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VASOPRESSIN 20 [USP'U]/mL Injection, Solution, 25 vials — NDC 65219-039-01 (Billing 65219-0039-01)

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

This is a package of 25 vials of VASOPRESSIN 20 [USP'U]/mL Injection, Solution from Fresenius Kabi USA, LLC, marketed since May 2023 and currently FDA-listed. It is this product's only package size.

NDC 65219-0039-01
🏷️ FDA NDC (as labeled) 65219-039-01 billing pads the product segment with a zero
Rx only Generic 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

⚠️
Other active recalls for Vasopressin (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jan 11, 2024 — Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit. (Par Sterile Products LLC) · FDA recall D-0232-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65219-039-01
Product NDC 65219-039
11-digit billing NDC 65219003901
NCPDP billing unit ML — per mL (volume)
RxCUI 2103182
UNII Y4907O6MFD
UPC 0365219039006
Application # ANDA213206
SPL Set ID 50aef1e8-0a70-466d-93cd-c1b9ed489839
Physiologic effect Vasoconstriction; Decreased Diuresis
Chemical class Vasopressins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-05-26
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance VASOPRESSIN
TE code (Orange Book) AP · RLD · RS

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

GCN Seq No 073081
GCN 37407
HICL code 002839
Ingredient (HICL) Vasopressin
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P2
Therapeutic class — intermediate (HIC2) Posterior Pituitary Hormones
HIC3 code P2B
Therapeutic class — specific (HIC3) Antidiuretic And Vasopressor Hormones
AHFS code 68:28.00.00
AHFS class Pituitary
FDB label name VASOPRESSIN 20 UNIT/ML VIAL
FDB brand name Vasopressin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 073081
  • GCN: 37407
  • HICL (First Databank): 002839
  • AHFS class code: 68:28.00.00
  • RxCUI (RxNorm): 2103182
Why two NDCs? The FDA registers this code as 65219-039-01 — 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 → 65219-0039-01. 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.

Clinical

Label name VASOPRESSIN 20 UNIT/ML VIAL Ingredient Vasopressin
📗 Our plain-language guide HelloPharmacist
  • It raises blood pressure in adults with vasodilatory shock, such as after heart surgery or with sepsis. It is used when fluids and other blood-pressure medicines have not been enou...
  • It is given through an IV drip in the hospital. Your team adjusts the rate in small steps to reach the right blood pressure, and then slowly tapers it down.
  • The most common ones include a slower or irregular heartbeat, lower heart output, low sodium, and reduced blood flow to areas like the gut, skin, fingers and toes. Your team monito...
  • Let them know about chest pain, belly pain, cold or discolored fingers or toes, unusual bleeding, or an allergic reaction. Your team also keeps an eye on your fluids and sodium aft...
📖 Read our full Vasopressin 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 · J2598 $0.490 / J2598 unit —
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)65219-039-01
11-digit billing NDC65219-0039-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ2598
DescriptorINJECTION, VASOPRESSIN, 1 UNIT
Billing units / pkg20 units
How the units are derivedThis package is 1 ML; the HCPCS unit is 1 U, so one package = 20 billing units.
Medicare Part B spend (2025 (Q1-Q4))$590 · 16 claims · $36.85 per claim (all NDCs under J2598)
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
65219-0039-01 You're viewing this Main listing 25 VIAL, SINGLE-DOSE in 1 TRAY / 1 mL in 1 VIAL, SINGLE-DOSE 2023-05-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Vasopressin 20 [USP'U]/mL 00517-1020-25 American 25 vials — — FDA listed —
Vasopressin 20 [USP'U]/mL 00548-9701-00 Amphastar 1 vial — AP FDA listed —
Vasopressin 20 [USP'U]/mL 25021-0474-01 Sagent 25 vials — AP FDA listed —
Vasostrict 20 [USP'U]/mL 42023-0164-10 Par 10 vials — AP FDA listed —
vasopressin 20 [USP'U]/mL 43598-0914-06 Dr. 25 vials — AP FDA listed —
Vasopressin 20 [USP'U]/mL 51662-1314-01 HF 1 ml — AP FDA listed —
Vasopressin 20 [USP'U]/mL 51662-1688-01 HF 1 ml — — FDA listed —
Vasopressin 20 [USP'U]/mL 63323-0930-01 Fresenius 25 vials — AP FDA listed —
Vasopressin 20 [USP'U]/mLthis 65219-0039-01 Fresenius 25 vials — AP FDA listed —
Vasopressin 20 [USP'U]/mL 68083-0520-10 Gland 10 vials — AP FDA listed —
vasopressin 20 [USP'U]/mL 70121-1642-02 Amneal 1 vial — AP FDA listed —
Vasostrict 20 [USP'U]/mL 71872-7264-01 Medical 1 vial — AP FDA listed —
vasopressin 20 [USP'U]/mL 71872-7334-01 Medical 1 vial — AP FDA listed —
Vasopressin 20 [USP'U]/mL 72572-0860-25 Civica, 25 vials — — FDA listed —
Vasopressin 20 [USP'U]/mL 55150-0370-01 Eugia 1 vial — AP FDA listed —
Vasopressin 20 [USP'U]/mL 71872-7306-01 Medical 1 vial — AP FDA listed —
Vasopressin 20 [USP'U]/mL 84549-0370-25 ProPharma 1 ml — AP FDA listed —
Vasopressin 20 [USP'U]/mL 00517-1030-01 American 1 vial — — FDA listed —
Vasopressin 20 [USP'U]/mL 51662-1682-01 HF 10 ml — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2023
On the market since
May 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 applicationANDA213206 (ANDA)
Labeler code65219
First marketedMay 2023
Product typeHuman Prescription Drug
Portfolio554 products on file
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. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 48 words ▾

