![Oxytocin 10 [USP'U]/mL Injection, Solution, 25 vials — NDC 63323-0012-01 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6d7d1280-f286-4f39-89f3-2b96571810e6&name=oxyto-label-01.jpg)
Oxytocin 10 [USP'U]/mL Injection, Solution, 25 vials
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Oxytocic class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
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 ↗- That's a really common question. Oxytocin is used when there's a medical reason to start or speed up labor — for example, if your water has broken and contractions haven't started,...
- Why am I being given oxytocin? I thought labor was supposed to start on its own.
- For starting or strengthening labor, oxytocin is always given through an IV drip in your arm using a pump that carefully controls the flow rate. Your contractions and your baby's h...
- The most common ones are nausea and vomiting. Your heart rate and blood pressure will be watched for any changes. If the contractions become too strong or too frequent, that's some...
Patient education
Supplement & herbal interactions
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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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.
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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.
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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?
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
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💲 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 system | Per mL | Per 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. | |
Where does this data come from?
🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 63323-0012-01 | 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 | — |
Where does this data come from?
⏳ Availability & generic status
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?
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63323-0012-07 | 25 VIAL in 1 TRAY (63323-012-07) / 1 mL in 1 VIAL (63323-012-17) | 2019-11-08 | Active |
| 63323-0012-12 | 25 VIAL in 1 TRAY (63323-012-12) / 1 mL in 1 VIAL (63323-012-21) | 2000-08-10 | Active |
| 63323-0012-01 You're viewing this | 25 VIAL in 1 TRAY (63323-012-01) / 1 mL in 1 VIAL (63323-012-00) | 2000-08-10 | Active |
| 63323-0012-10 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-012-10) / 10 mL in 1 VIAL, MULTI-DOSE (63323-012-06) | 2000-08-10 | Active |
| 63323-0012-11 | 25 VIAL in 1 TRAY (63323-012-11) / 1 mL in 1 VIAL (63323-012-03) | 2000-08-10 | Active |
| 63323-0012-30 | 10 VIAL, MULTI-DOSE in 1 TRAY (63323-012-30) / 30 mL in 1 VIAL, MULTI-DOSE (63323-012-02) | 2000-08-10 | Active |
This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 63323-0012-01?
What is the difference between NDC 63323-0012-01 and NDC 63323-0012-07?
What NDC number is used to bill for this package of Oxytocin 10 [USP'U]/mL Injection, Solution?
🧭 About this NDC listing & data coverage
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) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 ▾
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…
⛔ Contraindications ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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