oxytocin

Generic: oxytocin

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxytocin
Generic Name oxytocin
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

oxytocin 10 [USP'U]/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-021
Product ID 65219-021_9ac3d1b0-5944-4a20-87b1-423a712f429a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018248
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 65219021
Hyphenated Format 65219-021

Supplemental Identifiers

RxCUI
1791721
UPC
0365219021001
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 oxytocin (source: ndc)
Generic Name oxytocin (source: ndc)
Application Number NDA018248 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 [USP'U]/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-021-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-021-00)
source: ndc

Packages (1)

65219-021-01 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-021-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-021-00)

Ingredients (1)

oxytocin (10 [USP'U]/mL)

Linked Drug Pages (1)

Oxytocin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "9ac3d1b0-5944-4a20-87b1-423a712f429a", "openfda": {"nui": ["N0000009705", "N0000175828", "M0015703"], "upc": ["0365219021001"], "unii": ["1JQS135EYN"], "rxcui": ["1791721"], "spl_set_id": ["4c4c4b69-8bf7-472c-aafe-29805ba5c965"], "pharm_class_cs": ["Oxytocin [CS]"], "pharm_class_pe": ["Increased Uterine Smooth Muscle Contraction or Tone [PE]"], "pharm_class_epc": ["Oxytocic [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (65219-021-01)  / 1 mL in 1 VIAL, SINGLE-DOSE (65219-021-00)", "package_ndc": "65219-021-01", "marketing_start_date": "20240506"}], "brand_name": "Oxytocin", "product_id": "65219-021_9ac3d1b0-5944-4a20-87b1-423a712f429a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Increased Uterine Smooth Muscle Contraction or Tone [PE]", "Oxytocic [EPC]", "Oxytocin [CS]"], "product_ndc": "65219-021", "generic_name": "OXYTOCIN", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxytocin", "active_ingredients": [{"name": "OXYTOCIN", "strength": "10 [USP'U]/mL"}], "application_number": "NDA018248", "marketing_category": "NDA", "marketing_start_date": "20240506", "listing_expiration_date": "20261231"}