1 INDICATIONS AND USAGE Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. • Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION • Dilute 20 units/mL single dose vial contents with normal saline (0.9% sodium chloride) or 5% dextrose in water (D5W) to either 0.1 units/mL or 1 unit/mL for intravenous administration. Discard unused diluted solution after 18 hours at room temperature or 24 hours under refrigeration. ( 2.1 ) • Post-cardiotomy shock: 0.03 to 0.1 units/minute ( 2.2 ) • Septic shock: 0.01 to 0.07 units/minute ( 2.2 )

2.1Preparation of Solution Inspect parenteral drug products for particulate matter and discoloration prior to use, whenever solution and container permit. Vasopressin Injection Solution for Dilution, 20 units/mL Dilute Vasopressin injection in normal saline (0.9% sodium chloride) or 5% dextrose in water (D5W) prior to use for intravenous administration. Discard unused diluted solution after 18 hours at room temperature or 24 hours under refrigeration.

Table 1 Preparation of diluted solutions Fluid restriction? Final concentration Mix Vasopressin injection Diluent No 0.1 units/mL 2.5 mL (50 units) 500 mL Yes 1 unit/mL 5 mL (100 units) 100 mL

2.2Administration In general, titrate to the lowest dose compatible with a clinically acceptable response. The recommended starting dose is: Post-cardiotomy shock: 0.03 units/minute Septic Shock: 0.01 units/minute Titrate up by 0.005 units/minute at 10- to 15-minute intervals until the target blood pressure is reached. There are limited data for doses above 0.1 units/minute for postcardiotomy shock and 0.07 units/minute for septic shock.

Adverse reactions are expected to increase with higher doses. After target blood pressure has been maintained for 8 hours without the use of catecholamines, taper vasopressin injection by 0.005 units/minute every hour as tolerated to maintain target blood pressure.

💊 Dosage Forms and Strengths 45 words ▾

3 DOSAGE FORMS AND STRENGTHS Vasopressin injection, USP is a clear, practically colorless solution available as 20 units/mL in a single dose vial. To be used after dilution. • Injection: 20 units/mL in a single dose vial. To be used after dilution. ( 3 )

⛔ Contraindications 60 words ▾

4 CONTRAINDICATIONS Vasopressin injection 1 mL single dose vial does not contain chlorobutanol and is therefore contraindicated only in patients with a known allergy or hypersensitivity to 8-L-arginine vasopressin. • Vasopressin injection 1 mL single dose vial does not contain chlorobutanol and is therefore contraindicated only in patients with a known allergy or hypersensitivity to 8-L-arginine vasopressin. ( 4 )

⚠️ Warnings and Cautions 91 words ▾

5 WARNINGS AND PRECAUTIONS • Can worsen cardiac function. ( 5.1 ) • Reversible diabetes insipidus ( 5.2 )

5.1Worsening Cardiac Function A decrease in cardiac index may be observed with the use of vasopressin.

