Bupropion Hydrochloride (XL) 150 mg Tablet, Extended Release, 500-count
Other active recalls for Bupropion Hydrochloride (different manufacturers) — 3 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Aminoketone class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- Bupropion is an antidepressant primarily used to treat major depressive disorder — that's clinical depression. Depending on which formulation you're prescribed, it may also be used...
- Most people don't notice a full effect immediately — antidepressant treatment for depression typically requires several months or longer. Your dose may also be increased gradually...
- Will bupropion make me feel better right away?
- The most common ones are dry mouth, nausea, trouble sleeping, dizziness, headache, and feeling anxious or agitated — especially early on. Many of these improve as your body adjusts...
Patient education
Supplement & herbal interactions
Bupropion may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
-
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII NX76LV5T8J
A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
-
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
-
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
-
UNII 8MDF5V39QO
A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
-
UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
-
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
-
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
-
UNII 8Z96QXD6UM
Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
12 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.120 | $59.75 / 500 tablets |
| 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 · Q2 2026 | $0.3192 | $159.60 / 500 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Bupropion Hydrochloride 150 mg 68001-0519-03 | BluePoint | 500 tablets | $0.077 | AB3 | Availability likely | save 36% |
| Bupropion Hydrochloride (XL) 150 mg 24979-0101-02 | Upsher-Smith | 500 tablets | $0.078 | — | Discontinued | save 35% |
| Bupropion hydrochloride 150 mg 63304-0723-05 | Sun | 500 tablets | $0.079 | — | Discontinued | save 34% |
| Bupropion Hydrochloride XL 150 mg 00591-3331-05 | Actavis | 500 tablets | $0.079 | AB3 | Availability likely | save 34% |
| Bupropion Hydrochloride XL 150 mg 00904-7505-04 | Major | 1 tablet | $0.079 | AB3 | Availability likely | save 34% |
| bupropion hydrochloride 150 mg 16571-0862-03 | Rising | 30 tablets | $0.079 | AB3 | Availability likely | save 34% |
| Bupropion Hydrochloride 150 mg 16729-0443-10 | Accord | 30 tablets | $0.079 | AB3 | Availability likely | save 34% |
| Bupropion Hydrochloride 150 mg 31722-0487-05 | Camber | 500 tablets | $0.079 | AB3 | Availability likely | save 34% |
| Bupropion Hydrochloride XL 150 mg 42806-0348-05 | Epic | 500 tablets | $0.079 | AB3 | Availability likely | save 34% |
| Bupropion Hydrochloride XL 150 mg 42806-0414-05 | Epic | 500 tablets | $0.079 | AB3 | Availability likely | save 34% |
| Bupropion Hydrochloride (XL) 150 mg 50228-0144-05 | ScieGen | 500 tablets | $0.079 | AB3 | Availability likely | save 34% |
| Bupropion Hydrochloride 150 mg 50268-0133-13 | AvPAK | 1 tablet | $0.079 | AB3 | Availability likely | save 34% |
| Bupropion Hydrochloride 150 mg 60687-0782-01 | American | 1 tablet | $0.079 | AB3 | Availability likely | save 34% |
| Bupropion Hydrochloride (Xl) 150 mg 62135-0875-30 | Chartwell | 30 tablets | $0.079 | AB3 | Availability likely | save 34% |
| Bupropion hydrochloride 150 mg 68001-0613-03 | BluePoint | 500 tablets | $0.079 | AB3 | Availability likely | save 34% |
| Bupropion Hydrochloride XL 150 mg 68180-0319-02 | Lupin | 500 tablets | $0.079 | AB3 | Availability likely | save 34% |
| bupropion 150 mg 68382-0353-05 | Zydus | 500 tablets | $0.079 | AB3 | Availability likely | save 34% |
| Bupropion Hydrochloride 150 mg 69097-0071-12 | Cipla | 500 tablets | $0.079 | AB3 | Availability likely | save 34% |
| Bupropion Hydrochloride XL 150 mg 69367-0288-05 | Westminster | 500 tablets | $0.079 | AB3 | Discontinued | save 34% |
| Bupropion hydrochloride 150 mg 70010-0784-03 | Granules | 30 tablets | $0.079 | AB3 | Availability likely | save 34% |
| Bupropion Hydrochloride XL 150 mg 82009-0051-05 | Quallent | 500 tablets | $0.079 | AB3 | Availability likely | save 34% |
| Bupropion Hydrochloride (XL) 150 mg 83301-0024-01 | Mullan | 30 tablets | $0.079 | AB3 | Availability likely | save 34% |
| Bupropion Hydrochloride XL 150 mg 70436-0010-02 | Slate | 500 tablets | $0.079 | AB3 | Availability likely | save 34% |
| Bupropion Hydrochloride 150 mg 42806-0415-01 | Epic | 100 tablets | $0.082 | AB1 | Availability likely | save 31% |
| Bupropion Hydrochloride 150 mg 59651-0847-01 | Aurobindo | 100 tablets | $0.082 | AB1 | Availability likely | save 31% |
| Bupropion Hydrochloride SR 150 mg 00591-3541-05 | Actavis | 500 tablets | $0.082 | AB1 | Availability likely | save 31% |
| Bupropion hydrochloride 150 mg 31722-0067-01 | Camber | 100 tablets | $0.082 | AB1 | Availability likely | save 31% |
| Bupropion Hydrochloride SR 150 mg 42806-0425-01 | Epic | 100 tablets | $0.082 | AB1 | Availability likely | save 31% |
| BuPROPion Hydrochloride 150 mg 68084-0708-25 | American | 1 tablet | $0.082 | AB1 | Availability likely | save 31% |
| bupropion hydrochloride SR 150 mg 00904-7465-61 | Major | 1 tablet | $0.082 | AB1 | Availability likely | save 31% |
| Bupropion Hydrochloride SR 150 mg 50228-0175-01 | ScieGen | 100 tablets | $0.082 | AB1 | Availability likely | save 31% |
| Bupropion Hydrochloride SR 150 mg 43598-0752-01 | Dr. | 100 tablets | $0.082 | AB1 | Availability likely | save 31% |
| Bupropion Hydrochloride SR 150 mg 70436-0059-01 | Slate | 100 tablets | $0.084 | AB1 | FDA listed | save 30% |
| Bupropion Hydrochloride (XL) 150 mg 43598-0655-05 | Dr | 500 tablets | $0.108 | AB3 | FDA listed | save 10% |
| Bupropion hydrochloride (XL) 150 mg 00527-2415-32 | Lannett | 30 tablets | $0.119 | AB3 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mgthis 69097-0875-12 | CIPLA | 500 tablets | $0.119 | — | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 00591-3543-60 | Actavis | 60 tablets | $0.251 | AB2 | Availability likely | +110% |
