Prescription drug · ANDA
Bupropion Hydrochloride (XL) (bupropion hydrochloride) NDC 50090-5334
Bupropion hydrochloride 300 mg/1 · Tablet, Extended release · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5334-0 | 50090533400 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5334-0)Marketed from Nov 3, 2020 | |
| 50090-5334-1 | 50090533401 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5334-1)Marketed from Nov 3, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Bupropion Hydrochloride (XL)Suffix: (XL)
- Generic name (nonproprietary)
- bupropion hydrochloride
- Active ingredients
- Bupropion hydrochloride — 300 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210081
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Uptake Inhibitors (Mechanism)Increased Dopamine Activity (Physiologic effect)Increased Norepinephrine Activity (Physiologic effect)Norepinephrine Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-5334_c799e3b4-7b1b-440e-ad0a-02eee6a2d8dfSPL ID c799e3b4-7b1b-440e-ad0a-02eee6a2d8dfSPL set ID ef8ef9ba-ab2a-4af9-ac11-12dd1b603a4aRxCUI 993557UNII ZG7E5POY8O
- Pharmacologic class
- Aminoketone
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450090533400followed by a unit qualifier and the quantityPackage 50090-5334-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: • treatment of major depressive disorder (MDD) ( 1.1 ) • prevention of seasonal affective disorder (SAD) ( 1.2 ) 1.1 Major 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 main…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210081
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7110 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7109 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-968 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-967 |