5.2Reversible Diabetes Insipidus Patients may experience reversible diabetes insipidus, manifested by the development of polyuria, a dilute urine, and hypernatremia, after cessation of treatment with vasopressin. Monitor serum electrolytes, fluid status and urine output after vasopressin discontinuation. Some patients may require readministration of vasopressin or administration of desmopressin to correct fluid and electrolyte shifts.

🤒 Adverse Reactions 142 words ▾

6 ADVERSE REACTIONS The following adverse reactions associated with the use of vasopressin were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Bleeding/lymphatic system disorders: Hemorrhagic shock, decreased platelets, intractable bleeding Cardiac disorders: Right heart failure, atrial fibrillation, bradycardia, myocardial ischemia Gastrointestinal disorders: Mesenteric ischemia Hepatobiliary: Increased bilirubin levels Renal/urinary disorders: Acute renal insufficiency Vascular disorders: Distal limb ischemia Metabolic: Hyponatremia Skin: Ischemic lesions Postmarketing Experience Reversible diabetes insipidus [see Warnings and Precautions ( 5.2 )] .

The most common adverse reactions include decreased cardiac output, bradycardia, tachyarrhythmias, hyponatremia and ischemia (coronary, mesenteric, skin, digital). ( 6 ) 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.

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS • Pressor effects of catecholamines and Vasopressin injection are expected to be additive. ( 7.1 ) • Indomethacin may prolong effects of Vasopressin injection. ( 7.2 ) • Co-administration of ganglionic blockers or drugs causing SIADH may increase the pressor response. ( 7.3 , 7.4 ) • Co-administration of drugs causing diabetes insipidus may decrease the pressor response. ( 7.5 )

7.1Catecholamines Use with catecholamines is expected to result in an additive effect on mean arterial blood pressure and other hemodynamic parameters. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed.

7.2Indomethacin Use with indomethacin may prolong the effect of Vasopressin injection on cardiac index and systemic vascular resistance. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed [see Clinical Pharmacology ( 12.3 )].

7.3Ganglionic Blocking Agents Use with ganglionic blocking agents may increase the effect of Vasopressin injection on mean arterial blood pressure. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed [see Clinical Pharmacology ( 12.3 )].

7.4Drugs Suspected of Causing SIADH Use with drugs suspected of causing SIADH (e.g., SSRIs, tricyclic antidepressants, haloperidol, chlorpropamide, enalapril, methyldopa, pentamidine, vincristine, cyclophosphamide, ifosfamide, felbamate) may increase the pressor effect in addition to the antidiuretic effect of Vasopressin injection. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed.

7.5Drugs Suspected of Causing Diabetes Insipidus Use with drugs suspected of causing diabetes insipidus (e.g., demeclocycline, lithium, foscarnet, clozapine) may decrease the pressor effect in addition to the antidiuretic effect of Vasopressin injection. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy: May induce uterine contractions. ( 8.1 ) • Pediatric Use: Safety and effectiveness have not been established. ( 8.4 ) • Geriatric Use: No safety issues have been identified in older patients. ( 8.5 )

8.1Pregnancy Risk Summary There are no available data on Vasopressin injection use in pregnant women to inform a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted. Clinical Considerations Dose adjustments during pregnancy and the postpartum period: Because of increased clearance of vasopressin in the second and third trimester, the dose of Vasopressin injection may need to be increased [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )].

Maternal adverse reactions: Vasopressin injection may produce tonic uterine contractions that could threaten the continuation of pregnancy.

8.2Lactation There are no data on the presence of vasopressin injection in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.

8.4Pediatric Use Safety and effectiveness of Vasopressin injection in pediatric patients with vasodilatory shock have not been established.

8.5Geriatric Use Clinical studies of vasopressin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Warnings and Precautions ( 5 ), Adverse Reactions ( 6 ), and Clinical Pharmacology ( 12.3 )] .

🤰 Pregnancy 102 words ▾

8.1Pregnancy Risk Summary There are no available data on Vasopressin injection use in pregnant women to inform a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted. Clinical Considerations Dose adjustments during pregnancy and the postpartum period: Because of increased clearance of vasopressin in the second and third trimester, the dose of Vasopressin injection may need to be increased [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )].

Maternal adverse reactions: Vasopressin injection may produce tonic uterine contractions that could threaten the continuation of pregnancy.

🧒 Pediatric Use 19 words ▾

8.4Pediatric Use Safety and effectiveness of Vasopressin injection in pediatric patients with vasodilatory shock have not been established.

🧓 Geriatric Use 102 words ▾

8.5Geriatric Use Clinical studies of vasopressin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Warnings and Precautions ( 5 ), Adverse Reactions ( 6 ), and Clinical Pharmacology ( 12.3 )] .

🆘 Overdosage 55 words ▾

10 OVERDOSAGE Overdosage with Vasopressin injection can be expected to manifest as consequences of vasoconstriction of various vascular beds (peripheral, mesenteric, and coronary) and as hyponatremia. In addition, overdosage may lead less commonly to ventricular tachyarrhythmias (including Torsade de Pointes), rhabdomyolysis, and nonspecific gastrointestinal symptoms. Direct effects will resolve within minutes of withdrawal of treatment.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Vasopressin causes vasoconstriction by binding to V 1 receptors on vascular smooth muscle coupled to the Gq/1 1-phospholipase C-phosphatidyl-inositol-triphosphate pathway, resulting in the release of intracellular calcium. In addition, vasopressin stimulates antidiuresis via stimulation of V 2 receptors which are coupled to adenyl cyclase.

12.2Pharmacodynamics At therapeutic doses exogenous vasopressin elicits a vasoconstrictive effect in most vascular beds including the splanchnic, renal and cutaneous circulation. In addition, vasopressin at pressor doses triggers contractions of smooth muscles in the gastrointestinal tract mediated by muscular V 1 -receptors and release of prolactin and ACTH via V 3 receptors. At lower concentrations typical for the antidiuretic hormone vasopressin inhibits water diuresis via renal V 2 receptors.

In addition, vasopressin has been demonstrated to cause vasodilation in numerous vascular beds that are mediated by V 2 , V 3 , oxytocin and purinergic P2 receptors. In patients with vasodilatory shock vasopressin in therapeutic doses increases systemic vascular resistance and mean arterial blood pressure and reduces the dose requirements for norepinephrine. Vasopressin tends to decrease heart rate and cardiac output.

The pressor effect is proportional to the infusion rate of exogenous vasopressin. The pressor effect reaches its peak within 15 minutes. After stopping the infusion the pressor effect fades within 20 minutes.

There is no evidence for tachyphylaxis or tolerance to the pressor effect of vasopressin in patients.

12.3Pharmacokinetics Vasopressin plasma concentrations increase linearly with increasing infusion rates from 10 to 200 μU/kg/min. Steady state plasma concentrations are achieved after 30 minutes of continuous intravenous infusion. Distribution Vasopressin does not appear to bind plasma protein.

The volume of distribution is 140 mL/kg. Elimination At infusion rates used in vasodilatory shock (0.01 to 0.1 units/minute), the clearance of vasopressin is 9 to 25 mL/min/kg in patients with vasodilatory shock. The apparent t 1/2 of vasopressin at these levels is ≤ 10 minutes.

Metabolism Serine protease, carboxipeptidase and disulfide oxido-reductase cleave vasopressin at sites relevant for the pharmacological activity of the hormone. Thus, the generated metabolites are not expected to retain important pharmacological activity. Excretion Vasopressin is predominantly metabolized and only about 6% of the dose is excreted unchanged into urine.

Specific Populations Pregnancy: Because of a spillover into blood of placental vasopressinase, the clearance of exogenous and endogenous vasopressin increases gradually over the course of a pregnancy. During the first trimester of pregnancy, the clearance is only slightly increased. However, by the third trimester the clearance of vasopressin is increased about 4-fold and at term up to 5-fold.

