPC]", "Oxytocin [CS]"], "product_ndc": "42023-116", "generic_name": "oxytocin", "labeler_name": "Par Health USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pitocin", "active_ingredients": [{"name": "OXYTOCIN", "strength": "10 [iU]/mL"}], "application_number": "NDA018261", "marketing_category": "NDA", "marketing_start_date": "20240506", "listing_expiration_date": "20261231"}