Prescription drug · ANDA
Bupropion Hydrochloride (XL) (Bupropion hydrochloride) NDC 82804-013
Bupropion hydrochloride 300 mg/1 · Tablet, Extended release · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-013-30 | 8280400133082804001330 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-013-30)Marketed from Sep 21, 2023 | |
| 82804-013-60 | 8280400136082804001360 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-013-60)Marketed from Sep 21, 2023 | |
| 82804-013-90 | 8280400139082804001390 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-013-90)Marketed from Sep 21, 2023 |
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 (XL)Suffix: (XL)
- Generic name (nonproprietary)
- bupropion hydrochloride
- Active ingredients
- Bupropion hydrochloride — 300 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 82804
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206556
- 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 82804-013_80f4a4ef-8190-458d-af2e-5daaf32abc01SPL ID 80f4a4ef-8190-458d-af2e-5daaf32abc01SPL set ID 80f4a4ef-8190-458d-af2e-5daaf32abc01RxCUI 993557UNII ZG7E5POY8OUPC 0382804013302
- 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
N482804001330followed by a unit qualifier and the quantityPackage 82804-0013-30. 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 tablet, (XL) is an aminoketone antidepressant, indicated for • treatment of major depressive disorder (MDD) ( 1.1 ) • prevention of seasonal affective disorder (SAD) ( 1.2 ) 1.1 Major Depressive Disorder (MDD) Bupropion hydrochloride extended-release tablets, (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maint…
Excerpt only. Read the full label for complete information.
About NDC 82804-013
- What is NDC 82804-013?
- 82804-013 is the product NDC for Bupropion Hydrochloride (XL) (bupropion hydrochloride), Bupropion hydrochloride 300 mg/1 tablet, extended release, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bupropion Hydrochloride (XL) (Bupropion hydrochloride).
- What is the active ingredient?
- Bupropion hydrochloride.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. 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 (XL)?
- 72 other product NDCs are listed under this name. See all Bupropion Hydrochloride (XL) 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 (XL) 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 (XL)bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Film coated, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-4172 | 68788-4172-0168788-4172-0368788-4172-06+2 more |
| Bupropion Hydrochloride XLbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-0699 | 67046-0699-03 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Northwind Health Company, LLC | 82868-097 | 82868-0097-96 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Film coated, Extended releaseOral | Advanced Rx of Tennessee, LLC | 80425-0539 | 80425-0539-0180425-0539-0280425-0539-03 |
| Bupropion Hydrochloride XLbupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4446 | 70518-4446-00 |
| Bupropion Hydrochloride XLbupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Advanced Rx of Tennessee, LLC | 80425-0468 | 80425-0468-0180425-0468-0280425-0468-03 |
| Bupropion Hydrochloride XLbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Major Pharmaceuticals | 0904-7505 | 00904-7505-0400904-7505-61 |
| Bupropion Hydrochloride XLbupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Major Pharmaceuticals | 0904-7469 | 00904-7469-04 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Quality Care Products, LLC | 83008-082 | 83008-0082-30 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Mullan Pharmaceutical Inc. | 83301-0025 | 83301-0025-0183301-0025-0283301-0025-03+1 more |
Other NDCs under ANDA 206556
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 (XL)bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | CIPLA USA INC., | 69097-875 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | CIPLA USA INC., | 69097-876 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Exelan Pharmaceuticals Inc. | 76282-480 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Exelan Pharmaceuticals Inc. | 76282-481 |