Prescription drug · ANDA
Bupropion Hydrochloride XL (Bupropion hydrochloride) NDC 0591-3331
Bupropion hydrochloride 150 mg/1 · Tablet, Film coated, Extended release · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0591-3331Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00591-3331Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-3331-05 | 0059133310500591333105 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3331-05)Marketed from Nov 26, 2008 | |
| 0591-3331-19 | 0059133311900591333119 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3331-19)Marketed from Nov 26, 2008 | |
| 0591-3331-30 | 0059133313000591333130 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3331-30)Marketed from Nov 26, 2008 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 XLSuffix: XL
- Generic name (nonproprietary)
- bupropion hydrochloride
- Active ingredients
- Bupropion hydrochloride — 150 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.NDC labeler code 0591
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077715
- 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 0591-3331_98589086-9e0e-4672-8a2b-f69c10b96bacSPL ID 98589086-9e0e-4672-8a2b-f69c10b96bac
- 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
N400591333105followed by a unit qualifier and the quantityPackage 00591-3331-05. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0591-3331
- What is NDC 0591-3331?
- 0591-3331 is the product NDC for Bupropion Hydrochloride XL (bupropion hydrochloride), Bupropion hydrochloride 150 mg/1 tablet, film coated, extended release, listed with the FDA by Actavis Pharma, Inc.. 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?
- Actavis Pharma, Inc., NDC labeler code 0591. 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 077715
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 XLbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-4049 |
| Bupropion Hydrochloride XLbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 63187-766 |
| Bupropion Hydrochloride XLbupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Asclemed USA, Inc. | 76420-923 |