NDC 63323-665-01 (63323-0665-01) — Terbutaline Sulfate 1 mg/mL, 25 vials

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63323-665-01

Product NDC 63323-665

11-digit billing NDC 63323066501

NCPDP billing unit ML — per mL (volume)

RxCUI 857635

UNII 576PU70Y8E

UPC 0363323665005

Application # ANDA076887

SPL Set ID cec31032-f366-4524-9e01-63146e473b2b

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2011-03-10

Route SUBCUTANEOUS

Dosage form INJECTION, SOLUTION

Substance TERBUTALINE SULFATE

TE code (Orange Book) AP · RLD · RS

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

GPI-14 44201060202005

GPI class Terbutaline Sulfate

GCN Seq No 054007

GCN 21815

HICL code 002071

Ingredient (HICL) Terbutaline Sulfate

HIC1 code J

Therapeutic class — broad (HIC1) Autonomic Nervous System

HIC2 code J5

Therapeutic class — intermediate (HIC2) Adrenergics

HIC3 code J5D

Therapeutic class — specific (HIC3) Beta-Adrenergic Agents

AHFS code 12:12.08.12

AHFS class Selective Beta-2-Adrenergic Agonists

FDB label name TERBUTALINE SULF 1 MG/ML VIAL

FDB brand name Terbutaline Sulfate

Legend status F — Federal legend — prescription drug or device

Quick answers

GSN (GCN sequence number): 054007
GCN: 21815
GPI-14 (Medi-Span): 44201060202005
HICL (First Databank): 002071
AHFS class code: 12:12.08.12
RxCUI (RxNorm): 857635

Why two NDCs? The FDA registers this code as 63323-665-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63323-0665-01. 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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 5, 2026
RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
Medi-Span GPI (licensed)
First Databank (licensed) · refreshed Oct 1, 2026

RxNorm drug class

This medicine belongs to the Selective beta-2-adrenoreceptor agonists class.

Drug family (ATC) Selective beta-2-adrenoreceptor agonists, Selective beta-2-adrenoreceptor 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.

RxClass (NLM) · catalog refreshed Oct 1, 2026

Clinical

Label name TERBUTALINE SULF 1 MG/ML VIAL Ingredient Terbutaline Sulfate

📖 What it is MedlinePlus · NLM

Terbutaline injection is used to treat wheezing, shortness of breath, coughing, and chest tightness caused by asthma, chronic bronchitis, and emphysema. Terbutaline is in a class of medications called beta agonists. It works by relaxing and opening the airways, making it easier to breathe.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

It helps open tight airways. It is used to prevent and reverse bronchospasm in people 12 and older with asthma, or with bronchitis and emphysema.
It is injected under the skin, usually in the upper arm. You may notice a change in airflow within about 5 minutes, with a clear improvement by about 15 minutes. The effect usually...
How is it given and how fast does it work?
Shakiness, nervousness, a pounding heartbeat, headache, dizziness and drowsiness are common. They are usually brief. Call for help if you have chest pain, a very fast or irregular...

📖 Read our full Terbutaline Injection guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

2

Nutrient depletion considerations

Terbutaline may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

MAGNESIUM Insignificant Depletion POTASSIUM Moderate Depletion

🧪 Full Terbutaline nutrient depletion report →

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.

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.

MedlinePlus (NLM) · refreshed Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 5, 2026

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	$31.36	$783.89 / 25 ml
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J3105	$2.820 / J3105 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.

CMS NADAC weekly file
CMS ASP pricing files · refreshed Sep 20, 2026
CMS Medicaid State Drug Utilization Data · through Q1 2026
CMS Part D plan pricing files · refreshed Sep 24, 2026
VA National Acquisition Center price file

Billing & reimbursement

FDA NDC (as labeled)63323-665-01

11-digit billing NDC63323-0665-01

Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)

HCPCS J-codeJ3105

DescriptorINJECTION, TERBUTALINE SULFATE, UP TO 1 MG

Billing units / pkg1 units

How the units are derivedThis package is 1 ML; the HCPCS unit is 1 MG, so one package = 1 billing unit.

