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Phentolamine Mesylate 5 mg/mL Injection, Powder, For Solution, 1 vial — NDC 0143-9564-01 (Billing 00143-9564-01)

by Hikma Pharmaceuticals USA Inc. · 1 VIAL in 1 BOX / 1 mL in 1 VIAL

This is a package of 1 vial of Phentolamine Mesylate 5 mg/mL Injection, Powder, For Solution from Hikma Pharmaceuticals USA Inc., marketed since May 1998 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00143-9564-01
🏷️ FDA NDC (as labeled) 0143-9564-01 billing pads the labeler segment with a zero
This package
Contains1 vial Pack sizes2 compare ↓
Main listing for product 0143-9564 · Also comes in: 10 vials 0143-9564-10
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 Phentolamine Mesylate (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 · Oct 31, 2025 — Defective container: cracked/broken cartridges (Novocol Pharmaceutical of Canada, Inc.) · FDA recall D-0234-2026
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) 0143-9564-01
Product NDC 0143-9564
11-digit billing NDC 00143956401
NCPDP billing unit EA — each (per item)
RxCUI 1361023
UNII Y7543E5K9T
Application # ANDA040235
SPL Set ID ed6c506c-5535-4b7c-ae1a-d63f09d796c9
Established class (EPC) alpha-Adrenergic Blocker
Mechanism of action Adrenergic alpha-Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1998-05-15
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, POWDER, FOR SOLUTION
Substance PHENTOLAMINE MESYLATE
TE code (Orange Book) AP · RLD · RS

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

GPI-14 36300020102105
GPI class Phentolamine Mesylate
GCN Seq No 005112
GCN 20610
HICL code 002100
Ingredient (HICL) Phentolamine Mesylate
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J7
Therapeutic class — intermediate (HIC2) Antiadrenergics
HIC3 code J7B
Therapeutic class — specific (HIC3) Alpha-Adrenergic Blocking Agents
AHFS code 12:16.04.04
AHFS class Non-Sel.alpha-Adrenergic Blocking Agents
FDB label name PHENTOLAMINE 5 MG VIAL
FDB brand name Phentolamine Mesylate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 005112
  • GCN: 20610
  • GPI-14 (Medi-Span): 36300020102105
  • HICL (First Databank): 002100
  • AHFS class code: 12:16.04.04
  • RxCUI (RxNorm): 1361023
Why two NDCs? The FDA registers this code as 0143-9564-01 — a 4-4-2 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 labeler segment → 00143-9564-01. 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.

RxNorm drug class

This medicine belongs to the alpha-Adrenergic Blocker class.

Pharmacologic class alpha-Adrenergic Blocker
Drug family (ATC) Imidazoline derivatives, Antidotes
How it works Adrenergic alpha-Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name PHENTOLAMINE 5 MG VIAL Ingredient Phentolamine Mesylate

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 · J2760 $288.625 / J2760 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)0143-9564-01
11-digit billing NDC00143-9564-01
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ2760
DescriptorInjection, phentolamine mesylate, up to 5 mg
Billing units / pkg1 units
How the units are derivedThis package is 1; the HCPCS unit is 5 MG, so one package = 1 billing unit.
Medicare Part B spend (2026 (Q1))$39,292 · 175 claims · $224.52 per claim (all NDCs under J2760)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
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
00143-9564-01 You're viewing this Main listing 1 VIAL in 1 BOX / 1 mL in 1 VIAL 2015-11-04 — Active
00143-9564-10 0143-9564-10 10 VIAL in 1 BOX / 1 mL in 1 VIAL 2015-11-04 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1 vial — 1 vial in 1 box / 1 ml in 1 vial.
How does this package differ from NDC 00143-9564-10?
Both are Phentolamine Mesylate 5 mg/mL Injection, Powder, For Solution — the drug itself is identical. This page's package is the 1 vial one, while NDC 00143-9564-10 is the 10 vials package.
What NDC number is used to bill for this package of Phentolamine Mesylate 5 mg/mL Injection, Powder, For Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Phentolamine Mesylate 5 mg/mLthis 00143-9564-01 Hikma 1 vial — AP FDA listed —
Phentolamine Mesylate 5 mg 68094-0101-10 Precision 1 vial — AP Discontinued —
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