| Bupropion Hydrochloride SR 150 mg 42806-0413-60 | Epic | 60 tablets | $0.251 | AB2 | Availability likely | +110% |
| Bupropion Hydrochloride 150 mg 00115-6811-02 | Amneal | 500 tablets | — | — | FDA listed | — |
| Wellbutrin Xl 150 mg 00187-0730-07 | Bausch | 7 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 00615-8504-05 | NCS | 15 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 47335-0954-13 | Sun | 500 tablets | — | — | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 50090-4049-00 | A-S | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 50090-4747-00 | A-S | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 50090-5163-00 | A-S | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 50090-6789-00 | A-S | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 50090-7109-00 | A-S | 90 tablets | — | — | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 50090-7110-00 | A-S | 90 tablets | — | — | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 50090-7112-00 | A-S | 90 tablets | — | AB3 | Discontinued | — |
| Bupropion Hydrochloride XL 150 mg 50090-7113-00 | A-S | 90 tablets | — | AB3 | Discontinued | — |
| Bupropion Hydrochloride 150 mg 50090-7711-00 | A-S | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 50090-7712-00 | A-S | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 51655-0098-26 | Northwind | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion HCL ER (XL) 150 mg 61919-0558-60 | Direct_Rx | 60 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 63187-0713-30 | Proficient | 30 tablets | — | — | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 63187-0766-30 | Proficient | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 63629-8474-01 | Bryant | 30 tablets | — | AB3 | FDA listed | — |
| bupropion 150 mg 65841-0836-05 | Zydus | 500 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 67046-0699-03 | Coupler | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 68071-3559-09 | NuCare | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 68071-3594-03 | NuCare | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 68071-3927-03 | NuCare | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 68071-3932-03 | NuCare | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion hydrochloride 150 mg 68788-4010-01 | Preferred | 100 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 68788-7786-01 | Preferred | 100 tablets | — | AB3 | FDA listed | — |
| Bupropion hydrochloride (XL) 150 mg 69680-0157-30 | Vitruvias | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 70518-2022-02 | REMEDYREPACK | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 70518-2458-00 | REMEDYREPACK | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 70518-3963-00 | REMEDYREPACK | 30 tablets | — | AB3 | Discontinued | — |
| Bupropion hydrochloride 150 mg 70518-4189-00 | REMEDYREPACK | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion hydrochloride 150 mg 70518-4448-00 | REMEDYREPACK | 30 tablets | — | AB3 | FDA listed | — |
| bupropion hydrochloride 150 mg 70518-4674-00 | REMEDYREPACK | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 71205-0291-30 | Proficient | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 71205-0394-30 | Proficient | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 71205-0504-30 | Proficient | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 71205-0967-30 | Proficient | 30 tablets | — | — | FDA listed | — |
| Bupropion Hydrochloride 150 mg 71335-1044-01 | Bryant | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 71335-2378-01 | Bryant | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion hydrochloride 150 mg 71335-2469-01 | Bryant | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 72162-1526-05 | Bryant | 500 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 72189-0134-30 | DIRECT | 30 tablets | — | AB3 | FDA listed | — |
| buPropion Hydrochloride XL 150 mg 72516-0035-03 | Oryza | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 72789-0120-90 | PD-Rx | 90 tablets | — | — | Discontinued | — |
| Bupropion Hydrochloride 150 mg 72789-0301-90 | PD-Rx | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 72789-0377-90 | PD-Rx | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 76282-0480-05 | Exelan | 500 tablets | — | — | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 76420-0923-01 | Asclemed | 100 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 77771-0144-05 | RADHA | 500 tablets | — | AB3 | FDA listed | — |
| Bupropion hydrochloride 150 mg 80425-0300-01 | Advanced | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 80425-0461-01 | Advanced | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 82804-0080-30 | Proficient | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion hydrochloride 150 mg 82804-0296-90 | Proficient | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 82868-0097-96 | Northwind | 180 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 83008-0082-30 | Quality | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride (SR) 150 mg 50228-0338-11 | ScieGen | 1000 tablets | — | AB2 | FDA listed | — |
| Bupropion hydrochloride 150 mg 63187-0052-30 | Proficient | 30 tablets | — | — | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 63187-0726-30 | Proficient | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride (Sr) 150 mg 69097-0878-02 | Cipla | 30 tablets | — | — | FDA listed | — |
| bupropion 150 mg 71205-0565-30 | Proficient | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 71610-0576-30 | Aphena | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 43598-0537-01 | Dr. | 100 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 50090-1150-00 | A-S | 60 tablets | — | AB2 | FDA listed | — |
