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Oxytocin 10 [USP'U]/mL Injection, Solution — NDC 63323-0012-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Oxytocin 10 [USP'U]/mL Injection, Solution — NDC 63323-012-10 (Billing 63323-0012-10)

by Fresenius Kabi USA, LLC · 25 VIAL, MULTI-DOSE in 1 TRAY / 10 mL in 1 VIAL, MULTI-DOSE

This is a package of Oxytocin 10 [USP'U]/mL Injection, Solution from Fresenius Kabi USA, LLC, marketed since Aug 2000 and currently FDA-listed.

NDC 63323-0012-10
🏷️ FDA NDC (as labeled) 63323-012-10 billing pads the product segment with a zero
This package
Contains10 mL in 1 vial, multi-dose Pack sizes6 compare ↓
Product page 63323-0012-11 Also comes in: 10 vials 63323-012-30 25 vials 63323-012-07 25 vials 63323-012-12 25 vials 63323-012-01 25 vials 63323-012-11
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 63323-012-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63323 labeler · 012 product · 10 package
Package marketed since
Aug 10, 2000
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0363323012175
Medicaid fills, this package
177 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63323-012-10
Product NDC 63323-012
11-digit billing NDC 63323001210
NCPDP billing unit ML — per mL (volume)
RxCUI 238013, 1791721
UNII 1JQS135EYN
UPC 0363323012175
Application # NDA018248
SPL Set ID 6d7d1280-f286-4f39-89f3-2b96571810e6
Established class (EPC) Oxytocic
Physiologic effect Increased Uterine Smooth Muscle Contraction or Tone
Chemical class Oxytocin
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2000-08-10
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance OXYTOCIN
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 29000030002005
GPI class Oxytocin
GCN Seq No 003283
GCN 11400
HICL code 001447
Ingredient (HICL) Oxytocin
HIC1 code G
Therapeutic class — broad (HIC1) Female Genital System
HIC2 code G3
Therapeutic class — intermediate (HIC2) Oxytocics
HIC3 code G3A
Therapeutic class — specific (HIC3) Oxytocics
AHFS code 76:00.00.00
AHFS class Oxytocics
FDB label name OXYTOCIN 100 UNIT/10 ML VIAL
FDB brand name Oxytocin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 003283
  • GCN: 11400
  • GPI-14 (Medi-Span): 29000030002005
  • HICL (First Databank): 001447
  • AHFS class code: 76:00.00.00
  • RxCUI (RxNorm): 238013
Why two NDCs? The FDA registers this code as 63323-012-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63323-0012-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Oxytocic class.

Pharmacologic class Oxytocic
Drug family (ATC) Oxytocin and analogues
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name OXYTOCIN 100 UNIT/10 ML VIAL Ingredient Oxytocin
📖 What it is MedlinePlus · NLM

Oxytocin injection is used to begin or improve contractions during labor. Oxytocin also is used to reduce bleeding after childbirth. It also may be used along with other medications or procedures to end a pregnancy. Oxytocin is in a class of medications called oxytocic hormones. It works by stimulating uterine contractions.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It makes the uterus contract. It's used to start or strengthen labor when there's a medical reason, to help manage incomplete or inevitable abortion, and to control bleeding after...
  • A healthcare professional gives it in a hospital. To start or strengthen labor, it goes through an IV drip with a pump and close monitoring. After delivery, it may be given by IV o...
  • Nausea and vomiting are possible. Heart rhythm changes and spikes in blood pressure have also been reported. Your team watches your contractions and your baby's heart rate closely.
  • Yes. Overly strong contractions can lead to uterine rupture, bleeding, and harm to the baby. Water intoxication and severe allergic reactions can also happen. If contractions get t...
📖 Read our full Oxytocin Injection guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J2590 No ASP payment limit on file for J2590 this quarter.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 vials 25 vials 25 vials 25 vials 25 vials
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)63323-012-10
11-digit billing NDC63323-0012-10
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ2590
DescriptorINJECTION, OXYTOCIN, UP TO 10 UNITS
Billing units / pkg1 units
How the units are derivedThis package is 10 ML; the HCPCS unit is 10 U, so one package = 1 billing unit.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63323-0012-07 63323-012-07 25 VIAL in 1 TRAY / 1 mL in 1 VIAL 2019-11-08 — Active
63323-0012-12 63323-012-12 25 VIAL in 1 TRAY / 1 mL in 1 VIAL 2000-08-10 — Active
63323-0012-01 63323-012-01 25 VIAL in 1 TRAY / 1 mL in 1 VIAL 2000-08-10 — Active
63323-0012-10 You're viewing this 25 VIAL, MULTI-DOSE in 1 TRAY / 10 mL in 1 VIAL, MULTI-DOSE 2000-08-10 — Active
63323-0012-11 63323-012-11 Main listing 25 VIAL in 1 TRAY / 1 mL in 1 VIAL 2000-08-10 — Active
63323-0012-30 63323-012-30 10 VIAL, MULTI-DOSE in 1 TRAY / 30 mL in 1 VIAL, MULTI-DOSE 2000-08-10 — Active

