Prescription drug · ANDA
bupropion NDC 65841-780
Bupropion hydrochloride 300 mg/1 · Tablet, Extended release · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65841-780-05 | 65841078005 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-780-05)Marketed from Feb 15, 2014 | |
| 65841-780-06 | 65841078006 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-780-06)Marketed from Feb 15, 2014 | |
| 65841-780-10 | 65841078010 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-780-10)Marketed from Feb 15, 2014 | |
| 65841-780-16 | 65841078016 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-780-16)Marketed from Feb 15, 2014 |
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
- Active ingredients
- Bupropion hydrochloride — 300 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 65841
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201567
- 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 65841-780_6c831525-a7c2-4ef1-b1b9-c7e8cb807dedSPL ID 6c831525-a7c2-4ef1-b1b9-c7e8cb807dedSPL set ID 78d34aad-9d4f-48c4-91eb-536e31c6b6c9RxCUI 993541, 993557UNII 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
N465841078005followed by a unit qualifier and the quantityPackage 65841-0780-05. 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 .
About NDC 65841-780
- What is NDC 65841-780?
- 65841-780 is the product NDC for bupropion, Bupropion hydrochloride 300 mg/1 tablet, extended release, listed with the FDA by Zydus Lifesciences Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- bupropion.
- What is the active ingredient?
- Bupropion hydrochloride.
- Who is the labeler?
- Zydus Lifesciences Limited, NDC labeler code 65841. 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) |
|---|---|---|---|---|---|
| bupropionbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Northwind Health Company, LLC | 51655-357 | 51655-0357-2651655-0357-52 |
| 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 Pharmaceuticals USA Inc. | 68382-354 | 68382-0354-0568382-0354-0668382-0354-10+1 more |
Other NDCs under ANDA 201567
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 | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-353 |
| bupropion | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-354 |
| bupropion | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 63187-521 |
| bupropion | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 65841-836 |