| bupropion 150 mg 51655-0357-26 | Northwind | 90 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride (Sr) 150 mg 43598-0863-10 | Dr. | 1000 tablets | — | AB2 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 50090-6871-00 | A-S | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 70518-4081-01 | REMEDYREPACK | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 71335-2457-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 71610-0990-30 | Aphena | 30 tablets | — | AB1 | FDA listed | — |
| bupropion hydrochloride SR 150 mg 55154-0183-00 | Cardinal | 1 tablet | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride (Sr) 150 mg 50090-5101-00 | A-S | 60 tablets | — | AB2 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 68788-7807-01 | Preferred | 100 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 70010-0126-03 | Granules | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 71335-1837-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| bupropion hydrochloride SR 150 mg 43547-0289-06 | Solco | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 50090-7423-00 | A-S | 90 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 51655-0115-25 | Northwind | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 00615-8602-39 | NCS | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride Sr 150 mg 43063-0744-30 | PD-Rx | 30 tablets | — | — | FDA listed | — |
| Bupropion Hydrochloride 150 mg 50090-6353-00 | A-S | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 71335-0135-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 50090-6872-00 | A-S | 90 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 63629-8473-01 | Bryant | 500 tablets | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 68788-8769-01 | Preferred | 100 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 71335-1702-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 72162-1529-05 | Bryant | 500 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 43063-0913-30 | PD-Rx | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 50090-7322-00 | A-S | 60 tablets | — | AB2 | Discontinued | — |
| Bupropion Hydrochloride SR 150 mg 77771-0175-05 | Radha | 500 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 82868-0019-60 | Northwind | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 47335-0737-08 | Sun | 100 tablets | — | — | FDA listed | — |
| Bupropion hydrochloride 150 mg 50090-7422-00 | A-S | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 68071-2890-03 | NuCare | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 70518-4056-01 | REMEDYREPACK | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 71205-0550-30 | Proficient | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 67046-1273-03 | Coupler | 30 tablets | — | AB1 | FDA listed | — |
| bupropion hydrochloride 150 mg 71335-3153-01 | Bryant | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 59651-0511-05 | Aurobindo | 500 tablets | — | AB3 | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 69097-0875-02 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69097-875-02) | $0.1195 / ea | $3.58 | 2016-08-29 | Active |
| 69097-0875-05 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69097-875-05) | $0.0787 / ea | $7.08 | 2016-08-29 | Active |
| 69097-0875-12 You're viewing this | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69097-875-12) | $0.1195 / ea | $59.74 | 2016-08-29 | Active |
You're viewing the largest of 3 pack sizes for this product.
Per ea, this pack runs about 52% above the cheapest pack (90-count, $0.0787 vs $0.1195 NADAC).
Pack size FAQ
What quantity is in NDC 69097-0875-12?
What is the difference between NDC 69097-0875-12 and NDC 69097-0875-02?
What NDC number is used to bill for this package of Bupropion Hydrochloride (XL) 150 mg Tablet, Extended Release?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects aged 65 and older [ see Warnings and Precautions (5.1) ]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors.
Advise families and caregivers of the need for close observation and communication with the prescriber [ see Warnings and Precautions (5.1) ]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants.
Monitor for worsening and emergence of suicidal thoughts and behaviors. ( 5.1 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablet, (XL) is an aminoketone antidepressant, indicated for treatment of major depressive disorder (MDD) ( 1.1 ) prevention of seasonal affective disorder (SAD) ( 1.2 )
1.1Major Depressive Disorder (MDD) Bupropion hydrochloride extended-release tablets, (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [ see Clinical Studies (14.1) ].
1.2Seasonal Affective Disorder (SAD) Bupropion hydrochloride extended-release tablets, (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). The efficacy of bupropion hydrochloride extended-release tablets, (XL) in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM [ see Clinical Studies (14.2) ].
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION General : • Increase dose gradually to reduce seizure risk. ( 2.1 , 5.3 ) • Periodically reassess the dose and need for maintenance treatment. ( 2.2 ) Major Depressive Disorder • Starting dose: 150 mg once daily.
Usual target dose: 300 mg once daily ( 2.2 ) • After 4 days, may increase the dose to 300 mg once daily. ( 2.2 ) Seasonal Affective Disorder • Initiate treatment in the autumn prior to onset of seasonal depressive symptoms. ( 2.3 ) • Starting dose: 150 mg once daily.
Usual target dose: 300 mg once daily. ( 2.3 ) • After one week, may increase the dose to 300 mg once daily. ( 2.3 ) • Continue treatment through the winter season.
( 2.3 ) Hepatic Impairment • Moderate to severe hepatic impairment: 150 mg every other day ( 2.6 ) • Mild hepatic impairment: Consider reducing the dose and/or frequency of dosing. ( 2.6 , 8.7 ) Renal Impairment • Consider reducing the dose and/or frequency of dosing. ( 2.7, 8.6 )
2.1General Instructions for Use To minimize the risk of seizure, increase the dose gradually [ see Warnings and Precautions (5.3) ]. Bupropion hydrochloride extended-release tablets, (XL) should be swallowed whole and not crushed, divided, or chewed. Bupropion hydrochloride extended-release tablets, (XL) should be administered in the morning and may be taken with or without food.
