Prescription drug · ANDA
bupropion (Bupropion hydrochloride) NDC 51655-357
Bupropion hydrochloride 150 mg/1 · Tablet, Film coated, Extended release · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51655-357-26 | 5165503572651655035726 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-357-26)Marketed from May 28, 2020 | |
| 51655-357-52 | 5165503575251655035752 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-357-52)Marketed from Sep 1, 2022 |
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 hydrochloride
- Active ingredients
- Bupropion hydrochloride — 150 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Northwind Health Company, LLCNDC labeler code 51655
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202304
- 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 51655-357_48eb77d6-27c5-cf5e-e063-6394a90a564cSPL ID 48eb77d6-27c5-cf5e-e063-6394a90a564cSPL set ID ab6cd2ea-507c-35e5-e053-2a95a90ac5cbRxCUI 993518UNII 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
N451655035726followed by a unit qualifier and the quantityPackage 51655-0357-26. 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 (SR) tablets 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 (SR) tablets 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 51655-357
- What is NDC 51655-357?
- 51655-357 is the product NDC for bupropion (bupropion hydrochloride), Bupropion hydrochloride 150 mg/1 tablet, film coated, extended release, listed with the FDA by Northwind Health Company, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- bupropion (Bupropion hydrochloride).
- What is the active ingredient?
- Bupropion hydrochloride.
- Who is the labeler?
- Northwind Health Company, LLC, NDC labeler code 51655. 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) |
|---|---|---|---|---|---|
| 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 | Proficient Rx LP | 63187-521 | 63187-0521-3063187-0521-6063187-0521-90 |
| 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 202304
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 |
|---|---|---|---|---|
| bupropionbupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-0801 |
| bupropion hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-7099 |
| bupropionbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-565 |
| bupropion hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coated, Extended releaseOral | Solco Healthcare US LLC | 43547-288 |
| bupropion hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Solco Healthcare US LLC | 43547-289 |
| bupropion hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 200 mg/1 | Tablet, Film coated, Extended releaseOral | Solco Healthcare US LLC | 43547-290 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Extended releaseOral | DIRECT RX | 72189-057 |
| bupropion hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-7465 |
| bupropion hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Cardinal Health 107, LLC | 55154-0183 |
| bupropion hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4591 |
| bupropion hydrochloride SRbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | QPharma Inc | 42708-205 |