![vasopressin 20 [USP'U]/mL Injection, 25 vials — NDC 43598-0914-25 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=caf04d72-679e-daf9-e86f-4867f83b8ac5&name=carton25.jpg)
vasopressin 20 [USP'U]/mL Injection, 25 vials
Other active recalls for Vasopressin (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- Vasopressin is being used to raise dangerously low blood pressure caused by a condition called vasodilatory shock — where blood vessels have relaxed too much and other treatments l...
- What exactly is vasopressin being used for in my (or my family member's) care?
- Vasopressin is given as a slow, continuous drip through an IV line — you won't take it by mouth or inject it yourself. The clinical team starts at a low rate and gradually adjusts...
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Patient education
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🧪 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 QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 4550K0SC9B
Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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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.
4 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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.0675 | $1.69 / 25 vials |
| 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?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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]/mLthis 43598-0914-25 | Dr. | 25 vials | — | AP | Discontinued | — |
| 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]/mL 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 | — |
| Vasostrict 20 [USP'U]/mL 71872-7014-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Vasopressin 20 [USP'U]/mL 51662-1623-01 | HF | 1 ml | — | AP | FDA listed | — |
| Vasostrict 20 [USP'U]/mL 42023-0190-01 | Par | 1 vial | — | AP | FDA listed | — |
| Vasopressin 20 [USP'U]/mL 51662-1694-02 | HF | 1 vial | — | AP | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 43598-0914-06 | 25 VIAL in 1 CARTON (43598-914-06) / 1 mL in 1 VIAL (43598-914-11) | 2024-09-05 | Active |
| 43598-0914-25 You're viewing this | 25 VIAL in 1 CARTON (43598-914-25) / 1 mL in 1 VIAL (43598-914-11) | 2024-05-09 | Discontinued by firm |
This pack accounts for about 27% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 43598-0914-25?
What is the difference between NDC 43598-0914-25 and NDC 43598-0914-06?
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🧭 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) | ✓ Available |
Questions about this listing
Why is there no price listed?
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 ▾
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 V asopressin 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 post-cardiotomy 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 ▾
3 DOSAGE FORMS AND STRENGTHS Vasopressin injection, USP is a colorless solution for intravenous administration available as 20 units/mL in a single dose vial. To be used after dilution. Injection: 20 units per mL in a single dose vial. To be used after dilution. ( 3 )
⛔ Contraindications ▾
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 ▾
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 ▾
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 Dr. Reddy’s Laboratories Inc. at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
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 ▾
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 with vasopressin. 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 ▾
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 with vasopressin. 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 ▾
8.4Pediatric Use Safety and effectiveness of vasopressin injection in pediatric patients with vasodilatory shock have not been established.
🧓 Geriatric Use ▾
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 ▾
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 non-specific gastrointestinal symptoms. Direct effects will resolve within minutes of withdrawal of treatment.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Vasopressin causes vasoconstriction by binding to V 1 receptors on vascular smooth muscle coupled to the Gq/11-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 ▾
12.1Mechanism of Action Vasopressin causes vasoconstriction by binding to V 1 receptors on vascular smooth muscle coupled to the Gq/11-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 ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Vasopressin injection, USP is a clear, colorless solution for intravenous administration available as: NDC 43598-914-06: A carton of 25 single dose vials. Each vial contains vasopressin, USP 1 mL at 20 units/mL. 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 months 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, USP 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) Opened (After First Pun cture) 1 mL Vial Until manufacturerexpiration date 12 months or until manufacturer expiration date,whichever is earlier N/A
📦 Storage and Handling ▾
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 months 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, USP 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) Opened (After First Pun cture) 1 mL Vial Until manufacturerexpiration date 12 months or until manufacturer expiration date,whichever is earlier N/A
📋 Description ▾
11 DESCRIPTION Vasopressin is a polypeptide hormone. Vasopressin injection, USP is a sterile, aqueous solution of synthetic arginine vasopressin for intravenous administration. The 1 mL solution contains vasopressin, USP 20 units/mL, 1.36 mg sodium acetate trihydrate 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-PhenylalanylL-Glutaminyl-L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off white powder/flakes, freely soluble in water.
The structural formula is: Molecular Formula: C 46 H 65 N 15 O 12 S 2 Molecular Weight: 1084.24 u One mg is equivalent to 530 units. Chemical Structure