Prescription drug · ANDA
Bupropion Hydrochloride NDC 60505-0158
Bupropion hydrochloride 75 mg/1 · Tablet, Film coated · Oral · Apotex Corp
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-0158-1 | 60505015801 | 100 TABLET, FILM COATED in 1 BOTTLE (60505-0158-1)Marketed from Jan 17, 2006 | |
| 60505-0158-3 | 60505015803 | 30 TABLET, FILM COATED in 1 BOTTLE (60505-0158-3)Marketed from Jan 17, 2006 | |
| 60505-0158-5 | 60505015805 | 500 TABLET, FILM COATED in 1 BOTTLE (60505-0158-5)Marketed from Jan 17, 2006 | |
| 60505-0158-7 | 60505015807 | 1000 TABLET, FILM COATED in 1 BOTTLE (60505-0158-7)Marketed from Jan 17, 2006 | |
| 60505-0158-9 | 60505015809 | 90 TABLET, FILM COATED in 1 BOTTLE (60505-0158-9)Marketed from Jan 17, 2006 |
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
- Generic name (nonproprietary)
- bupropion hydrochloride
- Active ingredients
- Bupropion hydrochloride — 75 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Apotex CorpNDC labeler code 60505
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076143
- 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 60505-0158_9d602b2e-4f88-650d-f47e-d63fb7aacf92SPL ID 9d602b2e-4f88-650d-f47e-d63fb7aacf92SPL set ID 86530199-999b-9f92-b1bc-b8515ec829f3RxCUI 993687, 993691UNII 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
N460505015801followed by a unit qualifier and the quantityPackage 60505-0158-01. 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 tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets 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 )]. Bupropion hydrochloride tablets are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 60505-0158
- What is NDC 60505-0158?
- 60505-0158 is the product NDC for Bupropion Hydrochloride, Bupropion hydrochloride 75 mg/1 tablet, film coated, listed with the FDA by Apotex Corp. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bupropion Hydrochloride.
- What is the active ingredient?
- Bupropion hydrochloride.
- Who is the labeler?
- Apotex Corp, NDC labeler code 60505. 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?
- 177 other product NDCs are listed under this name. See all Bupropion Hydrochloride 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 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 | Bupropion hydrochloride 300 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4739 | 70518-4739-00 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1143 | 67046-1143-03 |
| Bupropion Hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 59651-511 | 59651-0511-0559651-0511-3059651-0511-90 |
| Bupropion Hydrochloride | Bupropion hydrochloride 300 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 59651-512 | 59651-0512-0559651-0512-3059651-0512-90 |
| Bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1273 | 67046-1273-03 |
| Bupropion hydrochloride | Bupropion hydrochloride 300 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-014 | 87441-0014-01 |
| bupropion hydrochloride | Bupropion hydrochloride 150 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4674 | 70518-4674-0070518-4674-01 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | Amici Pharma, Inc. | 69292-601 | 69292-0601-01 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | Amici Pharma, Inc. | 69292-602 | 69292-0602-01 |
| bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | TabletOral | Coupler LLC | 67046-1672 | 67046-1672-03 |
Other NDCs under ANDA 076143
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 | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-308 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-309 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6636 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-340 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1566 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-351 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | Apotex Corp | 60505-0157 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1143 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-708 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-123 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0182 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-127 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2097 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2098 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7988 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-774 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-8180 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2577 |
| Bupropion Hydrochloride | Bupropion hydrochloride 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1869 |
| Bupropion Hydrochloride | Bupropion hydrochloride 75 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-880 |
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