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DOBUTAMINE 200 mg/100mL Injection, Solution, 250 mL — NDC 51662-1330-1 (Billing 51662-1330-01)

by HF Acquisition Co LLC, DBA HealthFirst · 250 mL in 1 BAG

This is a package of 250 mL of DOBUTAMINE 200 mg/100mL Injection, Solution from HF Acquisition Co LLC, DBA HealthFirst, no longer marketed (first marketed Apr 2019), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 51662-1330-01
🏷️ FDA NDC (as labeled) 51662-1330-1 billing pads the package segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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 Dobutamine (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 · May 28, 2025 — Discoloration; discolored solution from cracked vials (Pfizer Inc.) · FDA recall D-0489-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Sep 2025. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51662-1330-1
Product NDC 51662-1330
11-digit billing NDC 51662133001
RxCUI 309986
UNII 0WR771DJXV
Application # NDA020201
SPL Set ID 85fb5ba6-3597-e09f-e053-2a91aa0aded5
Established class (EPC) beta-Adrenergic Agonist
Mechanism of action Adrenergic beta-Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Sep 2025)
Marketing start 2019-04-07
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DOBUTAMINE HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS
Quick answers
  • RxCUI (RxNorm): 309986
Why two NDCs? The FDA registers this code as 51662-1330-1 — a 5-4-1 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 package segment → 51662-1330-01. 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 beta-Adrenergic Agonist class.

Pharmacologic class beta-Adrenergic Agonist
Drug family (ATC) Adrenergic and dopaminergic agents
How it works Adrenergic beta-Agonists
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

📗 Our plain-language guide HelloPharmacist
  • It gives short-term support to a weak heart. It is used when the heart cannot pump well because of organic heart disease or after heart surgery. It is not for long-term heart failu...
  • It is given through an IV by your care team. They start at a low rate and adjust it every few minutes while watching your blood pressure, heart rate and urine output. You do not ta...
  • A faster heartbeat and higher blood pressure are common. Some people have extra heartbeats, nausea, headache, chest pain or shortness of breath. Tell your nurse if you feel any of...
  • Say something if you have chest pain, a racing heartbeat, trouble breathing, dizziness, rash, wheezing, or pain or swelling at the IV site. The dose can often be lowered if there i...
📖 Read our full Dobutamine guide →
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 · J1250 $7.691 / J1250 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)51662-1330-1
11-digit billing NDC51662-1330-01
Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)
HCPCS J-codeJ1250
DescriptorInjection, dobutamine hydrochloride, per 250 mg
Billing units / pkg2 units
Medicare Part B spend (2026 (Q1))$183,526 · 2,155 claims · $85.16 per claim (all NDCs under J1250)
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
51662-1330-01 You're viewing this Main listing 250 mL in 1 BAG 2019-04-07 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dobutamine Hydrochloride in Dextrose 200 mg/100mL 00338-1075-02 Baxter 250 ml — AP FDA listed —
Dobutamine in Dextrose 200 mg/100mL 00409-0151-10 Hospira, 12 pouches — AP FDA listed —
Dobutamine 200 mg/100mLthis 51662-1330-01 HF 250 ml — AP Discontinued —
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

🏛️
2019
On the market since
Apr 2019
📍
2026
Currently FDA-listed
7 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒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.

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

LabelerHF Acquisition Co LLC, DBA HealthFirst
Application holderHOSPIRA INC
FDA applicationNDA020201 (NDA)
Labeler code51662
First marketedApr 2019
Product typeHuman Prescription Drug
Portfolio333 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 138 words ▾

INDICATIONS & USAGE Dobutamine in 5% Dextrose Injection, USP is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure.

In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE & ADMINISTRATION Recommended Dosage Dobutamine in 5% Dextrose Injection, USP is administered intravenously through a suitable intravenous catheter or needle. A calibrated electronic infusion device is recommended for controlling the rate of flow in mL/hour or drops/minute. Infusion of dobutamine should be started at a low rate (0.5 to 1.0 µg/kg/min) and titrated at intervals of a few minutes, guided by the patient's response, including systemic blood pressure, urine flow, frequency of ectopic activity, heart rate, and (whenever possible) measurements of cardiac output, central venous pressure, and/or pulmonary capillary wedge pressure.

