Prescription drug · ANDA
Bupropion Hydrochloride NDC 59651-846
Bupropion hydrochloride 100 mg/1 · Tablet, Film coated, Extended release · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-846-01 | 59651084601 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-846-01)Marketed from Jun 3, 2025 | |
| 59651-846-05 | 59651084605 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-846-05)Marketed from Jun 3, 2025 |
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, Extended release
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090325
- 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 59651-846_b9ab1deb-dba4-4403-9121-936278cc4cfeSPL ID b9ab1deb-dba4-4403-9121-936278cc4cfeSPL set ID 8f86f677-2ebd-43c4-b2dd-2e07d4d54147RxCUI 993503, 993518, 993536UNII ZG7E5POY8OUPC 0359651847015
- 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
N459651084601followed by a unit qualifier and the quantityPackage 59651-0846-01. 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 extended-release tablets (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 hydrochloride extended-release tablets (SR) 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 …
Excerpt only. Read the full label for complete information.
About NDC 59651-846
- What is NDC 59651-846?
- 59651-846 is the product NDC for Bupropion Hydrochloride, Bupropion hydrochloride 100 mg/1 tablet, film coated, extended release, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bupropion Hydrochloride.
- What is the active ingredient?
- Bupropion hydrochloride.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 59651. 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 Hydrochloride?
- 177 other product NDCs are listed under this name. See all Bupropion Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bupropion Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4739 | 70518-4739-00 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1143 | 67046-1143-03 |
| Bupropion Hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 59651-511 | 59651-0511-0559651-0511-3059651-0511-90 |
| Bupropion Hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 59651-512 | 59651-0512-0559651-0512-3059651-0512-90 |
| Bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1273 | 67046-1273-03 |
| Bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-014 | 87441-0014-01 |
| bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4674 | 70518-4674-0070518-4674-01 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | Amici Pharma, Inc. | 69292-601 | 69292-0601-01 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | Amici Pharma, Inc. | 69292-602 | 69292-0602-01 |
| bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | TabletOral | Coupler LLC | 67046-1672 | 67046-1672-03 |
Other NDCs under ANDA 090325
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 150 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 59651-847 |
| Bupropion Hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 59651-848 |