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Vasostrict Vasopressin 20 [USP'U]/mL Injection, 25 vials — NDC 42023-164-83 (Billing 42023-0164-83)

by Par Health USA, LLC · 25 VIAL in 1 CARTON / 1 mL in 1 VIAL

This is a package of 25 vials of Vasostrict Vasopressin 20 [USP'U]/mL Injection from Par Health USA, LLC, marketed since Dec 2022 and currently FDA-listed.

NDC 42023-0164-83
🏷️ FDA NDC (as labeled) 42023-164-83 billing pads the product segment with a zero
This package
Contains25 vials Pack sizes3 compare ↓
Product page 42023-0164-25 Also comes in: 10 vials 42023-164-10 25 vials 42023-164-25
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

🚨
Active recall for this product.
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
Lots / codes: Lot # 66702; Exp. 02/2025 · reported Jan 24, 2024
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 42023-164-83
Product NDC 42023-164
11-digit billing NDC 42023016483
NCPDP billing unit ML — per mL (volume)
RxCUI 2103182, 2103184
UNII Y87Y826H08
Application # NDA204485
SPL Set ID b97e5c3e-ca28-4ffa-80af-6c5bdbadaf10
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-12-05
Route INTRAVENOUS
Dosage form INJECTION
Substance VASOPRESSIN, UNSPECIFIED
TE code (Orange Book) AP · RLD · RS

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

GPI-14 30201030002015
GPI class Vasostrict
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 VASOSTRICT 20 UNIT/ML VIAL
FDB brand name Vasostrict
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 073081
  • GCN: 37407
  • GPI-14 (Medi-Span): 30201030002015
  • HICL (First Databank): 002839
  • AHFS class code: 68:28.00.00
  • RxCUI (RxNorm): 2103182
Why two NDCs? The FDA registers this code as 42023-164-83 — 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 → 42023-0164-83. 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 VASOSTRICT 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 eachPer 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)42023-164-83
11-digit billing NDC42023-0164-83
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
42023-0164-10 42023-164-10 10 VIAL in 1 CARTON / 1 mL in 1 VIAL 2020-08-17 — Active
42023-0164-25 42023-164-25 Main listing 25 VIAL in 1 CARTON / 1 mL in 1 VIAL 2014-11-12 — Active
42023-0164-83 You're viewing this 25 VIAL in 1 CARTON / 1 mL in 1 VIAL 2022-12-05 — 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 this package?
This package contains 25 vials — 25 vial in 1 carton / 1 ml in 1 vial.
How does this package differ from NDC 42023-0164-10?
Both are Vasostrict Vasopressin 20 [USP'U]/mL Injection — the drug itself is identical. This page's package is the 25 vials one, while NDC 42023-0164-10 is the 10 vials package.
What NDC number is used to bill for this package of Vasostrict Vasopressin 20 [USP'U]/mL Injection?
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
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]/mLthis 42023-0164-83 Par 25 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]/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 —
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