🏛️
1998
On the market since
May 1998
📍
2026
Currently FDA-listed
28 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

LabelerHikma Pharmaceuticals USA Inc.
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationANDA040235 (ANDA)
Labeler code00143
First marketedMay 1998
Product typeHuman Prescription Drug
Portfolio726 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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 78 words ▾

INDICATIONS AND USAGE Phentolamine Mesylate for Injection is indicated for the prevention or control of hypertensive episodes that may occur in a patient with pheochromocytoma as a result of stress or manipulation during preoperative preparation and surgical excision. Phentolamine Mesylate for Injection is indicated for the prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine. Phentolamine Mesylate for Injection is also indicated for the diagnosis of pheochromocytoma by the phentolamine blocking test.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION The reconstituted solution should be used upon preparation and should not be stored. 1. Prevention or control of hypertensive episodes in the patient with pheochromo-cytoma.

For preoperative reduction of elevated blood pressure, 5 mg of phentolamine mesylate (1 mg for children) is injected intravenously or intramuscularly 1 or 2 hours before surgery, and repeated if necessary. During surgery, phentolamine mesylate (5 mg for adults, 1 mg for children) is administered intravenously as indicated, to help prevent or control paroxysms of hypertension, tachycardia, respiratory depression, convulsions, or other effects of epinephrine intoxication. (Postoperatively, norepinephrine may be given to control the hypotension that commonly follows complete removal of a pheochromocytoma.) 2.

Prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine. For Prevention: 10 mg of phentolamine mesylate is added to each liter of solution containing norepinephrine. The pressor effect of norepinephrine is not affected.

For Treatment: 5 to 10 mg of phentolamine mesylate in 10 mL of saline is injected into the area of extravasation within 12 hours. 3. Diagnosis of pheochromocytoma - phentolamine blocking test .

The test is most reliable in detecting pheochromocytoma in patients with sustained hypertension and least reliable in those with paroxysmal hypertension. False-positive tests may occur in patients with hypertension without pheochromocytoma. a. Intravenous Preparation The CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS sections should be reviewed.

Sedatives, analgesics, and all other medications except those that might be deemed essential (such as digitalis and insulin) are withheld for at least 24 hours, and preferably 48 to 72 hours, prior to the test. Antihypertensive drugs are withheld until blood pressure returns to the untreated, hypertensive level. This test is not preformed on a patient who is normotensive.

Procedure The patient is kept at rest in a supine position throughout the test, preferably in a quiet, darkened room. Injection of phentolamine is delayed until blood pressure is stabilized, as evidenced by blood pressure readings taken every 10 minutes for at least 30 minutes. Five milligrams of phentolamine mesylate is dissolved in 1 mL of Sterile Water for Injection.

The dose for adults is 5 mg; for children, 1 mg. The syringe needle is inserted into the vein, and injection is delayed until pressor response to venipuncture has subsided. Phentolamine is injected rapidly.

Blood pressure is recorded immediately after injection, at 30-second intervals for the first 3 minutes, and at 60-second intervals for the next 7 minutes. Interpretation A positive response, suggestive of pheochromocytoma, is indicated when the blood pressure is reduced more than 35 mm Hg systolic and 25 mm Hg diastolic. A typical positive response is a reduction in pressure of 60 mm Hg systolic and 25 mm Hg diastolic.

Usually, maximal effect is evident within 2 minutes after injection. A return to preinjection pressure commonly occurs within 15 to 30 minutes but may occur more rapidly. If blood pressure decreases to a dangerous level, the patient should be treated as outlined under OVERDOSAGE .

A positive response should always be confirmed by other diagnostic procedures, preferably by measurement of urinary catecholamines or their metabolites. A negative response is indicated when the blood pressure is elevated, unchanged, or reduced less than 35 mm Hg systolic and 25 mm Hg diastolic after injection of phentolamine. A negative response to this test does not exclude the diagnosis of pheo-chromocytoma, especially in patients with paroxysmal hypertension in whom the incidence of false-negative responses is high. b.