Medicare Part B spend (2025 (Q1-Q4))$88 · 30 claims · $2.92 per claim (all NDCs under J3105)

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.

CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
DMEPDAC NDC-HCPCS crosswalk
openFDA NSDE billing units · refreshed Sep 7, 2026

Packaging — all sizes for this product

Package NDC	Description	Marketing start	Marketing end	Status
63323-0665-01 You're viewing this Main listing	25 VIAL, SINGLE-USE in 1 TRAY / 1 mL in 1 VIAL, SINGLE-USE	2011-03-10	—	Active

Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Terbutaline Sulfate 1 mg/mL 00143-9375-10	Hikma	10 vials	—	AP	FDA listed	—
Terbutaline Sulfate 1 mg/mL 00143-9746-10	Hikma	10 vials	—	AP	FDA listed	—
Terbutaline Sulfate 1 mg/mL 00404-9962-01	Henry	1 vial	—	AP	FDA listed	—
Terbutaline Sulfate 1 mg/mLthis 63323-0665-01	Fresenius	25 vials	—	AP	FDA listed	—
Terbutaline Sulfate 1 mg/mL 71872-7080-01	Medical	1 vial	—	AP	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA Orange Book · refreshed Oct 3, 2026
CMS NADAC weekly file

Availability & generic status

🏛️

2011

On the market since

Mar 2011

📍

2026

Currently FDA-listed

15 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.

FDA Orange Book · refreshed Oct 3, 2026

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.

🧪 Avoiding an ingredient? See Terbutaline Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
8.9 mg / 1 mL UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

FDA label on DailyMed · label index refreshed Oct 5, 2026
FDA openFDA NDC Directory · synced Oct 1, 2026

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerFresenius Kabi USA, LLC

Application holderFRESENIUS KABI USA LLC

FDA applicationANDA076887 (ANDA)

Labeler code63323

First marketedMar 2011

Product typeHuman Prescription Drug

Portfolio554 products on file

More NDCs from Fresenius Kabi USA, LLC labeler code 63323

🔎 All NDCs from Fresenius Kabi USA, LLC

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.

FDA openFDA NDC Directory · synced Oct 1, 2026
Drugs@FDA

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.

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel

🚨 Boxed Warning 96 words ▾

WARNING: PROLONGED TOCOLYSIS Terbutaline sulfate has not been approved and should not be used for prolonged tocolysis (beyond 48 to 72 hours). In particular, terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting. Serious adverse reactions, including death, have been reported after administration of terbutaline sulfate to pregnant women.

In the mother, these adverse reactions include increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema and myocardial ischemia. Increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration (see CONTRAINDICATIONS , Prolonged Tocolysis ).

🎯 Indications and Usage 34 words ▾

INDICATIONS AND USAGE Terbutaline Sulfate Injection, USP is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.

⏱️ Dosage and Administration 135 words ▾

DOSAGE AND ADMINISTRATION Terbutaline Sulfate Injection, USP should be used only for subcutaneous administration and not intravenous infusion. Sterility and accurate dosing cannot be assured if the vials are not used in accordance with DOSAGE AND ADMINISTRATION . Discard unused portion after single patient use.

The usual subcutaneous dose of Terbutaline Sulfate Injection, USP is 0.25 mg injected into the lateral deltoid area. If significant clinical improvement does not occur within 15 to 30 minutes, a second dose of 0.25 mg may be administered. If the patient then fails to respond within another 15 to 30 minutes, other therapeutic measures should be considered.

The total dose within 4 hours should not exceed 0.5 mg. Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

⛔ Contraindications 135 words ▾

CONTRAINDICATIONS Prolonged Tocolysis Terbutaline sulfate has not been approved and should not be used for prolonged tocolysis (beyond 48 to 72 hours). In particular, terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting (see BOXED WARNING : PROLONGED TOCOLYSIS ). Hypersensitivity Terbutaline sulfate injection is contraindicated in patients known to be hypersensitive to sympathomimetic amines or any component of this drug product.