2.2Dosage for Major Depressive Disorder (MDD) The recommended starting dose for MDD is 150 mg once daily in the morning. After 4 days of dosing, the dose may be increased to the target dose of 300 mg once daily in the morning . It is generally agreed that acute episodes of depression require several months or longer of antidepressant treatment beyond the response in the acute episode.
It is unknown whether the bupropion hydrochloride extended-release tablets, (XL) dose needed for maintenance treatment is identical to the dose that provided an initial response. Periodically reassess the need for maintenance treatment and the appropriate dose for such treatment .
2.3Dosage for Seasonal Affective Disorder (SAD) The recommended starting dose for SAD is 150 mg once daily. After 7 days of dosing, the dose may be increased to the target dose of 300 mg once daily in the morning. Doses above 300 mg of bupropion hydrochloride extended-release tablets, (XL) were not assessed in the SAD trials.
For the prevention of seasonal MDD episodes associated with SAD, initiate bupropion hydrochloride extended-release tablets, (XL) in the autumn, prior to the onset of depressive symptoms. Continue treatment through the winter season. Taper and discontinue bupropion hydrochloride extended-release tablets, (XL) in early spring.
For patients treated with 300 mg per day, decrease the dose to 150 mg once daily before discontinuing bupropion hydrochloride extended-release tablets, (XL). Individualize the timing of initiation, and duration of treatment should be individualized, based on the patient’s historical pattern of seasonal MDD episodes.
2.4Switching Patients from WELLBUTRIN ® (bupropion hydrochloride tablets) or from WELLBUTRIN SR ® (bupropion hydrochloride sustained-release tablets (SR)) When switching patients from WELLBUTRIN ® (bupropion hydrochloride tablets) or from WELLBUTRIN SR ® (bupropion hydrochloride sustained-release tablets (SR)) to bupropion hydrochloride extended-release tablets, (XL), give the same total daily dose when possible .
2.5To Discontinue Bupropion Hydrochloride Extended-Release Tablets (XL), Taper the Dose When discontinuing treatment in patients treated with bupropion hydrochloride extended-release tablets, (XL) 300 mg once daily, decrease the dose to 150 mg once daily prior to discontinuation.
2.6Dosage Adjustment in Patients with Hepatic Impairment In patients with moderate to severe hepatic impairment (Child-Pugh score: 7 to 15), the maximum dose is 150 mg every other day . In patients with mild hepatic impairment (Child-Pugh score: 5 to 6), consider reducing the dose and/or frequency of dosing [see…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Bupropion hydrochloride extended-release tablets USP (XL), 150 mg are white to off white capsule shaped, biconvex coated tablets de-bossed with ‘I’ on one side and ‘13’ on the other side . Bupropion hydrochloride extended-release tablets USP (XL), 300 mg are white to off white capsule shaped, biconvex coated tablets de-bossed with ‘I 71’ on one side and plain on the other side . Extended-release tablets: 150 mg, 300 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with seizure disorder. Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with bupropion hydrochloride extended-release tablets (XL) [ see Warnings and Precautions (5.3) ]. Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [ see Warnings and Precautions (5.3) and Drug Interactions (7.3) ].
The use of MAOIs (intended to treat psychiatric disorders) concomitantly with bupropion hydrochloride extended-release tablets (XL) or within 14 days of discontinuing treatment with bupropion hydrochloride extended-release tablets (XL) are contraindicated. There is an increased risk of hypertensive reactions when bupropion hydrochloride extended-release tablets (XL) are used concomitantly with MAOIs. The use of bupropion hydrochloride extended-release tablets (XL) within 14 days of discontinuing treatment with an MAOI is also contraindicated.
Starting bupropion hydrochloride extended-release tablets (XL) in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated [ see Dosage and Administration (2.9) , Warnings and Precautions (5.4) and Drug Interactions (7.6) ]. Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with known hypersensitivity to bupropion or other ingredients of bupropion hydrochloride extended-release tablets (XL). Anaphylactoid/anaphylactic reactions and Stevens-Johnson Syndrome have been reported [ see Warnings and Precautions (5.8) ].
Seizure disorder. ( 4 , 5.3 ) Current or prior diagnosis of bulimia or anorexia nervosa ( 4 , 5.3 ) Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, antiepileptic drugs. ( 4 , 5.3 ) Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with bupropion or within 14 days of stopping treatment with bupropion.
Do not use bupropion within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start bupropion in a patient who is being treated with linezolid or intravenous methylene blue. ( 4 , 7.6 ) Known hypersensitivity to bupropion or other ingredients of bupropion hydrochloride extended-release tablets (XL) ( 4 , 5.8 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Neuropsychiatric Adverse Events During Smoking Cessation: Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients attempting to quit smoking with bupropion for the occurrence of such symptoms and instruct them to discontinue bupropion hydrochloride extended-release tablets and contact a healthcare provider if they experience such adverse events.
( 5.2 ) Seizure Risk: The risk is dose-related. Can minimize risk by limiting daily dose to 450 mg and gradually increasing the dose. Discontinue if seizure occurs.
( 4 , 5.3 , 7.3 ) Hypertension: Bupropion can increase blood pressure. Monitor blood pressure before initiating treatment and periodically during treatment. ( 5.4 ) Activation of Mania/Hypomania: Screen patients for bipolar disorder and monitor for these symptoms.
( 5.5 ) Psychosis and Other Neuropsychiatric Reactions: Instruct patients to contact a healthcare professional if such reactions occur. ( 5.6 ) Angle-Closure Glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ( 5.7 )
5.1Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.
There has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (Selective Serotonin Reuptake Inhibitors [SSRIs] and others) show that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders.
Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4,400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients.
There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications.
These risk differences (drug-placebo difference in the number of cases of suicidality per 1,000 patients treated) are provided in Table 1 . Table 1: Risk Differences in the Number of Suicidality Cases by Age Group in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range Drug-Placebo Difference in Number of Cases of Suici…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Suicidal thoughts and behaviors in children, adolescents, and young adults [ see Warnings and Precautions (5.1) ] • Neuropsychiatric adverse events and suicide risk in smoking cessation treatment [ see Warnings and Precautions (5.2) ] • Seizure [ see Warnings and Precautions (5.3) ] • Hypertension [ see Warnings and Precautions (5.4) ] • Activation of mania or hypomania [ see Warnings and Precautions (5.5) ] • Psychosis and other neuropsychiatric events [ see Warnings and Precautions (5.6) ] • Angle-Closure Glaucoma [ see Warnings and Precautions (5.7) ] • Hypersensitivity reactions [ see Warnings and Precautions (5.8) ] Most common adverse reactions are (incidence ≥5%; ≥2× placebo rate): dry mouth, nausea, insomnia, dizziness, pharyngitis, abdominal pain, agitation, anxiety, tremor, palpitation, sweating, tinnitus, myalgia, anorexia, urinary frequency, rash.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Commonly Observed Adverse Reactions in Controlled Clinical Trials of Sustained-Release Bupropion Hydrochloride Adverse reactions that occurred in at least 5% of patients treated with bupropion HCl sustained-release (300 mg and 400 mg per day) and at a rate at least twice the placebo rate are listed below.
300 mg/day of bupropion HCl sustained-release: anorexia, dry mouth, rash, sweating, tinnitus, and tremor. 400 mg/day of bupropion HCl sustained-release: abdominal pain, agitation, anxiety, dizziness, dry mouth, insomnia, myalgia, nausea, palpitation, pharyngitis, sweating, tinnitus, and urinary frequency. Bupropion hydrochloride extended-release tablets (XL) have been demonstrated to have similar bioavailability both to the immediate-release and sustained-release formulations of bupropion.
The information included under this subsection and under subsection 6.2 is based primarily on data from controlled clinical trials with the sustained-release and extended-release formulations of bupropion hydrochloride. Major Depressive Disorder Adverse Reactions Leading to Discontinuation of Treatment with Bupropion HCl Immediate-Release, Bupropion HCl Sustained-Release, and Bupropion HCl Extended-Release in Major Depressive Disorder Trials In placebo-controlled clinical trials with bupropion HCl sustained-release, 4%, 9%, and 11% of the placebo, 300 mg/day and 400 mg/day groups, respectively, discontinued treatment because of adverse reactions.
The specific adverse reactions leading to discontinuation in at least 1% of the 300 mg/day or 400 mg/day groups and at a rate at least twice the placebo rate are listed in Table 2. Table 2: Treatment Discontinuation Due to Adverse Reactions in Placebo-Controlled Trials in MDD Adverse Reaction Term Placebo ( n = 385 ) Bupropion HCl Sustained - Release 300 mg / day ( n = 376 ) Bupropion HCl Sustained - Release 400 mg / day ( n = 114 ) Rash 0.0% 2.4% 0.9% Nausea 0.3% 0.8% 1.8% Agitation 0.3% 0.3% 1.8% Migraine 0.3% 0.0% 1.8% In clinical trials with bupropion HCl immediate-release, 10% of patients and volunteers discontinued due to an adverse reaction.
Reactions resulting in discontinuation (in addition to those listed above for the sustained-release formulation) included vomiting, seizures, and sleep disturbances. Adverse Reactions Occurring at an Incidence of >1% in Patients Treated with Bupropion HCl Immediate-Release or Bupropion HCl Sustained-Release in MDD Table 3 summarizes the adverse reactions that occurred in placebo-controlled trials in patients treated with bupropion HCl sustained-release 300 mg/…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS CYP2B6 inducers: Dose increase may be necessary if coadministered with CYP2B6 inducers (e.g., ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, and phenytoin) based on clinical exposure, but should not exceed the maximum recommended dose. ( 7.1 ) Drugs metabolized by CYP2D6: Bupropion inhibits CYP2D6 and can increase concentrations of: antidepressants (e.g., venlafaxine, nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, sertraline), antipsychotics (e.g., haloperidol, risperidone, thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone, flecainide).
Consider dose reduction when using with bupropion. ( 7.2 ) Drugs that lower seizure threshold: Dose bupropion with caution. ( 5.3 , 7.3 ) Dopaminergic Drugs (levodopa and amantadine): CNS toxicity can occur when used concomitantly with bupropion.
( 7.4 ) MAOIs: Increased risk of hypertensive reactions can occur when used concomitantly with bupropion. ( 7.6 ) Drug-laboratory test interactions: Bupropion can cause false-positive urine test results for amphetamines. ( 7.7 )
7.1Potential for Other Drugs to Affect Bupropion Hydrochloride Extended-Release Tablets (XL) Bupropion is primarily metabolized to hydroxybupropion by CYP2B6. Therefore, the potential exists for drug interactions between bupropion and drugs that are inhibitors or inducers of CYP2B6. Inhibitors of CYP2B6 Ticlopidine and Clopidogrel: Concomitant treatment with these drugs can increase bupropion exposures but decrease hydroxybupropion exposure.
