Quick answers
- What is Terbutaline sulfate used for?
- The FDA-approved label (Terbutaline Sulfate, ANI Pharmaceuticals, Inc., November 15, 2019) says: “Terbutaline Sulfate Tablets USP are 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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Terbutaline sulfate have a boxed warning?
- Yes. The FDA label for Terbutaline Sulfate has a boxed warning (“WARNING: TOCOYSIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Terbutaline sulfate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Terbutaline sulfate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Terbutaline sulfate?
- 10 companies list prescription products of Terbutaline sulfate in the FDA NDC Directory, including Proficient Rx LP, Amneal Pharmaceuticals of New York LLC and Chartwell RX, LLC.
What Terbutaline sulfate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Terbutaline Sulfate Tablets USP are 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.
— FDA label: Terbutaline Sulfate, ANI Pharmaceuticals, Inc., effective November 15, 2019. Read the full label on DailyMed →
The FDA has 11 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: TOCOYSIS
. Read it on the full label →
10 of 11 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Injection · Injection, solution |
|---|---|
| Route | Oral · Subcutaneous |
| Prescription products | 17 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| terbutaline sulfate 2.5 mg tablet | Generic | $0.9257 per tablet |
| terbutaline sulfate 5 mg tablet | Generic | $0.5862 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Proficient Rx LP2 products
- Amneal Pharmaceuticals of New York LLC2 products
- Chartwell RX, LLC2 products
- ANI Pharmaceuticals, Inc.2 products
- Upsher-Smith Laboratories, LLC2 products
- Hikma Pharmaceuticals USA Inc.2 products
- Lannett Company, Inc.2 products
- Henry Schein, Inc.1 product
- Medical Purchasing Solutions, LLC1 product
- Fresenius Kabi USA, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA017849 BRETHINE | Ani Pharms | May 17, 1976 | 35, latest April 8, 2011 2011: Labeling · 2003: Labeling · 2002: Manufacturing (CMC) |
Generic approvals (5)
- ANDA075877Impax Labs · June 26, 2001
- ANDA076887Fresenius Kabi USA · May 26, 2004
- ANDA077152Lannett Co Inc · March 25, 2005
- ANDA078630Hikma Farmaceutica · May 20, 2009
- ANDA211832Twi Pharms · June 19, 2020
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 857635, 857677, 857683 |
|---|---|
| SPL set ID of the quoted label | d810a15b-3e10-4f6c-a36e-8ddecbaba9c3 |
| FDA labels (SPL) | 11 |
| FDA applications | NDA017849, 5 ANDA |
| Active ingredients (FDA) | TERBUTALINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Terbutaline Sulfate, ANI Pharmaceuticals, Inc., effective November 15, 2019; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →