Prescription drug · ANDA
Bupropion Hydrochloride SR (bupropion hydrochloride) NDC 63187-566
Bupropion hydrochloride 200 mg/1 · Tablet, Film coated, Extended release · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-566-30 | 63187056630 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-566-30)Marketed from Dec 1, 2018 | |
| 63187-566-60 | 63187056660 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-566-60)Marketed from Dec 1, 2018 | |
| 63187-566-90 | 63187056690 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-566-90)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 Hydrochloride SRSuffix: SR
- Generic name (nonproprietary)
- bupropion hydrochloride
- Active ingredients
- Bupropion hydrochloride — 200 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079095
- 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 63187-566_c925c162-1843-4844-81d6-781b8f6d5d30SPL ID c925c162-1843-4844-81d6-781b8f6d5d30SPL set ID a165869a-9bc4-4987-babe-a77fad78c38fRxCUI 993536UNII 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
N463187056630followed by a unit qualifier and the quantityPackage 63187-0566-30. 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 (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM ) . The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14 )] . The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14 )] . • Bupropion hydrochloride extended-release tablets, USP (SR), are an aminoke…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 079095
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 SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 43063-913 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 63187-726 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coated, Extended releaseOral | Actavis Pharma, Inc. | 0591-3540 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Actavis Pharma, Inc. | 0591-3541 |
| BuPROPion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coated, Extended releaseOral | American Health Packaging | 68084-697 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Film coated, Extended releaseOral | Actavis Pharma, Inc. | 0591-3542 |
| BuPROPion Hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | American Health Packaging | 68084-708 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-0135 |
| Bupropion Hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 63187-952 |