Based on clinical response, dosage adjustment of bupropion may be necessary when coadministered with CYP2B6 inhibitors (e.g., ticlopidine or clopidogrel) [ see Clinical Pharmacology (12.3) ]. Inducers of CYP2B6 Ritonavir, Lopinavir, and Efavirenz: Concomitant treatment with these drugs can decrease bupropion and hydroxybupropion exposure. Dosage increase of bupropion may be necessary when coadministered with ritonavir, lopinavir, or efavirenz but should not exceed the maximum recommended dose [ see Clinical Pharmacology (12.3) ].
Carbamazepine, Phenobarbital, Phenytoin: While not systemically studied, these drugs may induce metabolism of bupropion and may decrease bupropion exposure [ see Clinical Pharmacology (12.3) ]. If bupropion is used concomitantly with a CYP inducer, it may be necessary to increase the dose of bupropion, but the maximum recommended dose should not be exceeded.
7.2Potential for Bupropion Hydrochloride Extended-Release Tablets (XL) to Affect Other Drugs Drugs Metabolized by CYP2D6 Bupropion and its metabolites (erythrohydrobupropion, threohydrobupropion, hydroxybupropion) are CYP2D6 inhibitors. Therefore, coadministration of bupropion with drugs that are metabolized by CYP2D6 can increase the exposures of drugs that are substrates of CYP2D6. Such drugs include certain antidepressants (e.g., venlafaxine, nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, and sertraline), antipsychotics (e.g., haloperidol, risperidone, and thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone, and flecainide).
When used concomitantly with bupropion, it may be necessary to decrease the dose of these CYP2D6 substrates, particularly for drugs with a narrow therapeutic index. Drugs that require metabolic activation by CYP2D6 to be effective (e.g., tamoxifen), theoretically could have reduced efficacy when administered concomitantly with inhibitors of CYP2D6 such as bupropion. Patients treated concomitantly with bupropion and such drugs may require increased doses of the drug [ see Clinical Pharmacology (12.3) ].
7.3Drugs That Lower Seizure Threshold Use extreme caution when coadministering bupropion with other drugs that lower the seizure threshold (e.g., other bupropion products, antipsychotics, antidepressants, theophylline, or systemic corticosteroids). Use low initial doses of bupropion and increase the dose gradually [ see Warnings…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/antidepressants/. Risk Summary Data from epidemiological studies of pregnant women exposed to bupropion hydrochloride extended release tablets in the first trimester have not identifies an increased risk of congenital malformations over all (see Data) There are risks to the mother associated with untreated depression (see Clinical Considerations).
When bupropion hydrochloride extended release tablets was administered to pregnant rats during organogenesis, there was no evidence of fetal malformations at doses up to approximately 10 times the maximum recommended human dose (MRHD) of 450 mg/day. When given to pregnant rabbits during organogenesis, non-dose-related increases in incidence of fetal malformations and skeletal variations were observed at doses approximately equal to the MRHD and greater. Decreased fetal weights were seen at doses twice the MRHD and greater (see Animal Data).
The estimated background risk for major birth defects and miscarriage are unknown for the indicated population. All pregnancies" should be ". All pregnancies have a background rate of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20% respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants during pregnancy at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants.
Consider the risks to the mother of untreated depression and potential effects of the fetus when discontinuing or changing treatment with antidepressant medications during pregnancy and postpartum. DATA Human Data Data from the international bupropion hydrochloride extended release tablets Pregnancy Registry (675 first trimester exposures) and a retrospective cohort study using the United Healthcare database (1,213 first trimester exposures) did not show an increased risk for malformations overall. The Registry was not designed or powered to evaluate specific defects but suggested a possible increase in cardiac malformations.
No increased risk for cardiovascular malformations overall has been observed after bupropion hydrochloride extended release tablets exposure during the first trimester. The prospectively observed rate of cardiovascular malformations in pregnancies with exposure to bupropion hydrochloride extended release tablets in the first trimester from the international Pregnancy Registry was 1.3% (9 cardiovascular malformations/675 first-trimester maternal bupropion exposures), which is similar to the background rate of cardiovascular malformations (approximately 1%).
Data from the United Healthcare database, which has a limited number of exposed cases with cardiovascular malformations, and a case-controlled study (6,853 infants with cardiovascular malformations and 5,753 with non- cardiovascular malformations) from the National Birth Defects Prevention Study (NBDPS) did not show an increased risk for cardiovascular malformations overall after bupropion exposure during the first trimester. Study findings on bupropion exposure during the first trimester and risk left ventricular outflow tract obstruction (LVOTO) are inconsistent and do not allow conclusions regarding possible a…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/antidepressants/. Risk Summary Data from epidemiological studies of pregnant women exposed to bupropion hydrochloride extended release tablets in the first trimester have not identifies an increased risk of congenital malformations over all (see Data) There are risks to the mother associated with untreated depression (see Clinical Considerations).
When bupropion hydrochloride extended release tablets was administered to pregnant rats during organogenesis, there was no evidence of fetal malformations at doses up to approximately 10 times the maximum recommended human dose (MRHD) of 450 mg/day. When given to pregnant rabbits during organogenesis, non-dose-related increases in incidence of fetal malformations and skeletal variations were observed at doses approximately equal to the MRHD and greater. Decreased fetal weights were seen at doses twice the MRHD and greater (see Animal Data).
The estimated background risk for major birth defects and miscarriage are unknown for the indicated population. All pregnancies" should be ". All pregnancies have a background rate of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20% respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants during pregnancy at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants.