After delivery, the clearance of vasopressin returns to preconception baseline within two weeks. Drug Interactions Indomethacin more than doubles the time to offset for vasopressin's effect on peripheral vascular resistance and cardiac output in healthy subjects [see Drug Interactions ( 7.2 )]. The ganglionic blocking agent tetra-ethylammonium increases the pressor effect of vasopressin by 20% in healthy subjects [see Drug Interactions ( 7.3 )].

Halothane, morphine, fentanyl, alfentanyl and sufentanyl do not impact exposure to endogenous vasopressin.

🧬 Mechanism of Action 48 words ▾

12.1Mechanism of Action Vasopressin causes vasoconstriction by binding to V 1 receptors on vascular smooth muscle coupled to the Gq/1 1-phospholipase C-phosphatidyl-inositol-triphosphate pathway, resulting in the release of intracellular calcium. In addition, vasopressin stimulates antidiuresis via stimulation of V 2 receptors which are coupled to adenyl cyclase.

📦 How Supplied / Storage and Handling 200 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Vasopressin injection, USP is a clear, practically colorless solution for intravenous administration available as: Product Code Unit of Sale Strength Unit of Use RF930101 NDC 65219-039-01 A tray of 25 Single Dose Vials 20 Units per 1 mL NDC 65219-039-00 1 mL Single Dose Vial Store between 2°C and 8°C (36°F and 46°F). Do not freeze. Vials may be held up to 12 months upon removal from refrigeration to room temperature storage conditions (20°C to 25°C [68°F to 77°F], [see USP Controlled Room Temperature]), anytime within the labeled shelf life.

Once removed from refrigeration, unopened vial should be marked to indicate the revised 12 month expiration date. If the manufacturer's original expiration date is shorter than the revised expiration date, then the shorter date must be used. Do not use Vasopressin injection beyond the manufacturer's expiration date stamped on the vial.

The storage conditions and expiration periods are summarized in the following table. Unopened Refrigerated 2°C to 8°C (36°F to 46°F) Unopened Room Temperature 20°C to 25°C (68°F to 77°F) Do not store above 25°C (77°F) 1 mL Vial Until manufacturer expiration date 12 months or until manufacturer expiration date, whichever is earlier 451491A Figure

📋 Description 81 words ▾

11 DESCRIPTION Vasopressin is a polypeptide hormone. Vasopressin injection is a sterile, aqueous solution of synthetic arginine vasopressin for intravenous administration. The 1 mL solution contains vasopressin 20 units/mL, 1.36 mg sodium acetate buffer and Water for Injection, USP.

Sodium hydroxide and hydrochloric acid are included to adjust to a pH of 3.8. The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl-L-Glutaminyl- L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water.

The structural formula is: Structural Formula

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Vasopressin plasma concentrations increase linearly with increasing infusion rates from 10 to 200 μU/kg/min. Steady state plasma concentrations are achieved after 30 minutes of continuous intravenous infusion. Distribution Vasopressin does not appear to bind plasma protein.

The volume of distribution is 140 mL/kg. Elimination At infusion rates used in vasodilatory shock (0.01 to 0.1 units/minute), the clearance of vasopressin is 9 to 25 mL/min/kg in patients with vasodilatory shock. The apparent t 1/2 of vasopressin at these levels is ≤ 10 minutes.

Metabolism Serine protease, carboxipeptidase and disulfide oxido-reductase cleave vasopressin at sites relevant for the pharmacological activity of the hormone. Thus, the generated metabolites are not expected to retain important pharmacological activity. Excretion Vasopressin is predominantly metabolized and only about 6% of the dose is excreted unchanged into urine.

Specific Populations Pregnancy: Because of a spillover into blood of placental vasopressinase, the clearance of exogenous and endogenous vasopressin increases gradually over the course of a pregnancy. During the first trimester of pregnancy, the clearance is only slightly increased. However, by the third trimester the clearance of vasopressin is increased about 4-fold and at term up to 5-fold.