In reported trials, the optimal infusion rates have varied from patient to patient, usually 2 to 20 µg/kg/min but sometimes slightly outside of this range. On rare occasions, infusion rates up to 40 µg/kg/min have been required to obtain the desired effect. Rates of infusion in mL/hour for dobutamine hydrochloride concentrations of 500, 1,000, 2,000 and 4,000 mg/L may be calculated using the following formula: Infusion Rate (mL/h) = [Dose (µg/kg/min) x Weight (kg) x 60 min/h] Final Concentration (µg/mL) Example calculations for infusion rates are as follows: Example 1: for a 60 kg person at an initial dose of 0.5 µg/kg/min using a 500 µg/mL concentration, the infusion rate would be as follows: Infusion Rate (mL/h) = [0.5 (µg/kg/min) x 60 (kg) x 60 (min/h)] = 3.6 (mL/h) 500 (µg/mL) Example 2: for a 80 kg person at a dose of 10 µg/kg/min using a 2,000 µg/mL concentration, the infusion rate would be as follows: Infusion Rate (mL/h) = [10 (µg/kg/min) x 80 (kg) x 60 (min/h)] = 24 (mL/h) 2,000 (µg/mL) This container system may be inappropriate for the dosage requirements of pediatric patients under 30 kg.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Dobutamine in 5% Dextrose Injection, USP solutions may exhibit a pink color that, if present, will increase with time. This color change is due to slight oxidation of the drug, but there is no significant loss of potency.

Solutions containing dextrose should not be administered through the same administration set as blood, as this may result in pseudoagglutination or hemolysis. Do not add supplementary medications to Dobutamine in 5% Dextrose Injection, USP. Do not administer Dobutamine in 5% Dextrose Injection, USP simultaneously with solutions containing sodium bicarbonate or strong alkaline solutions.

INSTRUCTIONS FOR USE To Open Tear outer wrap at notch and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety.

The opacity will diminish gradually. Preparation for Administration (Use aseptic technique) 1. Close flow control clamp of administration set.

2. Remove cover from outlet port at bottom of container. 3.

Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: See full directions on administration set carton. 4.

Suspend container from hanger. 5. Squeeze and release drip chamber to establish proper fluid level in chamber.

6. Open flow control clamp and clear air from set. Close clamp.

7. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.

8. Regulate rate of administration with flow control clamp. WARNING: Do not use flexible container in series connections.

⛔ Contraindications 33 words ▾

CONTRAINDICATIONS Dobutamine in 5% Dextrose Injection, USP is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to dobutamine or any of its components.

⚠️ Warnings 218 words ▾

WARNINGS Increase in Heart Rate or Blood Pressure Dobutamine hydrochloride may cause a marked increase in heart rate or blood pressure, especially systolic pressure. Approximately 10% of adult patients in clinical studies have had rate increases of 30 beats/minute or more, and about 7.5% have had a 50-mm Hg or greater increase in systolic pressure. Usually, reduction of dosage reverses these effects.

Because dobutamine facilitates atrioventricular conduction, patients with atrial fibrillation are at risk of developing rapid ventricular response. In patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with dobutamine. Patients with pre-existing hypertension appear to face an increased risk of developing an exaggerated pressure response.

Ectopic Activity Dobutamine may precipitate or exacerbate ventricular ectopic activity, but it rarely has caused ventricular tachycardia. Hypersensitivity Reactions suggestive of hypersensitivity associated with administration of Dobutamine in 5% Dextrose Injection, USP, including skin rash, fever, eosinophilia, and bronchospasm, have been reported occasionally. Dobutamine in 5% Dextrose Injection, USP contains sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes, in certain susceptible people.

The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

🤒 Adverse Reactions 182 words ▾

ADVERSE REACTIONS Increased Heart Rate, Blood Pressure, and Ventricular Ectopic Activity: A 10- to 20-mm Hg increase in systolic blood pressure and an increase in heart rate of 5 to 15 beats/minute have been noted in most patients (see WARNINGS regarding exaggerated chronotropic and pressor effects). Approximately 5% of adult patients have had increased premature ventricular beats during infusions. These effects are dose related.

Hypotension: Precipitous decreases in blood pressure have occasionally been described in association with dobutamine therapy. Decreasing the dose or discontinuing the infusion typically results in rapid return of blood pressure to baseline values. In rare cases, however, intervention may be required and reversibility may not be immediate.

Reactions at Sites of Intravenous Infusion: Phlebitis has occasionally been reported. Local inflammatory changes have been described following inadvertent infiltration. Miscellaneous Uncommon Effects: The following adverse effects have been reported in 1% to 3% of adult patients: nausea, headache, anginal pain, nonspecific chest pain, palpitations, and shortness of breath.

Administration of dobutamine, like other catecholamines, has been associated with decreases in serum potassium concentrations, rarely to hypokalemic values (See PRECAUTIONS ).

🆘 Overdosage ~2 min read ▾

OVERDOSAGE Overdoses of dobutamine have been reported rarely. The following is provided to serve as a guide if such an overdose is encountered. Signs and Symptoms: Toxicity from dobutamine hydrochloride is usually due to excessive cardiac β-receptor stimulation.

The duration of action of dobutamine hydrochloride is generally short (T½ = 2 minutes) because it is rapidly metabolized by catechol-O-methyltransferase. The symptoms of toxicity may include anorexia, nausea, vomiting, tremor, anxiety, palpitations, headache, shortness of breath, and anginal and nonspecific chest pain. The positive inotropic and chronotropic effects of dobutamine on the myocardium may cause hypertension, tachyarrhythmias, myocardial ischemia, and ventricular fibrillation.

