Prescription drug · ANDA
Bupropion Hydrochloride NDC 46708-127
Bupropion hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-127-31 | 46708012731 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-127-31)Marketed from Jun 18, 2018 | |
| 46708-127-71 | 46708012771 | 500 TABLET, FILM COATED in 1 BOTTLE (46708-127-71)Marketed from Jun 18, 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
- Generic name (nonproprietary)
- bupropion hydrochloride
- Active ingredients
- Bupropion hydrochloride — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203013
- 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 46708-127_b09bdaa7-0871-4741-b5cd-dd30d683613cSPL ID b09bdaa7-0871-4741-b5cd-dd30d683613cSPL set ID ef0bb8f2-7710-4236-8b47-57b74c8bca3eRxCUI 993687, 993691UNII ZG7E5POY8OUPC 0346708127312, 0346708118310
- 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
N446708012731followed by a unit qualifier and the quantityPackage 46708-0127-31. 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 USP 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 USP 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)] . Bupropion hydrochloride tablets USP are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203013
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 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-118 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4218 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-118 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-127 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4264 |