Consider the risks to the mother of untreated depression and potential effects of the fetus when discontinuing or changing treatment with antidepressant medications during pregnancy and postpartum. DATA Human Data Data from the international bupropion hydrochloride extended release tablets Pregnancy Registry (675 first trimester exposures) and a retrospective cohort study using the United Healthcare database (1,213 first trimester exposures) did not show an increased risk for malformations overall. The Registry was not designed or powered to evaluate specific defects but suggested a possible increase in cardiac malformations.
No increased risk for cardiovascular malformations overall has been observed after bupropion hydrochloride extended release tablets exposure during the first trimester. The prospectively observed rate of cardiovascular malformations in pregnancies with exposure to bupropion hydrochloride extended release tablets in the first trimester from the international Pregnancy Registry was 1.3% (9 cardiovascular malformations/675 first-trimester maternal bupropion exposures), which is similar to the background rate of cardiovascular malformations (approximately 1%).
Data from the United Healthcare database, which has a limited number of exposed cases with cardiovascular malformations, and a case-controlled study (6,853 infants with cardiovascular malformations and 5,753 with non- cardiovascular malformations) from the National Birth Defects Prevention Study (NBDPS) did not show an increased risk for cardiovascular malformations overall after bupropion exposure during the first trimester. Study findings on bupropion exposure during the first trimester and risk left ventricular outflow tract obstruction (LVOTO) are inconsistent and do not allow conclusions regarding possible association.
The United Healthc…
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in the pediatric population have not been established. When considering the use of bupropion in a child or adolescent, balance the potential risks with the clinical need [ see Boxed Warning and Warnings and Precautions (5.1) ].
🧓 Geriatric Use ▾
8.5Geriatric Use Of the approximately 6,000 patients who participated in clinical trials with bupropion hydrochloride sustained-release tablets (depression and smoking cessation studies), 275 were ≥65 years old and 47 were ≥75 years old. In addition, several hundred patients ≥65 years of age participated in clinical trials using the immediate-release formulation of bupropion hydrochloride (depression studies). No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
Reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Bupropion is extensively metabolized in the liver to active metabolites, which are further metabolized and excreted by the kidneys. The risk of adverse reactions may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, it may be necessary to consider this factor in dose selection; it may be useful to monitor renal function [ see Dosage and Administration (2.7) , Use in Specific Populations (8.6) , and Clinical Pharmacology (12.3) ].
🆘 Overdosage ▾
10 OVERDOSAGE
10.1Human Overdose Experience Overdoses of up to 30 grams or more of bupropion have been reported. Seizure was reported in approximately one third of all cases. Other serious reactions reported with overdoses of bupropion alone included hallucinations, loss of consciousness, sinus tachycardia, and ECG changes such as conduction disturbances or arrhythmias.
Fever, muscle rigidity, rhabdomyolysis, hypotension, stupor, coma, and respiratory failure have been reported mainly when bupropion was part of multiple drug overdoses . Although most patients recovered without sequelae, deaths associated with overdoses of bupropion alone have been reported in patients ingesting large doses of the drug. Multiple uncontrolled seizures, bradycardia, cardiac failure, and cardiac arrest prior to death were reported in these patients .
10.2Overdosage Management Consult a Certified Poison Control Center for up-to-date guidance and advice. Telephone numbers for certified poison control centers are listed in the Physicians’ Desk Reference (PDR). Call 1-800-222-1222 or refer to www.poison.org. There are no known antidotes for bupropion. In case of an overdose, provide supportive care, including close medical supervision and monitoring. Consider the possibility of multiple drug overdose.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism of action of bupropion is unknown, as is the case with other antidepressants. However, it is presumed that this action is mediated by noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal uptake of norepinephrine and dopamine and does not inhibit monoamine oxidase or the reuptake of serotonin.
12.3Pharmacokinetics Bupropion is a racemic mixture. The pharmacologic activity and pharmacokinetics of the individual enantiomers have not been studied. Following chronic dosing, the mean steady-state plasma concentration of bupropion was reached within 8 days.
The mean elimination half-life (±SD) of bupropion is 21 (±9) hours. In a study comparing 14-day dosing with bupropion hydrochloride extended-release tablets (XL), 300 mg once-daily to the immediate-release formulation of bupropion at 100 mg 3 times daily, equivalence was demonstrated for peak plasma concentration and area under the curve for bupropion and the three metabolites (hydroxybupropion, threohydrobupropion, and erythrohydrobupropion). Additionally, in a study comparing 14-day dosing with bupropion hydrochloride extended-release tablets (XL) 300 mg once daily to the sustained-release formulation of bupropion at 150 mg 2 times daily, equivalence was demonstrated for peak plasma concentration and area under the curve for bupropion and the three metabolites.
Ab sorption Following single oral administration of bupropion hydrochloride extended-release tablets (XL) to healthy volunteers, the median time to peak plasma concentrations for bupropion was approximately 5 hours. The presence of food did not affect the peak concentration or area under the curve of bupropion. Distribution In vitro tests show that bupropion is 84% bound to human plasma proteins at concentrations up to 200 mcg/mL.
The extent of protein binding of the hydroxybupropion metabolite is similar to that for bupropion, whereas the extent of protein binding of the threohydrobupropion metabolite is about half that of bupropion. M e tabolism Bupropion is extensively metabolized in humans. Three metabolites are active: hydroxybupropion, which is formed via hydroxylation of the tert-butyl group of bupropion, and the amino-alcohol isomers threohydrobupropion and erythrohydrobupropion, which are formed via reduction of the carbonyl group.
