Prescription drug · ANDA
Bupropion Hydrochloride NDC 63187-819
Bupropion hydrochloride 300 mg/1 · Tablet, Extended release · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-819-30 | 63187081930 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-819-30)Marketed from Feb 1, 2017 | |
| 63187-819-60 | 63187081960 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-819-60)Marketed from Feb 1, 2017 | |
| 63187-819-78 | 63187081978 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-819-78)Marketed from Feb 1, 2017 | |
| 63187-819-90 | 63187081990 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-819-90)Marketed from Feb 1, 2017 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- Generic name (nonproprietary)
- bupropion hydrochloride
- Active ingredients
- Bupropion hydrochloride — 300 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077285
- 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 63187-819_a35c75a3-e0fd-4031-8f4c-b350cac13875SPL ID a35c75a3-e0fd-4031-8f4c-b350cac13875SPL set ID 9e2d9c1e-a1de-491d-8f64-34ae60419611RxCUI 993557UNII ZG7E5POY8OUPC 0363187819309
- 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
N463187081930followed by a unit qualifier and the quantityPackage 63187-0819-30. 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, USP (XL) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. ( 1 ) 1.1 Major Depressive Disorder Bupropion hydrochloride extended-release tablets, USP (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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077285
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 | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | HAWAII REPACK, INC. | 85534-0006 |
| Bupropion Hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Actavis Pharma, Inc. | 45963-142 |
| Bupropion Hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Asclemed USA, Inc. | 76420-812 |