Prescription drug · ANDA
bupropion NDC 63187-521
Bupropion hydrochloride 300 mg/1 · Tablet, Extended release · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-521-30 | 63187052130 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-521-30)Marketed from Dec 1, 2018 | |
| 63187-521-60 | 63187052160 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-521-60)Marketed from Dec 1, 2018 | |
| 63187-521-90 | 63187052190 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-521-90)Marketed from Dec 1, 2018 |
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
- Generic name (nonproprietary)
- bupropion
- Active ingredients
- Bupropion hydrochloride — 300 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201567
- 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 63187-521_001c902a-af30-40fb-bb22-cc18bd8fc94cSPL ID 001c902a-af30-40fb-bb22-cc18bd8fc94cSPL set ID 47ceb7e1-b2f7-47f8-8b6a-85eea36606b8RxCUI 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
N463187052130followed by a unit qualifier and the quantityPackage 63187-0521-30. 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)
1. INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets, USP (XL) is 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 adul…
Excerpt only. Read the full label for complete information.
About NDC 63187-521
- What is NDC 63187-521?
- 63187-521 is the product NDC for bupropion, Bupropion hydrochloride 300 mg/1 tablet, extended release, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- bupropion.
- What is the active ingredient?
- Bupropion hydrochloride.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for bupropion?
- 7 other product NDCs are listed under this name. See all bupropion NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other bupropion products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| bupropionbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Northwind Health Company, LLC | 51655-357 | 51655-0357-2651655-0357-52 |
| bupropion | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 65841-836 | 65841-0836-0565841-0836-0665841-0836-10+1 more |
| bupropion | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-353 | 68382-0353-0568382-0353-0668382-0353-10+1 more |
| bupropionbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-565 | 71205-0565-3071205-0565-6071205-0565-90 |
| bupropionbupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-0801 | 71335-0801-0171335-0801-0271335-0801-03+3 more |
| bupropion | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 65841-780 | 65841-0780-0565841-0780-0665841-0780-10+1 more |
| bupropion | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-354 | 68382-0354-0568382-0354-0668382-0354-10+1 more |
Other NDCs under ANDA 201567
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 | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-353 |
| bupropion | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-354 |
| bupropion | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 65841-780 |
| bupropion | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 65841-836 |