Prescription drug · ANDA
Bupropion Hydrochloride (XL) (Bupropion hydrochloride) NDC 83301-0025
Bupropion hydrochloride 300 mg/1 · Tablet, Extended release · Oral · Mullan Pharmaceutical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83301-0025-1 | 8330100250183301002501 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0025-1)Marketed from Jun 17, 2024 | |
| 83301-0025-2 | 8330100250283301002502 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0025-2)Marketed from Jun 17, 2024 | |
| 83301-0025-3 | 8330100250383301002503 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0025-3)Marketed from Jun 17, 2024 | |
| 83301-0025-4 | 8330100250483301002504 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0025-4)Marketed from Jun 17, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Generic name (nonproprietary)
- bupropion hydrochloride
- Active ingredients
- Bupropion hydrochloride — 300 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Mullan Pharmaceutical Inc.NDC labeler code 83301
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208652
- 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 83301-0025_4990307c-8f79-4a7b-e063-6294a90a7b94SPL ID 4990307c-8f79-4a7b-e063-6294a90a7b94SPL set ID 75b1e027-4c5d-46e5-98ee-033e67bd411cRxCUI 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
N483301002501followed by a unit qualifier and the quantityPackage 83301-0025-01. 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 (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 maintenan…
Excerpt only. Read the full label for complete information.
About NDC 83301-0025
- What is NDC 83301-0025?
- 83301-0025 is the product NDC for Bupropion Hydrochloride (XL) (bupropion hydrochloride), Bupropion hydrochloride 300 mg/1 tablet, extended release, listed with the FDA by Mullan Pharmaceutical Inc.. It has 4 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?
- Mullan Pharmaceutical Inc., NDC labeler code 83301. 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 150 mg/1 | Tablet, Extended releaseOral | Mullan Pharmaceutical Inc. | 83301-0024 | 83301-0024-0183301-0024-0283301-0024-03+1 more |
Other NDCs under ANDA 208652
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 | Lannett Company Inc. | 0527-2415 |
| Bupropion hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Lannett Company Inc. | 0527-2430 |
| Bupropion Hydrochloride (XL) | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-875 |
| Bupropion Hydrochloride (XL) | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC | 62135-876 |
| Bupropion hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Vitruvias Therapeutics | 69680-157 |
| Bupropion hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Vitruvias Therapeutics | 69680-158 |
| Bupropion Hydrochloride (XL)bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Mullan Pharmaceutical Inc. | 83301-0024 |