Prolonged Tocolysis Terbutaline sulfate has not been approved and should not be used for prolonged tocolysis (beyond 48 to 72 hours). In particular, terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting (see BOXED WARNING : PROLONGED TOCOLYSIS ).

Hypersensitivity Terbutaline sulfate injection is contraindicated in patients known to be hypersensitive to sympathomimetic amines or any component of this drug product.

⚠️ Warnings ~2 min read ▾

WARNINGS Deterioration of Asthma Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of terbutaline than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids. Use of Anti-Inflammatory Agents The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients.

Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids. Cardiovascular Effects Terbutaline, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of terbutaline at recommended doses, if they occur, the drug may need to be discontinued.

In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, terbutaline, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Seizures There have been rare reports of seizures in patients receiving terbutaline; seizures did not recur in these patients after the drug was discontinued.

Deterioration of Asthma Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of terbutaline than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

Use of Anti-Inflammatory Agents The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids.

Cardiovascular Effects Terbutaline, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of terbutaline at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression.

The clinical significance of these findings is unknown. Therefore, terbutaline, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Seizures There have been rare reports of seizures in patients receiving terbutaline; seizures did not recur in these patients after the drug was discontinued.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Adverse reactions observed with terbutaline are similar to those commonly seen with other sympathomimetic agents. All these reactions are transient in nature and usually do not require treatment.

The following table compares adverse reactions seen in patients treated with terbutaline (0.25 mg and 0.5 mg), with those seen in patients treated with epinephrine injection (0.25 mg and 0.5 mg), during eight double-blind crossover studies involving a total of 214 patients. Incidence (%) of Adverse Reactions Terbutaline (%) 0.25 mg N=77 0.5 mg N=205 Reaction Central Nervous System Tremor 7.8 38 Nervousness 16.9

30.7Dizziness 1.3

10.2Headache 7.8

8.8Drowsiness 11.7

9.8Cardiovascular Palpitations 7.8

22.9Tachycardia 1.3

1.5Respiratory Dyspnea 0 2 Chest discomfort 1.3

1.5Gastrointestinal Nausea/vomiting 1.3

3.9Systemic Weakness 1.3

0.5 Flushed feeling 0

2.4 Sweating 0

2.5Pain at injection site 2.6

0.5Epinephrine (%) 0.25 mg N=153 0.5 mg N=61 Reaction Central Nervous System Tremor 16.3 18 Nervousness 8.5

31.1Dizziness 7.8

3.3Headache 3.3

9.8Drowsiness 14.4

8.2Cardiovascular Palpitations 7.8

29.5Tachycardia 2.6 0 Respiratory Dyspnea 2 0 Chest discomfort 2.6 0 Gastrointestinal Nausea/vomiting 1.3

11.5Systemic Weakness 2.6

1.6Flushed feeling 1.3 0 Sweating 0 0 Pain at injection site 2.6

1.6Note: Some patients received more than one dosage strength of terbutaline and epinephrine. In addition, there were reports of anxiety, muscle cramps, and dry mouth (<0.5%). There have been rare reports of elevations in liver enzymes and of hypersensitivity vasculitis with terbutaline administration.

🆘 Overdosage 168 words ▾

OVERDOSAGE The median sc lethal dose of terbutaline in mature rats was approximately 165 mg/kg (approximately 2,700 times the maximum recommended daily sc dose for adults on a mg/m 2 basis). The median sc lethal dose of terbutaline in young rats was approximately 2,000 mg/kg (approximately 32,000 times the maximum recommended daily sc dose for adults on a mg/m 2 basis). The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS , e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia.

Hypokalemia may also occur. There is no specific antidote. Treatment consists of discontinuation of terbutaline together with appropriate symptomatic therapy.

