Prescription drug · ANDA
bupropion Hydrochloride NDC 23155-192
Bupropion hydrochloride 100 mg/1 · Tablet · Oral · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 23155-192-01 | 23155019201 | 100 TABLET in 1 BOTTLE (23155-192-01)Marketed from Aug 19, 2016 | |
| 23155-192-10 | 23155019210 | 1000 TABLET in 1 BOTTLE (23155-192-10)Marketed from Aug 19, 2016 |
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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206975
- 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 23155-192_b72f6124-e8e4-42b7-8095-771ff429e936SPL ID b72f6124-e8e4-42b7-8095-771ff429e936SPL set ID 9196568e-aec8-4d56-993e-4cbb78d4a3a6RxCUI 993687, 993691UNII ZG7E5POY8OUPC 0323155191011, 0323155192018
- 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
N423155019201followed by a unit qualifier and the quantityPackage 23155-0192-01. 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 tablets are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ( 1 ) Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets 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) ].
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206975
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 75 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0791 |
| bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-390 |
| bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-191 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | TabletOral | Chartwell RX, LLC | 62135-723 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | TabletOral | Chartwell RX, LLC | 62135-724 |
| bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2400 |
| bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2401 |
| bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | TabletOral | Coupler LLC | 67046-1672 |
| bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2867 |
| bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2875 |
| bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-544 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | TabletOral | MAJOR PHARMACEUTICALS | 0904-7529 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | TabletOral | MAJOR PHARMACEUTICALS | 0904-7530 |
| bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2690 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | TabletOral | Coupler LLC | 67046-1562 |
| bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-866 |
| bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-994 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | TabletOral | Coupler LLC | 67046-1587 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-899 |