This pack accounts for about 19% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 25 vial, multi-dose in 1 tray / 10 ml in 1 vial, multi-dose.
What NDC number is used to bill for this package of Oxytocin 10 [USP'U]/mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Oxytocin 10 [USP'U]/mL 00143-9742-25 West-Ward 25 vials — AP FDA listed —
Oxytocin 10 [USP'U]/mL 00143-9743-25 West-Ward 25 vials — AP FDA listed —
Oxytocin 10 [USP'U]/mLthis 63323-0012-10 Fresenius 25 vials — AP FDA listed —
Oxytocin 10 [USP'U]/mL 55154-9584-05 Cardinal 5 vials — AP FDA listed —
Oxytocin 10 [USP'U]/mL 70518-4233-00 REMEDYREPACK 25 vials — AP FDA listed —
Oxytocin 10 [USP'U]/mL 65219-0021-01 Fresenius 25 vials — AP FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2000
On the market since
Aug 2000
📍
2026
Currently FDA-listed
26 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Oxytocin Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII Q40Q9N063P
    Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
  • UNII HM4YQM8WRC
    Chlorobutanol is a colorless crystalline chemical used as a preservative in medicines. It prevents bacterial and fungal growth to maintain product safety and shelf life.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationNDA018248 (NDA)
Labeler code63323
First marketedAug 2000
Product typeHuman Prescription Drug
Portfolio554 products on file

More NDCs from Fresenius Kabi USA, LLC labeler code 63323

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

INDICATIONS AND USAGE IMPORTANT NOTICE: Oxytocin Injection, USP (synthetic) is indicated for the medical rather than the elective induction of labor. Available data and information are inadequate to define the benefits to risks considerations in the use of the drug product for elective induction. Elective induction of labor is defined as the initiation of labor for convenience in an individual with a term pregnancy who is free of medical indications.

Antepartum Oxytocin injection (synthetic) is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable, in order to achieve early vaginal delivery for fetal or maternal reasons. It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, pre-eclampsia at or near term, when delivery is in the best interest of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) adjunctive therapy in the management of incomplete or inevitable abortion.

In the first trimester, curettage is generally considered primary therapy. In second trimester abortion, oxytocin infusion will often be successful in emptying the uterus. Other means of therapy, however, may be required in such cases.

Postpartum Oxytocin injection (synthetic) is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.

Antepartum Oxytocin injection (synthetic) is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable, in order to achieve early vaginal delivery for fetal or maternal reasons. It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, pre-eclampsia at or near term, when delivery is in the best interest of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) adjunctive therapy in the management of incomplete or inevitable abortion.

In the first trimester, curettage is generally considered primary therapy. In second trimester abortion, oxytocin infusion will often be successful in emptying the uterus. Other means of therapy, however, may be required in such cases.

Postpartum Oxytocin injection (synthetic) is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Dosage of oxytocin is determined by uterine response. The following dosage information is based upon the various regimens and indications in general use. Induction or Stimulation of Labor Intravenous infusion (drip method) is the only acceptable method of administration for the induction or stimulation of labor.