After delivery, the clearance of vasopressin returns to preconception baseline within two weeks. Drug Interactions Indomethacin more than doubles the time to offset for vasopressin's effect on peripheral vascular resistance and cardiac output in healthy subjects [see Drug Interactions ( 7.2 )]. The ganglionic blocking agent tetra-ethylammonium increases the pressor effect of vasopressin by 20% in healthy subjects [see Drug Interactions ( 7.3 )].

Halothane, morphine, fentanyl, alfentanyl and sufentanyl do not impact exposure to endogenous vasopressin.

🧬 Pharmacodynamics 180 words ▾

12.2Pharmacodynamics At therapeutic doses exogenous vasopressin elicits a vasoconstrictive effect in most vascular beds including the splanchnic, renal and cutaneous circulation. In addition, vasopressin at pressor doses triggers contractions of smooth muscles in the gastrointestinal tract mediated by muscular V 1 -receptors and release of prolactin and ACTH via V 3 receptors. At lower concentrations typical for the antidiuretic hormone vasopressin inhibits water diuresis via renal V 2 receptors.

In addition, vasopressin has been demonstrated to cause vasodilation in numerous vascular beds that are mediated by V 2 , V 3 , oxytocin and purinergic P2 receptors. In patients with vasodilatory shock vasopressin in therapeutic doses increases systemic vascular resistance and mean arterial blood pressure and reduces the dose requirements for norepinephrine. Vasopressin tends to decrease heart rate and cardiac output.

The pressor effect is proportional to the infusion rate of exogenous vasopressin. The pressor effect reaches its peak within 15 minutes. After stopping the infusion the pressor effect fades within 20 minutes.

There is no evidence for tachyphylaxis or tolerance to the pressor effect of vasopressin in patients.

🔬 Clinical Studies 28 words ▾

14 CLINICAL STUDIES Increases in systolic and mean blood pressure following administration of vasopressin were observed in 7 studies in septic shock and 8 in post-cardiotomy vasodilatory shock.

🧪 Nonclinical Toxicology 77 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No formal carcinogenicity or fertility studies with vasopressin have been conducted in animals. Vasopressin was found to be negative in the in vitro bacterial mutagenicity (Ames) test and the in vitro Chinese hamster ovary (CHO) cell chromosome aberration test. In mice, vasopressin has been reported to have an effect on function and fertilizing ability of spermatozoa.

13.2Animal Toxicology and/or Pharmacology No toxicology studies were conducted with vasopressin.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 62 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No formal carcinogenicity or fertility studies with vasopressin have been conducted in animals. Vasopressin was found to be negative in the in vitro bacterial mutagenicity (Ames) test and the in vitro Chinese hamster ovary (CHO) cell chromosome aberration test. In mice, vasopressin has been reported to have an effect on function and fertilizing ability of spermatozoa.

📄 Package Label / Principal Display Panel 147 words ▾

PACKAGE LABEL- PRINCIPAL DISPLAY PANEL- VASOPRESSIN INJECTION 20 Unit Tray Label NDC 65219-039-01 Rx Only Vasopressin Injection, USP 20 Units per mL For Intravenous Infusion Must be diluted prior to use Store between 2°C and 8°C (36°F and 46°F). Vials may be held at 20°C to 25°C (68°F to 77°F) for up to 12 months. Do not store above 25°C (77°F).

Avoid freezing. 25 x 1 mL Single Dose Vials PACKAGE LABEL- PRINCIPAL DISPLAY PANEL- VASOPRESSIN INJECTION 20 Unit Tray Label

PACKAGE LABEL- PRINCIPAL DISPLAY PANEL- VASOPRESSIN INJECTION 20 Unit Vial Label NDC 65219-039-00 +RFID)) Vasopressin Injection, USP 20 Units per mL For Intravenous Infusion Must be diluted prior to use. Usual Dosage: See insert. Store between 2°C and 8°C (36°F and 46°F). Do not store above 25°C (77°F) 1 mL Single Dose Vial Rx Only PACKAGE LABEL- PRINCIPAL DISPLAY PANEL- VASOPRESSIN INJECTION 20 Unit Vial Label

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

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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
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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.
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 J2598 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.
← 65219-0029-20 · Fresenius 65219-0042-71 · Fresenius →
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