Intramuscular If the intramuscular test for pheochromocytoma is preferred, preparation is the same as for the intravenous test. Five milligrams of phentolamine me… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 24 words ▾

CONTRAINDICATIONS Myocardial infarction, history of myocardial infarction, coronary insufficiency, angina, or other evidence suggestive of coronary artery disease; hypersensitivity to phentolamine or related compounds.

⚠️ Warnings 107 words ▾

WARNINGS Myocardial infarction, cerebrovascular spasm, and cerebrovascular occlusion have been reported to occur following the administration of phentolamine, usually in association with marked hypotensive episodes. For screening tests in patients with hypertension, the generally available urinary assay of catecholamines or other biochemical assays have largely replaced the phentolamine and other pharmacological tests for reasons of accuracy and safety. None of the chemical or pharmacological tests is infallible in the diagnosis of pheochromocytoma.

The phentolamine blocking test is not the procedure of choice and should be reserved for cases in which additional confirmatory evidence is necessary and the relative risks involved in conducting the test have been considered.

🤒 Adverse Reactions 29 words ▾

ADVERSE REACTIONS Acute and prolonged hypotensive episodes, tachycardia, and cardiac arrhythmias have been reported. In addition, weakness, dizziness, flushing, orthostatic hypotension, nasal stuffiness, nausea, vomiting, and diarrhea may occur.

🔄 Drug Interactions 13 words ▾

Drug Interactions See DOSAGE AND ADMINISTRATION . Diagnosis of pheochromocytoma , Preparation .

🤰 Pregnancy 162 words ▾

Pregnancy Teratogenic Effects-Pregnancy Category C Administration of phentolamine to pregnant rats and mice at oral doses 24 to 30 times the usual daily human dose (based on a 60 kg human) resulted in slightly decreased growth and slight skeletal immaturity of the fetuses. Immaturity was manifested by increased incidence of incomplete or unossified calcanei and phalangeal nuclei of the hind limb and of incompletely ossified sternebrae. At oral doses 60 times the usual daily human dose (based on a 60 kg human), a slightly lower rate of implantation was found in the rat.

Phentolamine did not affect embryonic or fetal development in the rabbit at oral doses 20 times the usual daily human dose (based on a 60 kg human). No teratogenic or embryotoxic effects were observed in the rat, mouse, or rabbit studies. There are no adequate and well-controlled studies in pregnant women.

Phentolamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 7 words ▾

Pediatric Use See DOSAGE AND ADMINISTRATION .

🆘 Overdosage 138 words ▾

OVERDOSAGE Acute Toxicity No deaths due to acute poisoning with phentolamine have been reported. Oral LD 50 ’s (mg/kg): mice, 1000; rats, 1250. Signs and Symptoms Overdosage with phentolamine is characterized chiefly by cardiovascular disturbances, such as arrhythmias, tachycardia, hypotension, and possibly shock.

In addition, the following might occur: excitation, headache, sweating, pupillary contraction, visual disturbances; nausea, vomiting, diarrhea; hypoglycemia. Treatment There is no specific antidote. A decrease in blood pressure to dangerous levels or other evidence of shocklike conditions should be treated vigorously and promptly.

The patient’s legs should be kept raised and a plasma expander should be administered. If necessary, intravenous infusion or norepi-nephrine, titrated to maintain blood pressure at the normotensive level, and all available supportive measures should be included. Epinephrine should not be used, since it may cause a paradoxical reduction in blood pressure.

🧬 Clinical Pharmacology 61 words ▾

CLINICAL PHARMACOLOGY Phentolamine mesylate produces an alpha-adrenergic block of relatively short duration. It also has direct, but less marked, positive inotropic and chronotropic effects on cardiac muscle and vasodilator effects on vascular smooth muscle. Phentolamine has a half-life in the blood of 19 minutes following intravenous administration. Approximately 13% of a single intravenous dose appears in the urine as unchanged drug.

📦 How Supplied / Storage and Handling 127 words ▾

HOW SUPPLIED Phentolamine Mesylate for Injection, USP, 5 mg, for intramuscular or intravenous use, is supplied as follows: NDC 0143-9564-01 - 2 mL vials packaged individually. NDC 0143-9564-10 - 2 mL vials packaged in cartons of 10 vials. The reconstituted solution should be used upon preparation and should not be stored.

Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689.

Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised May 2022 PIN385-WES/5

📋 Description 103 words ▾

DESCRIPTION Phentolamine Mesylate for Injection, USP, is an antihypertensive, available in vials for intravenous and intramuscular administration. Each vial contains phentolamine mesylate USP, 5 mg and mannitol USP, 25 mg in sterile, lyophilized form. Phentolamine mesylate is m -[ N -(2-Imidazolin-2-ylmethyl)- p -toluidino]phenol monomethanesulfonate (salt), and its structural formula is: Molecular Formula C 17 H 19 N 3 O•CH 4 O 3 S M.W.

377.47 Phentolamine mesylate, USP is a white or off-white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in alcohol, and slightly soluble in chloroform.

It melts at about 178°C. structural formula

⚠️ Precautions ~1 min read ▾

PRECAUTIONS General Tachycardia and cardiac arrhythmias may occur with the use of phentolamine or other alpha-adrenergic blocking agents. When possible, administration of cardiac glycosides should be deferred until cardiac rhythm returns to normal. Drug Interactions See DOSAGE AND ADMINISTRATION .

Diagnosis of pheochromocytoma , Preparation . Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies, mutagenicity studies, and fertility studies have not been conducted with phentolamine. Pregnancy Teratogenic Effects-Pregnancy Category C Administration of phentolamine to pregnant rats and mice at oral doses 24 to 30 times the usual daily human dose (based on a 60 kg human) resulted in slightly decreased growth and slight skeletal immaturity of the fetuses.

Immaturity was manifested by increased incidence of incomplete or unossified calcanei and phalangeal nuclei of the hind limb and of incompletely ossified sternebrae. At oral doses 60 times the usual daily human dose (based on a 60 kg human), a slightly lower rate of implantation was found in the rat. Phentolamine did not affect embryonic or fetal development in the rabbit at oral doses 20 times the usual daily human dose (based on a 60 kg human).

No teratogenic or embryotoxic effects were observed in the rat, mouse, or rabbit studies. There are no adequate and well-controlled studies in pregnant women. Phentolamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from phentolamine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use See DOSAGE AND ADMINISTRATION .

🍼 Nursing Mothers 61 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from phentolamine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 19 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies, mutagenicity studies, and fertility studies have not been conducted with phentolamine.

📄 Package Label / Principal Display Panel 107 words ▾

PACKAGE LABEL PRINCIPAL DISPLAY PANEL NDC 0143- 9564 -01 Rx only Phentolamine Mesylate for Injection, USP 5 mg per vial For IM or IV Use LYOPHILIZED 5 mg vial

PACKAGE LABEL PRINCIPAL DISPLAY PANEL NDC 0143- 9564 -01 Rx only Phentolamine Mesylate for Injection, USP 5 mg per vial For IM or IV Use LYOPHILIZED 1 x 2 mL Vial 5 mg carton

PACKAGE LABEL PRINCIPAL DISPLAY PANEL NDC 0143- 9564 -10 Rx only Phentolamine Mesylate for Injection, USP 5 mg/vial For IM or IV Use LYOPHILIZED 10 x 2 mL Vials 10 x 2mL 5mg carton

SERIALIZATION IMAGE Representative Carton Serialization Image Representative Carton Serialization Image

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for PHENTOLAMINE MESYLATE — the ingredient across all brands.

Top reported reactions

Ocular Hyperaemia20
Blood Urea Increased14
Blood Glucose Increased13
Headache13
Neutrophil Count Increased13
Anaemia12
Diarrhoea12

Age at onset

Child1
Adult14
Elderly2

Reporter sex

158 reports
Male · 49%
Female · 51%

Serious outcomes

Hospitalization44
Death11
Life-threatening7
Disabling2
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 27 3
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 Hikma Pharmaceuticals USA Inc.. 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 1 other package presentation of this same product, including 10 vials (00143-9564-10). 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?
Hikma Pharmaceuticals USA Inc. 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 J2760 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.
← 00143-9559-01 · Hikma 00143-9565-01 · Hikma →
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.