The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of terbutaline.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Terbutaline is a beta-adrenergic receptor agonist. In vitro and in vivo pharmacologic studies have demonstrated that terbutaline exerts a preferential effect on beta 2 -adrenergic receptors. While it is recognized that beta 2 -adrenergic receptors are the predominant receptors in bronchial smooth muscle, data indicate that there is a population of beta 2 -receptors in the human heart, existing in a concentration between 10% to 50%.

The precise function of these receptors has not been established (see WARNINGS ). Controlled clinical studies in patients given terbutaline subcutaneously have not revealed a preferential beta 2 -adrenergic effect. The pharmacologic effects of beta-adrenergic agonists, including terbutaline, are at least in part attributable to stimulation through beta-adrenergic receptors of intracellular adenyl cyclase, the enzyme which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic 3’,5’-adenosine monophosphate (cAMP).

Increased cAMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. Controlled clinical studies have shown that terbutaline relieves bronchospasm in acute and chronic obstructive pulmonary disease by significantly increasing pulmonary flow rates (e.g., an increase of 15% or more in FEV 1 ). After subcutaneous administration of 0.25 mg of terbutaline, a measurable change in expiratory flow rate usually occurs within 5 minutes, and a clinically significant increase in FEV 1 occurs within 15 minutes.

The maximum effect usually occurs within 30 to 60 minutes, and clinically significant bronchodilator activity may continue for 1.5 to 4 hours. The duration of clinically significant improvement is comparable to that observed with equimilligram doses of epinephrine. Preclinical Studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrhythmias and sudden death (with histological evidence of myocardial necrosis) when beta-agonists and methylxanthines are administered concurrently.

The clinical significance of these findings is unknown. Pharmacokinetics Subcutaneous administration of 0.5 mg of terbutaline to 17 healthy, adult, male subjects resulted in mean (SD) peak plasma terbutaline concentration of 9.6 (3.6) ng/mL, which was observed at a median (range) time of 0.5 (0.08 to 1) hours after dosing. The mean (SD) AUC (0 to 48) and total body clearance values were 29.4 (14.2) hr • ng/mL, and 311 (112) mL/min respectively.

The terminal half-life was determined in 9 of the 17 subjects and had a mean (SD) of 5.7 (2) hours. After subcutaneous administration of 0.25 mg of terbutaline to two male subjects, peak terbutaline serum concentrations of 5.2 and 5.3 ng/mL were observed at about 20 minutes after dosing. Elimination half-life of the drug in 10 of 14 patients was approximately 2.9 hours after subcutaneous administration, but longer elimination half-lives (between 6 to 14 hours) were found in the other 4 patients.

About 90% of the drug was excreted in the urine at 96 hours after subcutaneous administration, with about 60% of this being unchanged drug. It appears that the sulfate conjugate is a major metabolite of terbutaline and urinary excretion is the primary route of elimination.

Preclinical Studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrhythmias and sudden death (with histological evidence of myocardial necrosis) when beta-agonists and methylxanthines are administered concurrently. The clinical significance of these findings is unknown.

Pharmacokinetics Subcutaneous administration of 0.5 mg of terbutaline to 17 healthy, adult, male subjects resulted in mean (SD) peak plasma terbutaline concentration of 9.6 (3.6) ng/mL, which was observed at a median (range) time of 0.5 (0.08 to 1) hours after dosing. The mean (SD) AUC (0 to 48) and tota… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 72 words ▾

HOW SUPPLIED Terbutaline Sulfate Injection, USP Product Code Unit of Sale Strength Each 660501 NDC 63323-665-01 Unit of 25 1 mg per mL NDC 63323-665-00 2 mL Amber, Type 1 Glass Single Dose Vial Discard unused portion after single patient use. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Do not use if solution is discolored. Vial stoppers do not contain natural rubber latex.