Accurate control of the rate of infusion flow is essential. An infusion pump or other such device and frequent monitoring of strength of contractions and fetal heart rate are necessary for the safe administration of oxytocin for the induction or stimulation of labor. If uterine contractions become too powerful, the infusion can be abruptly stopped, and oxytocic stimulation of the uterine musculature will soon wane.

An intravenous infusion of a non-oxytocin containing solution should be started. Physiologic electrolyte solutions should be used except under unusual circumstances. To prepare the usual solution for intravenous infusion–one mL (10 units) is combined aseptically with 1,000 mL of a non-hydrating diluent.

The combined solution, rotated in the infusion bottle to insure thorough mixing, contains 10 mU/mL. Add the container with dilute oxytocic solution to the system through the use of a constant infusion pump or other such device to control accurately the rate of infusion. The initial dose should be no more than 1 to 2 mU/min.

The dose may be gradually increased in increments of no more than 1 to 2 mU/min., until a contraction pattern has been established which is similar to normal labor. The fetal heart rate, resting uterine tone, and the frequency, duration, and force of contractions should be monitored. The oxytocin infusion should be discontinued immediately in the event of uterine hyperactivity or fetal distress.

Oxygen should be administered to the mother. The mother and fetus must be evaluated by the responsible physician. Control of Postpartum Uterine Bleeding Intravenous Infusion ( Drip Method )—To control postpartum bleeding, 10 to 40 units of oxytocin may be added to 1,000 mL of a nonhydrating diluent and run at a rate necessary to control uterine atony.

Intramuscular Administration —1 mL (10 units) of oxytocin can be given after delivery of the placenta. Treatment of Incomplete or Inevitable Abortion Intravenous infusion with physiologic saline solution, 500 mL, or 5% dextrose in physiologic saline solution to which 10 units of oxytocin have been added should be infused at a rate of 20 to 40 drops/minute. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Induction or Stimulation of Labor Intravenous infusion (drip method) is the only acceptable method of administration for the induction or stimulation of labor. Accurate control of the rate of infusion flow is essential. An infusion pump or other such device and frequent monitoring of strength of contractions and fetal heart rate are necessary for the safe administration of oxytocin for the induction or stimulation of labor.

If uterine contractions become too powerful, the infusion can be abruptly stopped, and oxytocic stimulation of the uterine musculature will soon wane. An intravenous infusion of a non-oxytocin containing solution should be started. Physiologic electrolyte solutions should be used except under unusual circumstances.

To prepare the usual solution for intravenous infusion–one mL (10 units) is combined aseptically with 1,000 mL of a non-hydrating diluent. The combined solution, rotated in the infusion bottle to insure thorough mixing, contains 10 mU/mL. Add the container with dilute oxytocic solution to the system through the use of a constant infusion pump or other such device to control accurately the rate of infusion.

The initial dose should be no more than 1 to 2 mU/min. The dose may be gradually increased in increments of no more than 1 to 2 mU/min., until a contraction pattern has been establis… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 108 words ▾

CONTRAINDICATIONS Oxytocin injection (synthetic) is contraindicated in any of the following conditions: • Significant cephalopelvic disproportion; • Unfavorable fetal positions or presentations which are undeliverable without conversion prior to delivery, i.e., transverse lies; • In obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention; • In cases of fetal distress where delivery is not imminent; • Prolonged use in uterine inertia or severe toxemia; • Hypertonic uterine patterns; • Patients with hypersensitivity to the drug; • Induction or augmentation of labor in those cases where vaginal delivery is contraindicated, such as cord presentation or prolapse, total placenta previa, and vasa previa.

⚠️ Warnings 28 words ▾

WARNINGS Oxytocin injection (synthetic) when given for induction or stimulation of labor, must be administered only by the intravenous route and with adequate medical supervision in a hospital.

🤒 Adverse Reactions 178 words ▾

ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following adverse reactions have been reported in the mother: • Anaphylactic reaction • Postpartum hemorrhage • Cardiac arrhythmia • Fatal afibrinogenemia • Nausea • Vomiting • Premature ventricular contractions • Pelvic hematoma Excessive dosage or hypersensitivity to the drug may result in uterine hypertonicity, spasm, tetanic contraction or rupture of the uterus.