In vitro findings suggest that CYP2B6 is the principal isoenzyme involved in the formation of hydroxybupropion, while cytochrome P450 enzymes are not involved in the formation of threohydrobupropion. Oxidation of the bupropion side chain results in the formation of a glycine conjugate of meta-chlorobenzoic acid, which is then excreted as the major urinary metabolite. The potency and toxicity of the metabolites relative to bupropion have not been fully characterized.
However, it has been demonstrated in an antidepressant screening test in mice that hydroxybupropion is one half as potent as bupropion, while threohydrobupropion and erythrohydrobupropion are 5-fold less potent than bupropion. This may be of clinical importance, because the plasma concentrations of the metabolites are as high or higher than those of bupropion. At steady state, peak plasma concentration of hydroxybupropion occurred approximately 7 hours after administration of bupropion hydrochloride extended-release tablets (XL), and it was approximately 7 times the peak level of the parent drug.
The elimination half-life of hydroxybupropion is approximately 20 (±5) hours, and its AUC at steady state is about 13 times that of bupropion. The times to peak concentrations for the erythrohydrobupropion and threohydrobupropion metabolites are similar to that of hydroxybupropion. However, the elimination half-lives of erythrohydrobupropion and threohydrobupropion are longer, approximately 33 (±10) and 37 (±13) hours, respectively, and steady-state AUCs were 1.4 and 7 times that of bupropion, respectively.
Bupropion a…
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism of action of bupropion is unknown, as is the case with other antidepressants. However, it is presumed that this action is mediated by noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal uptake of norepinephrine and dopamine and does not inhibit monoamine oxidase or the reuptake of serotonin.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Bupropion hydrochloride extended-release tablets, USP (XL), 150 mg are white to off white capsule shaped, biconvex coated tablets de-bossed with ‘I’ on one side and ‘13’ on the other side and are available in bottles of 30 tablets (NDC 69097-875-02), bottles of 90 tablets (NDC 69097-875-05) and bottles of 500 tablets (NDC 69097-875-12). Bupropion hydrochloride extended-release tablets, USP (XL), 300 mg are white to off white capsule shaped, biconvex coated tablets de-bossed with ‘I 71’ on one side and plain on the other side and are available in bottles of 30 tablets (NDC 69097-876-02) and bottle of 500 tablets (NDC 69097-876-12) .
Store bupropion HCl extended-release tablets at 20° to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP .
📋 Description ▾
11 DESCRIPTION Bupropion hydrochloride, USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride.
The molecular weight is 276.2. The molecular formula is C 13 H 18 ClNO·HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water.
It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is: Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg, white to off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: hydroxyl propyl methyl cellulose, microcrystalline cellulose, povidone, citric acid monohydrate, colloidal silicon dioxide, magnesium stearate, methacrylic acid copolymer, talc, titanium dioxide, colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate and triethyl citrate.
Meets USP Dissolution Test 18. image description
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Inform patients, their families, and their caregivers about the benefits and risks associated with treatment with bupropion hydrochloride extended-release tablets (XL) and counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions,” “Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions,” and “What Other Important Information Should I Know About Bupropion Hydrochloride Extended-release Tablets (XL)?” is available for bupropion hydrochloride extended-release tablets (XL).
Instruct patients, their families, and their caregivers to read the Medication Guide and assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Advise patients regarding the following issues and to alert their prescriber if these occur while taking bupropion hydrochloride extended-release tablets (XL). Suicidal Thoughts and Behaviors Instruct patients, their families, and/or their caregivers to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down.
Advise families and caregivers of patients to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.
Neuropsychiatric Adverse Events and Suicide Risk in Smoking Cessation Treatment Although bupropion hydrochloride extended-release tablets (XL) are not indicated for smoking cessation treatment, it contains the same active ingredient as ZYBAN ® which is approved for this use. Inform patients that some patients have experienced changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation and suicide when attempting to quit smoking while taking bupropion.
Instruct patients to discontinue bupropion hydrochloride extended-release tablets and contact a healthcare professional if they experience such symptoms [ see Warnings and Precautions (5.2) and Adverse Reactions (6.2) ]. Severe Allergic Reactions Educate patients on the symptoms of hypersensitivity and to discontinue bupropion if they have a severe allergic reaction. Seizure Instruct patients to discontinue and not restart bupropion if they experience a seizure while on treatment.
Advise patients that the excessive use or the abrupt discontinuation of alcohol, benzodiazepines, antiepileptic drugs, or sedatives/hypnotics can increase the risk of seizure. Advise patients to minimize or avoid the use of alcohol. Angle-Closure Glaucoma Patients should be advised that taking bupropion can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma.
Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients…
💬 Medication Guide ▾
MEDICATION GUIDE Bupropion Hydrochloride Extended-Release tablets (XL) (bue proe' pee on hye'' droe klor' ide) IMPORTANT: Be sure to read the three sections of this Medication Guide. The first section is about the risk of suicidal thoughts and actions with antidepressant medicines; the second section is about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with medicines used to quit smoking; and the third section is entitled “What Other Important Information Should I Know About bupropion hydrochloride extended-release tablets (XL)?” Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions This section of the Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines.
What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? Antidepressant medicines may increase the risk of suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment. Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions.
Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
Keep all follow up visits with your healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling very agitated or restless • panic attacks • trouble sleeping (insomnia) • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking (mania) • other unusual changes in behavior or mood What else do I need to know about antidepressant medicines?
Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms. Antidepressants are medicines used to treat depression and other illnesses.
It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants. Antidepressant medicines have other side effects.
Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member. Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes.
Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider. It is not known if bupropion hydrochloride extended-release tablets (XL) are safe and effective in children under the age of 18.
Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions This section of the Medication Guide is only about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with…