📋 Description 132 words ▾

DESCRIPTION Terbutaline Sulfate Injection, USP, is a beta-adrenergic agonist bronchodilator available as a sterile, nonpyrogenic, aqueous solution in vials, for subcutaneous administration. Each mL of solution contains: 1 mg of terbutaline sulfate USP (0.82 mg of the free base), and Water for Injection, USP. Sodium chloride is used for isotonicity, and hydrochloric acid for adjustment to a pH of 3.0 to 5.0.

Terbutaline sulfate is (±)-α-[( tert -butyl-amino) methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1) (salt). The structural formula is: (C 12 H 19 NO 3 ) 2 • H 2 SO 4 M.W. 548.65 Terbutaline sulfate USP is a white to gray-white crystalline powder.

It is odorless or has a faint odor of acetic acid. It is soluble in water and in 0.1N hydrochloric acid, slightly soluble in methanol, and insoluble in chloroform. structure

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Terbutaline, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, including ischemic heart disease, hypertension, and cardiac arrhythmias; in patients with hyperthyroidism or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines or who have convulsive disorders. Significant changes in systolic and diastolic blood pressure have been seen and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator.

Immediate hypersensitivity reactions and exacerbations of bronchospasm have been reported after terbutaline administration. Beta-adrenergic agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation.

Large doses of intravenous terbutaline have been reported to aggravate pre-existing diabetes mellitus and ketoacidosis. Drug Interactions The concomitant use of terbutaline with other sympathomimetic agents is not recommended, since the combined effect on the cardiovascular system may be deleterious to the patient. Monoamine Oxidase Inhibitors or Tricyclic Antidepressants Terbutaline should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, since the action of terbutaline on the vascular system may be potentiated.

Beta-Blockers Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as terbutaline, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma.

In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution. Diuretics The ECG changes and/or hypokalemia that may result from the administration of non-potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with non-potassium-sparing diuretics.

Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year study in Sprague-Dawley rats, terbutaline sulfate caused a significant and dose-related increase in the incidence of benign leiomyomas of the mesovarium at dietary doses of 50 mg/kg and above (approximately 810 times the maximum recommended daily subcutaneous (sc) dose for adults on a mg/m 2 basis). In a 21-month study in CD-1 mice, terbutaline showed no evidence of tumorigenicity at dietary doses up to 200 mg/kg (approximately 1,600 times the maximum recommended daily sc dose for adults on a mg/m 2 basis).

The mutagenicity potential of terbutaline has not been determined. Reproduction studies in rats using terbutaline demonstrated no impairment of fertility at oral doses up to 50 mg/kg (approximately 810 times the maximum recommended daily sc dose for adults on a mg/m 2 basis). Pregnancy: Teratogenic Effects Pregnancy Category C There are no adequate and well-controlled studies of terbutaline sulfate in pregnant women.

Published animal studies show that rat offspring exhibit alterations in behavior and brain development, including decreased cellular proliferation and differentiation when dams were treated subcutaneously with terbutaline during the late stage of pregnancy and lactation period. Terbutaline exposures in rat dams were approximately 24 to 48 times the common human dose in adults of 2 to 4 mg/day… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 106 words ▾

PACKAGE LABEL - PRINCIPAL DISPLAY – Terbutaline Sulfate 1 mL Single Dose Vial Label NDC 63323-665-00 660501 TERBUTALINE SULFATE INJECTION, USP 1 mg per mL For Subcutaneous Injection Only. Sterile Do not use if solution is discolored. Protect from light. Rx only 1 mL Single Dose Vial PDP INFO – TERBUTALINE SULFATE 402168C VIAL

PACKAGE LABEL - PRINCIPAL DISPLAY – Terbutaline Sulfate 1 mL Single Dose Vial Tray Label NDC 63323-665-01 660501 TERBUTALINE SULFATE INJECTION, USP 1 mg per mL For Subcutaneous Injection Only. Do not use if solution is discolored. Rx only 25 Single Dose Vials, 1 mL PDP INFO – TERBUTALINE SULFATE 42730C TRAY

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

Carcinogenesis, Mutagenesis, Impairment of Fertility: A label section reporting whether lab or animal studies found effects on cancer risk, genes, or the ability to have children.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

crossover: A study design in which each person takes one treatment for a time, then switches to the other, acting as their own comparison.

depression: A lasting low mood with loss of interest that affects everyday life.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

edema: Swelling caused by extra fluid trapped in the body's tissues.

electrocardiogram: A quick, painless test that records the heart's electrical activity to check its rhythm and rate.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

fertility: The natural ability to become pregnant or to father a child.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hyperglycemia: High blood sugar, meaning there is more glucose (sugar) in the blood than normal.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hyperthyroidism: A condition where the thyroid gland makes too much thyroid hormone, which can speed the body up.

hypoglycemia: Low blood sugar, when the amount of glucose (sugar) in the blood drops below the normal range.

hypokalemia: A lower-than-normal level of potassium, an important mineral, in the blood.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

ischemia: Reduced blood flow to a part of the body, so that area does not get enough oxygen.

lactation: The making and release of milk from a mother's breasts after giving birth.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

metabolite: A new substance formed when the body breaks a medicine down.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

palpitations: The feeling that your heart is racing, pounding, fluttering, or skipping beats.

parenteral: Given by injection or drip into the body rather than swallowed by mouth.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

prophylaxis: Treatment given to prevent an infection or illness before it starts, rather than to treat one that is already present.

pulmonary edema: A buildup of fluid in the lungs' air sacs that makes it hard to breathe.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

terminal half-life: The time it takes blood levels to fall by half during the final, slowest stage of removal.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q1 2026 · 5 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

1.7K

Units reimbursed last 4 qtrs

2K

Gross reimbursed last 4 qtrs

$62.5K

Avg / prescription

$37.16

Avg / unit

$31.3614

Latest quarter Q1 2026

316Rx

Fee-for-service vs managed care ⓘ

22% FFS 78% MCO

Fee-for-service · 373 Rx Managed care · 1,308 Rx

State Medicaid map

Units reimbursed · per 100k residents

0.12.5

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Iowa 2.5 /100k

2 Kentucky 2.4 /100k

3 Mississippi 2.1 /100k

4 Alabama 2.1 /100k

5 California 2.0 /100k

6 Tennessee 1.4 /100k

7 Louisiana 1.4 /100k

8 Nevada 1.1 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Terbutaline Sulfate — the program that covers self-administered drugs. 4 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Terbutaline Sulfate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$169.6K

Claims incl. refills

806

Beneficiaries

494

Spend / beneficiary

$343.42

Spend / claim

$210.48

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	✓ Available
Medicaid utilization (CMS SDUD)	✓ Available

“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 Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Fresenius Kabi USA, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

Does this product have a billing J-code?

Yes — this NDC cross-references HCPCS code J3105 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.

Related NDC lookups

🧪 All Terbutaline Sulfate NDCsSame ingredient 🏭 All Fresenius labeler NDCsLabeler code 63323 🧾 J3105 billing & NDC crosswalkJ-code

Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Beta-Adrenergic Agents.

Albuterol Sulfate 00378-0255-01

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

First Databank (licensed) · refreshed Oct 1, 2026

Terbutaline Sulfate 1 mg/mL Injection, Solution, 25 vials — NDC 63323-665-01 (Billing 63323-0665-01)

NDC database record

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

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

RxNorm drug class

Clinical

Patient education

Supplement & herbal interactions

Pricing

Billing & reimbursement

Packaging — all sizes for this product

Therapeutic equivalents

Availability & generic status

Inactive Ingredients / Excipients

Inactive ingredient FAQ

Manufacturer & labeler

More NDCs from Fresenius Kabi USA, LLC labeler code 63323

Full prescribing information FDA SPL

0.5 Flushed feeling 0

2.4 Sweating 0

Medicaid utilization & spend

Medicare Part D spend CMS · PART D · 2026 (Q1)

About this NDC listing & data coverage

Questions about this listing