The possibility of increased blood loss and afibrinogenemia should be kept in mind when administering the drug. Severe water intoxication with convulsions and coma has occurred and is associated with a slow oxytocin infusion over a 24-hour period. Maternal death due to oxytocin-induced water intoxication has been reported.

The following adverse reactions have been reported in the fetus or infant: Due to induced uterine mobility: • Bradycardia • Premature ventricular contractions and other arrhythmias • Permanent CNS or brain damage • Fetal death Due to use of oxytocin in the mother: • Neonatal retinal hemorrhage • Low Apgar scores at five minutes • Neonatal jaundice

🆘 Overdosage 115 words ▾

OVERDOSAGE Overdosage with oxytocin injection (synthetic) depends essentially on uterine hyperactivity whether or not due to hypersensitivity to this agent. Hyperstimulation with strong (hypertonic) or prolonged (tetanic) contractions, or a resting tone of 15 to 20 mm H 2 O or more between contractions can lead to tumultuous labor, uterine rupture, cervical and vaginal lacerations, postpartum hemorrhage, uteroplacental hypoperfusion and variable deceleration of fetal heart, fetal hypoxia, hypercapnia or death. Water intoxication with convulsions, which is caused by the inherent antidiuretic effect of oxytocin, is a serious complication that may occur if large doses (40 to 50 milliunits/minute) are infused for long periods.

Management consists of immediate discontinuation of oxytocin, and symptomatic and supportive therapy.

🧬 Clinical Pharmacology 92 words ▾

CLINICAL PHARMACOLOGY Oxytocin injection (synthetic) acts on the smooth muscle of the uterus to stimulate contractions; response depends on the uterine threshold of excitability. It exerts a selective action on the smooth musculature of the uterus, particularly toward the end of pregnancy, during labor and immediately following delivery. Oxytocin stimulates rhythmic contractions of the uterus, increases the frequency of existing contractions and raises the tone of the uterine musculature.

Synthetic oxytocin does not possess the cardiovascular effects, such as elevation of blood pressure, as exhibited by vasopressin found in posterior pituitary injection.

📦 How Supplied / Storage and Handling 84 words ▾

HOW SUPPLIED Oxytocin Injection, USP (synthetic) is supplied as follows: Product Code Unit of Sale Strength Each NP912011 NDC 63323-012-07 Unit of 25 10 USP Units per mL NDC 63323-012-17 1 mL fill in a 2 mL vial The container closure is not made with natural rubber latex. Discard unused content of vial. Use vial only if the solution is clear and the seal is intact.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not permit to freeze.

📋 Description 75 words ▾

DESCRIPTION Each mL of Oxytocin Injection, USP (synthetic), intended for intravenous infusion or intramuscular injection, possesses an oxytocic activity equivalent to 10 USP Oxytocin Units and contains chlorobutanol anhydrous (chloral derivative) 0.5%. This product may contain up to 12.5% decomposition products/impurities. Oxytocin injection (synthetic) is a sterile, clear, colorless solution of oxytocin in Water for Injection prepared by synthesis.

Acetic acid may have been added for pH adjustment (pH 3.0-5.0). The structural formula is: struc

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General All patients receiving intravenous oxytocin must be under continuous observation by trained personnel with a thorough knowledge of the drug and qualified to identify complications. A physician qualified to manage any complications should be immediately available. When properly administered, oxytocin should stimulate uterine contractions similar to those seen in normal labor.

Overstimulation of the uterus by improper administration can be hazardous to both mother and fetus. Even with proper administration and adequate supervision, hypertonic contractions can occur in patients whose uteri are hypersensitive to oxytocin. Except in unusual circumstances, oxytocin should not be administered in the following conditions: prematurity, borderline cephalopelvic disproportion, previous major surgery on the cervix or uterus including caesarean section, overdistention of the uterus, grand multiparity or invasive cervical carcinoma.