Hypotension may result from vasodilation. If the product is ingested, unpredictable absorption may occur from the mouth and the gastrointestinal tract. Treatment: To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center.

Telephone numbers of certified poison control centers are listed in the Physicians' Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient. The initial actions to be taken in a dobutamine hydrochloride overdose are discontinuing administration, establishing an airway, and ensuring oxygenation and ventilation.

Resuscitative measures should be initiated promptly. Severe ventricular tachyarrhythmias may be successfully treated with propranolol or lidocaine. Hypertension usually responds to a reduction in dose or discontinuation of therapy.

Protect the patient's airway and support ventilation and perfusion. If needed, meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying.

Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal. Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of dobutamine hydrochloride.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICALPHARMACOLOGY Dobutamine is a direct-acting inotropic agent whose primary activity results from stimulation of the β-receptors of the heart while producing comparatively mild chronotropic, hypertensive, arrhythmogenic, and vasodilative effects. It does not cause the release of endogenous norepinephrine, as does dopamine. In animal studies, dobutamine produces less increase in heart rate and less decrease in peripheral vascular resistance for a given inotropic effect than does isoproterenol.

In patients with depressed cardiac function, both dobutamine and isoproterenol increase the cardiac output to a similar degree. In the case of dobutamine, this increase is usually not accompanied by marked increases in heart rate (although tachycardia is occasionally observed), and the cardiac stroke volume is usually increased. In contrast, isoproterenol increases the cardiac index primarily by increasing the heart rate while stroke volume changes little or declines.

Facilitation of atrioventricular conduction has been observed in human electrophysiologic studies and in patients with atrial fibrillation. Systemic vascular resistance is usually decreased with administration of dobutamine. Occasionally, minimum vasoconstriction has been observed.

Most clinical experience with dobutamine is short-term, not more than several hours in duration. In the limited number of patients who were studied for 24, 48, and 72 hours, a persistent increase in cardiac output occurred in some, whereas output returned toward baseline values in others. The onset of action of Dobutamine in 5% Dextrose Injection, USP is within 1 to 2 minutes; however, as much as 10 minutes may be required to obtain the peak effect of a particular infusion rate.

The plasma half-life of dobutamine in humans is 2 minutes. The principal routes of metabolism are methylation of the catechol and conjugation. In human urine, the major excretion products are the conjugates of dobutamine and 3-O-methyl dobutamine.

The 3-O-methyl derivative of dobutamine is inactive. Alteration of synaptic concentrations of catecholamines with either reserpine or tricyclic antidepressants does not alter the actions of dobutamine in animals, which indicates that the actions of dobutamine are not dependent on presynaptic mechanisms. The effective infusion rate of dobutamine varies widely from patient to patient, and titration is always necessary (see DOSAGE & ADMINISTRATION ).

At least in pediatric patients, dobutamine-induced increases in cardiac output and systemic pressure are generally seen, in any given patient, at lower infusion rates than those that cause substantial tachycardia (See Pediatric Use under PRECAUTIONS ).

📦 How Supplied / Storage and Handling 92 words ▾

HOW SUPPLIED DOBUTAMINE IN 5% DEXTROSE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1330-1 DOBUTAMINE IN 5% DEXTROSE INJECTION, USP 500mg 250mL BAG HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms DOBUTamine in 5% Dextrose Injection, USP is supplied in 250 and 500 mL LifeCare™ flexible containers as follows: Do not freeze. Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1181-1.0 Revised: 04/2018 HOW SUPPLIED

📋 Description ~1 min read ▾

DESCRIPTION Dobutamine in 5% Dextrose Injection, USP is a sterile, nonpyrogenic, prediluted solution of dobutamine hydrochloride and dextrose in water for injection. It is administered by intravenous infusion. Each 100 mL contains dobutamine hydrochloride equivalent to 100 mg, 200 mg, or 400 mg of dobutamine; dextrose (derived from corn), hydrous 5 g in water for injection, with sodium metabisulfite 25 mg and edetate disodium, dihydrate 10 mg added as stabilizers; osmolar concentration, respectively, 263, 270, or 284 mOsmol/liter (calc.).

The pH is 3.0 (2.5 to 5.5). May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Dobutamine in 5% Dextrose Injection, USP is oxygen sensitive.

Dobutamine Hydrochloride, USP is chemically designated (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 • H2O), a hexose sugar freely soluble in water.

It has the following structural formula: Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated CR3 plastic material. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.

Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses.

It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. STRUCTURE 1 STRUCTURE 2

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

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
HF Acquisition Co LLC, DBA HealthFirst 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 J1250 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.
← 51662-1329-01 · HF 51662-1332-01 · HF →
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.