🏛️
2014
First FDA approval
Apr 2014
📍
2026
Currently FDA-listed
12 years listed
🛡️
2035
Latest patent/protection listed
not a guaranteed launch date
🔒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.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jan 2035. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 17, 2014 AP TE-rated RLD RS ⏳ ~8.3 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9375478 — method of use (U-1857)
US 9744209 — method of use (U-1857)
US 9375478 — method of use (U-1857)
US 9937223 — method of use (U-1857)
US 9744239 — method of use (U-1857)
US 10010575 — method of use (U-1857)
US 9981006 — method of use (U-1857)
US 9974827 — method of use (U-1857)
US 9968649 — method of use (U-1857)
US 9962422 — method of use (U-1857)
US 9925234 — method of use (U-1857)
US 9925233 — method of use (U-1857)
US 9962422 — method of use (U-1857)
US 9981006 — method of use (U-1857)
US 9974827 — method of use (U-1857)
US 9968649 — method of use (U-1857)
US 9925233 — method of use (U-1857)
US 9925234 — method of use (U-1857)
US 10010575 — method of use (U-1857)
US 9744239 — method of use (U-1857)
US 9744209 — method of use (U-1857)
US 10010575 — method of use (U-1857)
US 9925233 — method of use (U-1857)
US 9925233 — method of use (U-1857)
US 10010575 — method of use (U-1857)
US 9974827 — method of use (U-1857)
US 9968649 — method of use (U-1857)
US 9962422 — method of use (U-1857)
US 9925234 — method of use (U-1857)
US 9981006 — method of use (U-1857)
US 9968649 — method of use (U-1857)
US 9925234 — method of use (U-1857)
US 9962422 — method of use (U-1857)
US 9974827 — method of use (U-1857)
US 9981006 — method of use (U-1857)
US 9687526 — method of use (U-1857)
US 9687526 — method of use (U-1857)
US 12186362 — drug product
US 12186362 — drug product
US 9919026 — drug product
US 9919026 — drug product
US 9919026 — drug product
US 9919026 — drug product
US 9750785 — drug product
US 9750785 — drug product
US 12186362 — drug product
US 12186362 — drug product
2014 2016 2018 2020 2022 2024 2026 2028 2030 2032 2034
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (47)
PatentTypeUse codeExpires
US 9375478 ↗ Method of use U-1857 Jan 30, 2035
US 9744209 ↗ Method of use U-1857 Jan 30, 2035
US 9375478 ↗ Method of use U-1857 Jan 30, 2035
US 9937223 ↗ Method of use U-1857 Jan 30, 2035
US 9744239 ↗ Method of use U-1857 Jan 30, 2035
US 10010575 ↗ Method of use U-1857 Jan 30, 2035
US 9981006 ↗ Method of use U-1857 Jan 30, 2035
US 9974827 ↗ Method of use U-1857 Jan 30, 2035
US 9968649 ↗ Method of use U-1857 Jan 30, 2035
US 9962422 ↗ Method of use U-1857 Jan 30, 2035
US 9925234 ↗ Method of use U-1857 Jan 30, 2035
US 9925233 ↗ Method of use U-1857 Jan 30, 2035
US 9962422 ↗ Method of use U-1857 Jan 30, 2035
US 9981006 ↗ Method of use U-1857 Jan 30, 2035
US 9974827 ↗ Method of use U-1857 Jan 30, 2035
US 9968649 ↗ Method of use U-1857 Jan 30, 2035
US 9925233 ↗ Method of use U-1857 Jan 30, 2035
US 9925234 ↗ Method of use U-1857 Jan 30, 2035
US 10010575 ↗ Method of use U-1857 Jan 30, 2035
US 9744239 ↗ Method of use U-1857 Jan 30, 2035
US 9744209 ↗ Method of use U-1857 Jan 30, 2035
US 10010575 ↗ Method of use U-1857 Jan 30, 2035
US 9925233 ↗ Method of use U-1857 Jan 30, 2035
US 9925233 ↗ Method of use U-1857 Jan 30, 2035
US 10010575 ↗ Method of use U-1857 Jan 30, 2035
US 9974827 ↗ Method of use U-1857 Jan 30, 2035
US 9968649 ↗ Method of use U-1857 Jan 30, 2035
US 9962422 ↗ Method of use U-1857 Jan 30, 2035
US 9925234 ↗ Method of use U-1857 Jan 30, 2035
US 9981006 ↗ Method of use U-1857 Jan 30, 2035
US 9968649 ↗ Method of use U-1857 Jan 30, 2035
US 9925234 ↗ Method of use U-1857 Jan 30, 2035
US 9962422 ↗ Method of use U-1857 Jan 30, 2035
US 9974827 ↗ Method of use U-1857 Jan 30, 2035
US 9981006 ↗ Method of use U-1857 Jan 30, 2035
US 9687526 ↗ Method of use U-1857 Jan 30, 2035
US 9687526 ↗ Method of use U-1857 Jan 30, 2035
US 12186362 ↗ Drug product — Jan 30, 2035
US 12186362 ↗ Drug product — Jan 30, 2035
US 9919026 ↗ Drug product — Jan 30, 2035
US 9919026 ↗ Drug product — Jan 30, 2035
US 9919026 ↗ Drug product — Jan 30, 2035
US 9919026 ↗ Drug product — Jan 30, 2035
US 9750785 ↗ Drug product — Jan 30, 2035
US 9750785 ↗ Drug product — Jan 30, 2035
US 12186362 ↗ Drug product — Jan 30, 2035
US 12186362 ↗ Drug product — Jan 30, 2035
Common questions
Is there a generic version of VASOSTRICT 20 UNIT/ML VIAL?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for VASOSTRICT 20 UNIT/ML VIAL. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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

LabelerPar Health USA, LLC
Application holderPH HEALTH LTD
FDA applicationNDA204485 (NDA)
Labeler code42023
First marketedDec 2022
Product typeHuman Prescription Drug
Portfolio216 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 📦 Storage and Handling 📋 Description 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 47 words ▾

1 INDICATIONS AND USAGE Vasostrict ® is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. Vasostrict ® 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 or 200 units/10 mL (20 units/mL) multiple 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. Vasostrict ® Solution for Dilution, 20 units/mL and 200 units/10 mL (20 units/mL) Dilute Vasostrict ® 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 Vasostrict ® 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 68 words ▾