Because of the variability of the combinations of factors which may be present in the conditions above, the definition of ‘‘unusual circumstances’’ must be left to the judgement of the physician. The decision can only be made by carefully weighing the potential benefits which oxytocin can provide in a given case against rare but definite potential for the drug to produce hypertonicity or tetanic spasm. Maternal deaths due to hypertensive episodes, subarachnoid hemorrhage, rupture of the uterus and fetal deaths due to various causes have been reported associated with the use of parenteral oxytocic drugs for induction of labor and for augmentation in the first and second stages of labor.

Oxytocin has been shown to have an intrinsic antidiuretic effect, acting to increase water reabsorption from the glomerular filtrate. Consideration should, therefore, be given to the possibility of water intoxication, particularly when oxytocin is administered continuously by infusion and the patient is receiving fluids by mouth. Drug Interactions Severe hypertension has been reported when oxytocin was given three to four hours following prophylactic administration of a vasoconstrictor in conjunction with caudal block anesthesia.

Cyclopropane anesthesia may modify oxytocin’s cardiovascular effects, so as to produce unexpected results such as hypotension. Maternal sinus bradycardia with abnormal atrioventricular rhythms has also been noted when oxytocin was used concomitantly with cyclopropane anesthesia. Carcinogenesis, Mutagenesis, Impairment of Fertility There are no animal or human studies on the carcinogenicity and mutagenicity of this drug, nor is there any information on its effect on fertility.

Pregnancy Category C. There are no known indications for use of oxytocin in the first and second trimester of pregnancy other than in relation to spontaneous or induced abortion. Based on the wide experience with this drug and its chemical structure and pharmacological properties, it would not be expected to present a risk of fetal abnormalities when used as indicated.

Nonteratogenic Effects—See ADVERSE REACTIONS in the fetus or infant. Labor and Delivery—See INDICATIONS AND USAGE . Nursing Mothers It is not known whether this drug is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when oxytocin is administered to a nursing woman.

General All patients receiving intravenous oxytocin must be under continuous observation by trained personnel with a thorough knowledge of the drug and qualified to identify complications. A physician qualified to manage any complications should be immediately available. When properly administered, oxytocin should stimulate uterine contractions similar to those seen in normal labor.

Overstimulation of the uterus by improper administration can be hazardous to both mother and fetus. Even with proper administration and adequate supervision, hypertonic contractions can occur in patients whose uteri are hypersensitive to oxytocin. Except in… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 120 words ▾

PACKAGE LABEL - PRINCIPAL DISPLAY - Oxytocin 1 mL Vial Label NDC 63323-012-17 NP912011 OXYTOCIN INJECTION, USP (SYNTHETIC) For IV Infusion or IM Use 10 USP units per mL 1 mL Single Dose Vial Discard Unused Portion Rx only oxyto-label-01.jpg

PACKAGE LABEL - PRINCIPAL DISPLAY - Oxytocin 1 mL Vial Label NDC 63323-012-17 NP912011 OXYTOCIN INJECTION, USP (SYNTHETIC) For IV Infusion or IM Use 10 USP units per mL 1 mL Single Dose Vial Discard Unused Portion Rx only oxyto-label-02.jpg

PACKAGE LABEL - PRINCIPAL DISPLAY - Oxytocin 1 mL Vial Tray Label NDC 63323-012-07 NP912011 OXYTOCIN INJECTION, USP (SYNTHETIC) For IV Infusion or IM Use 10 USP units per mL 25 x 1 mL Single Dose Vials Rx only oxyto-label-03.jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
177
Units reimbursed last 4 qtrs
525
Latest quarter Q1 2026
28Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 177 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 525 units · 7.4 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
7.47.4
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Tennessee 7.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
25 vials63323-0012-11 711 Rx · $1,965
25 vials this page63323-0012-10 177 Rx
10 vials63323-0012-30 19 Rx
25 vials63323-0012-07 12 Rx
25 vials63323-0012-12 No Medicaid data
25 vials63323-0012-01 No Medicaid data
Drug total (last 4 qtrs): 919 Rx · 2,260 units · $1,965 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 5 other package presentations of this same product, including 10 vials (63323-0012-30), 25 vials (63323-0012-07), 25 vials (63323-0012-12). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Fresenius Kabi USA, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J2590 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 63323-0011-15 · Fresenius 63323-0013-26 · Fresenius →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.