3 DOSAGE FORMS AND STRENGTHS Vasostrict ® (vasopressin injection, USP) is a clear, practically colorless solution available as 20 units/mL in a single dose vial and 200 units/10 mL (20 units/mL) in a multiple dose vial. To be used after dilution. Injection: 20 units/mL in a single dose vial and 200 units/10 mL (20 units/mL) in a multiple dose vial. To be used after dilution. ( 3 )

⛔ Contraindications 99 words ▾

4 CONTRAINDICATIONS Vasostrict ® 10 mL multiple dose vial is contraindicated in patients with known allergy or hypersensitivity to 8‑L-arginine vasopressin or chlorobutanol. The 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. Vasostrict ® 10 mL multiple dose vial is contraindicated in patients with known allergy or hypersensitivity to 8‑L-arginine vasopressin or chlorobutanol.

The 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 89 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 138 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 Par Health at 1-800-828-9393 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 Vasostrict ® are expected to be additive. ( 7.1 ) Indomethacin may prolong effects of Vasostrict ® . ( 7.2 ) Co-administration of ganglionic blockers or drugs causing SIADH may increase the pressor response. ( 7.3 , 7.5 ) Co-administration of drugs causing diabetes insipidus may decrease the pressor response. (7.6)

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 Vasostrict ® 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 Vasostrict ® 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 Vasostrict ® . 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 Vasostrict ® . 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 Vasostrict ® 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 Vasostrict ® may need to be increased [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) ] .

Maternal adverse reactions: Vasostrict ® 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 Vasostrict ® 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 101 words ▾

8.1Pregnancy Risk Summary There are no available data on Vasostrict ® 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 Vasostrict ® may need to be increased [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) ] .

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

🧒 Pediatric Use 19 words ▾

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

🧓 Geriatric Use 99 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 Vasostrict ® 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 ~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/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 P 2 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 pre-conception 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 47 words ▾

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 ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Vasostrict ® (vasopressin injection, USP) is a clear, practically colorless solution for intravenous administration available as: NDC 42023-164-85: A carton of 10 single dose vials. Each vial contains vasopressin 1 mL at 20 units/mL. NDC 42023-164-83: A carton of 25 single dose vials.

Each vial contains vasopressin 1 mL at 20 units/mL. NDC 42023-190-89: A carton of 1 multiple dose vial. Each vial contains vasopressin 10 mL at 200 units/10 mL (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], 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 Vasostrict ® beyond the manufacturer’s expiration date stamped on the vial.

After initial entry into the 10 mL vial, the remaining contents must be refrigerated. Discard the refrigerated 10 mL vial after 30 days after first puncture. 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 Puncture) 1 mL Vial Until manufacturer expiration date 12 months or until manufacturer expiration date, whichever is earlier N/A 10 mL Vial Until manufacturer expiration date 12 months or until manufacturer expiration date, whichever is earlier 30 days

📦 Storage and Handling 197 words ▾

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], 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 Vasostrict ® beyond the manufacturer’s expiration date stamped on the vial.

After initial entry into the 10 mL vial, the remaining contents must be refrigerated. Discard the refrigerated 10 mL vial after 30 days after first puncture. 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 Puncture) 1 mL Vial Until manufacturer expiration date 12 months or until manufacturer expiration date, whichever is earlier N/A 10 mL Vial Until manufacturer expiration date 12 months or until manufacturer expiration date, whichever is earlier 30 days

📋 Description 126 words ▾

11 DESCRIPTION Vasopressin is a polypeptide hormone. Vasostrict ® 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.

The 10 mL solution contains vasopressin 20 units/mL, 1.36 mg sodium acetate buffer, chlorobutanol, NF 0.5% as a preservative 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: Molecular Formula: C 46 H 65 N 15 O 12 S 2 Molecular Weight: 1084.23 One mg is equivalent to 530 units. Chemical Structure

🧬 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 pre-conception 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 181 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 P 2 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 11 words ▾

PRINCIPAL DISPLAY PANEL - 20 units/mL x 25 Vial Carton Carton

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

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 vials42023-0164-25 553 Rx · $116,380
10 vials42023-0164-10 134 Rx · $495
25 vials this page42023-0164-83 No Medicaid data
Drug total (last 4 qtrs): 687 Rx · 1,767 units · $116,875 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 — 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
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 Par Health 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 2 other package presentations of this same product, including 10 vials (42023-0164-10), 25 vials (42023-0164-25). 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?
Par Health 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.
← 42023-0159-25 · Par 42023-0168-01 · Par →
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.